MEDTECH REVIEWS 2: Introducing TMS (Transcranial Magnetic Stimulation)

The Modern Age of Non-Invasive Mental Health Innovations: Transcranial Magnetic Stimulation
Written By: Jessica Connell-Glynn | Dr. Robert L. Bard & the editorial team of prevention101.org

In the continued expansion of the medical society to “go non-invasive” (or non-surgical) and the trending reassessment of interventional medications, the mental health community has acquired major tools in its toolbox to support clinical diagnostic and treatment efforts.  In 2008, the FDA approved the first TMS Depression Device for Depression Treatment [1]. In 2018, the FDA approved the marketing of Repeated Transcranial Magnetic Stimulation (rTMS) as adjunct therapy for of obsessive compulsive disorder (OCD) [2-3].  

Current reports have presented an est. 30% of depression cases have a resistance to antidepressant drugs, where Transcranial Magnetic Stimulation (TMS) and the application of Transcranially applied non-invasive neuro-magnetic intervention has shown positive results in combination with antidepressants in patients with treatment-resistant depression[ 4]. 

During the procedure, a magnetic coil is positioned at the head of the person receiving the treatment using anatomical landmarks on the skull, in particular the inion and nasion.[5] The coil is then connected to a pulse generator, or stimulator, that delivers electric current to the coil.[6] Single or paired pulse TMS causes neurons in the neocortex under the site of stimulation to depolarize and discharge an action potential. [7] Repetitive TMS produces longer-lasting effects which persist past the period of stimulation. rTMS can increase or decrease the excitability of the corticospinal tract depending on the intensity of stimulation, coil orientation, and frequency. [8]

Field Report: TMS Science from the Top Developers

Based on an interview with Nexstim Vice President, STEVE BELLER

TMS, or transcranial magnetic stimulation, is the use of magnets external to the body to activate tissue inside the body (so you're not having to open the patient up).  Based on Faraday’s Law, a magnetic field produced outside of a patient’s head can permeate non-invasively through a patient’s head and induce an electric field that has the capacity to activate neurons in the brain. We induce current at a distance inside the brain and cause the neurons to fire where we induce that current.  This means that where we depolarize, we cause the brains neurons to fire.  TMS artificially stimulates the brain and causes the neurons to fire.  Navigation technology allows us to see precisely where in the brain where we are stimulating.

The value of this stimulation effect is twofold; the first is DIAGNOSTIC- where we can non-invasively identify specific areas of motor function and specific areas of language function. The second function is THERAPEUTIC- where we can actually help change or fix an identified brain disease by using TMS. Right now,  we as a company hold FDA clearances for pre-operative motor and language mapping as well as treating major depressive disorder. For depression: the general understanding (still under exploration like a lot of things in medicine, particularly with the brain) is that the metabolic activity in the left dorsal lateral prefrontal cortex in a diseased or depressed patient is lower and usually significantly lower than in out of a healthy patient. In order to increase the metabolic activity and the left dorsal lateral prefrontal cortex or left DLPFC you can use TMS to artificially stimulate our cause the neurons to fire in the left DLPFC and that increases the neuronal excitability level and helps improve the depressive state of that patient.  This is one example of how to therapeutically use TMS to improve health and performance. 

You can also use a different set of TMS stimulation parameters to inhibit brain regions that may be overactive. That is, you can actually slow down the functioning of the cortical area that you're targeting. Hence, TMS in therapeutics may be a versatile option to treat a range of neurologic and psychiatric disorders in the future.

 

EXTRA: Navigated TMS for Pre-Procedural Brain Surgery Since 2009, Nexstim´s Navigated Brain Stimulation (NBS) has been FDA cleared for use in non‐invasive motor and language functional cortical mapping prior to radiosurgery and invasive neurosurgery. This technology allows the operator to move a hand‐held TMS coil over the patient´s head delivering a series of harmless magnetic pulses whose electric fields gently activate neurons in the cortex. Converting a standard head MRI into a 3D‐model of the patient´s brain, allows the operator to precisely navigate the coil´s electric field anywhere in the cortex, much like driving a car with the aid of GPS. Measuring patient responses by electromyography (EMG) reveals the locations of the vital motor areas inside the brain. Mitchel Berger, M.D, Past Chairman of the Department of Neurological Surgery, Past Director of the Brain Tumor Surgery Program, University of California, San Francisco, said, “What makes this so special is the ability for it to define very small, precise cortical regions on the surface of the brain, and define individual components of function which is something we never could do before." The Nexstim technology is available to patients at over 50 of the country’s top neurosurgery programs.

 

2021 REVIEW OF POST TRAUMATIC RECALL

 (A field report by: Jessica Connell-Glynn, LCSW)

 PTSD can occur in all different extremes with at-risk professionals (like cops, responders and veterans). The trauma that they experience are above the ordinary that they could cause extreme flashbacks, anxiety and depression—heavily affecting their quality of life. The average civilian is also prone to this disorder starting with MICRO-TRAUMAS that can happen to everybody throughout any point in their lifetime.  Usually stemmed from childhood issues, micro-traumas actually shape the way an individual reacts to other people. As an example, child bullying may lead to developing a protective or defensive personality disorder.  Anytime they feel disrespected or embarrassed by others, feelings of extreme uncontrollable anger may arise without knowing the source of the hurt or why they're acting in that way.  This dilemma often causes problems in relationships.

 

LANGUISHING: EMOTIONAL CRISIS FROM THE PANDEMIC

 By: Jessica A. Conner-Glynn, LMSW  / Edited by: Cheri Ambrose (NYCRA NEWS writing staff)

 Observing the many emotional after-effects of our ‘new Covid lifestyle’, I find a link between stepping away one's our work environment and a direct improvement in one’s well-being. The surge of the coronavirus pandemic brought a unique kind of widespread emotional disorder called LANGUISHING- an issue identified as somewhere between a downturn ‘blah’, emptiness or depression causing a type of burnout from mandatory social distancing.  Many of us are working really hard in the same place that we actually live- removing that safe separation between work and home that we once had.  The shift in working at home takes away that place to relax and shut down, eventually causing a state of emotional exhaustion from staying ON (and on guard) the whole time.  There is also a physical aspect to all this; the new sedentary lifestyle of working from home eliminates the vital energy stimulation from circulation and cardiovascular activity of physical traveling.  In addition, self-isolating has induced an unhealthy weight gain in many, also adding to this malaise.

 

HOW STRESS CAN MAKE YOU SICK By: Dr. Jesse A. Stoff 

 For our well-being, stress is so powerful that it can affect just about every function in our bodies right down to our cells. Stress can cause major weight gain, headaches, hair loss, dental problems, major fatigue, respiratory issues, digestive problems, psychological & focal disorders.  It is also known to affect the performance of our immune system - allowing for skin issues, colds, allergies and a host of chronic diseases. Stress management is important for more than psychological health; stress can greatly affect immune functioning, inflammation and even hormonal balance. Studies have shown that stress can reduce natural killer cell function. These are normally the cells that attack foreign invaders including viruses, bacteria and fungi. They are also the cells that patrol the body as the first line of defense against the development of cancer.

RETINAL & TRANSCRANIAL IMAGING By Dr. Robert L. Bard

Another device used by imaging specialists to detect mental distress is through an EYE SONOGRAM or  Real Time Sonofluoroscopy of the orbital soft tissues of the eyes.  This process is performed in multiple scan planes with varying transducer configurations and frequencies.  Power and color Doppler use angle 0 degrees and PRF at 0.9 at the optic nerve head. 3D imaging of optic nerve and carotid, central retinal arteries and superficial posterior ciliary arteries performed in erect position before & after verbal communication and orbital muscle tissue contractions may be observed as a precursor to visual changes in facial expression. Retinal arterial directional flow is also measured with peak systolic and diastolic values. Bulging of the optic nerve head is checked as increased intracranial pressure may be demonstrable in this condition. Other innovations such as the TRANSORBITAL DOPPLER, 3D/4D VESSEL DENSITY HISTOGRAM and the RETINAL OCT (optical coherence tomography) are also being explored in the pursuit of studying brain performance through the eyes.  An expanded review on these solutions will be available in part 2 of this report.

 

References:

1) “FDA OKs TMS Depression Device for Brain-Stimulating Device Cleared for Depression Treatment After 1 Drug Failure”- https://www.webmd.com/depression/news/20081008/fda-oks-tms-depression-device

2) https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-transcranial-magnetic-stimulation-treatment-obsessive-compulsive-disorder

3) https://www.hcplive.com/view/prevalence-methamphetamine-use-overdose-death

4) Biological Psychiatry (Journal) /ARCHIVAL REPORT| VOLUME 68, ISSUE 2, P163-169, JULY 15, 2010 Transcranial Low Voltage Pulsed Electromagnetic Fields in Patients with Treatment-Resistant Depression  https://www.biologicalpsychiatryjournal.com/article/S0006-3223(10)00162-9/fulltext

5) Nauczyciel C, Hellier P, Morandi X, Blestel S, Drapier D, Ferre JC, et al. (April 2011). "Assessment of standard coil positioning in transcranial magnetic stimulation in depression". Psychiatry Research. 186 (2–3): 232–8. doi:10.1016/j.psychres.2010.06.012. PMID 20692709. S2CID 25100990.

6) NICE. January 2014 Transcranial magnetic stimulation for treating and preventing migraine.  Michael Craig Miller for Harvard Health Publications. July 26, 2012 Magnetic stimulation: a new approach to treating depression?

7) Pascual-Leone A, Davey N, Rothwell J, Wassermann EM, Puri BK (2002). Handbook of Transcranial Magnetic Stimulation. London: Edward Arnold. ISBN 978-0-340-72009-7.

8) Fitzgerald PB, Fountain S, Daskalakis ZJ (December 2006). "A comprehensive review of the effects of rTMS on motor cortical excitability and inhibition". Clinical Neurophysiology. 117 (12): 2584–96. doi:10.1016/j.clinph.2006.06.712. PMID 16890483. S2CID 31458874.

9) Wikipedia: Transcranial magnetic stimulation  https://en.wikipedia.org/wiki/Transcranial_magnetic_stimulation#cite_note-Handbook_of_Transcranial_Magnetic_Stimulation-27

 

 

 

 

 

WHAT IS PEMF Therapy? (Pulsed ElectroMagnetic Field)- Part 1

NON-INVASIVE ELECTROMAGNETIC THERAPIES (Part 1) 

A report by: Jessica Connell-Glynn / Edited by the NYCRA-NEWS Editorial team

In 2015, Dr. Oz aired a program about an "invisible treatment" for chronic pain designed to "change the practice of medicine"- casting a wave of commercial attention to the patient community desperate for pain relief- and hope for the reversal of pain-related ailments. Pulsed Elecromagnetic Field Thereapy or PEMF is the induction of electromagnetic fields to promote the synthesis of cellular, muscular and skeletal matrix [1].  

Electromagnetic fields (EMFs) provide a non-invasive, safe, and easy method to treat and rehabilitate a growing list of health issues. The therapeutic theory behind this innovation is designed to affect the body at the extracellular level- imposing the ability to transduce or separate mechanical charge to electrical energy.  This has been reported to affect the alignment and physical properties of tissues & cell nutrition toward the healing process.[2]  Electromagnetic fields (EMFs) and magnetic therapy presents a major increase in research attention in the past decade for its ability to directly treat the site of injury. [3]

Medical historians and publishers often attribute the scientific roots of electrical transduction therapy to NIKOLA TESLA (1856-1943) for his pioneer work in advanced electromagnetic field frequency. They align the success of non-invasive treatment innovations including the Pulsed Elecromagnetic Field Thereapy (PEMF) and the Transcranial Magnetic stimulation (TMS) to the philosophy of implementing electgromagnetic fields to stimulate cells.  It is this same paradigm in patient care technology that enforces the very backbone of holistic and non-surgical ("no more scalpel") movement.

Conventional uses of magnetic therapy is widely found in the integrative and alternative (or wellness) communities. Some may recognize this science under other names including:

 Wave Therapy                   Biofeedback                 Bio-resonance

 Magnetic Therapy             Electrostimulation       Microcurrent Therapy

These devices vary in size & designs but these protocols are similar in application.  The science employs a magnetic field for rehabilitation to treat and/or prevent diseases.

CLEARED FOR USES

In 1979, The Food and Drug Administration 1979 approved PEMF Therapy for the healing of non-union fractures [4]. Electrical stimulation of the spine (as part of spinal fusion procedures) for failed fusions and congenital pseudarthroses. In October 2008 the Food and Drug Administration approved the use of PEMF therapy for treatment of major depressive disorder in PD patients who failed to achieve satisfactory improvement from very high dosages of antidepressant medications [5].  

Clinical research has also been highly dedicated towards mental health. In 2006, the FDA approved PEMF Therapy for treatment of depression and anxiety. [7-9] Further reports have presented an est. 30% of depression cases have a resistance to antidepressant drugs, where Repetitive Transcranial Magnetic Stimulation (rTMS) and the application of Transcranially applied Pulsed Electromagnetic Fields (T-PEMF) has shown positive results in combination with antidepressants in patients with treatment-resistant depression[10].

In 2019 the wearable RecoveryRx PEMF Device was FDA Cleared for "Adjunctive treatment of postoperative pain".  This technology achived market clearance for its drug-free (non-opiod) PostOp effects. Andrew Whelan, President, expressed confidence in seizing the market opportunity: “We are delighted that the FDA has recognized the potential of RecoveryRx in transforming postoperative pain care. RecoveryRx, with its high degree of safety, excellent clinical evidence of effectiveness and exceptional cost-benefit, will become the standard of care.” [11-12]

PEMF: HISTORY & EXPANSION OF MODERN TARGET ISSUES

Claims of electricity induction in aiding bone repair has been reported as far back as the mid 1800's, but it wasn't until the mid-1950's to the '70's that the scientific community significantly advanced its research toward the treatment of delated fractures in Western Europe and the US. Recent reviews have shown benefits of PEMF to include: neurological disorders, vascular disease, lung disorders, GI (gastrointenstinal) disease, rheumatic disease, dermatological issues, inflammation, tumors and immunological issues for both humans and animals.[14] Clinical research studies have reported benefits for a host of specific issues including: musculoskeletal(MSK) Pain [15], bacteria and parasites, OstheoArthritis, mental health disorders (Depression), Multiple Sclerosis[16-17], Cancer[18] and Alzheimer's Disease [19].  

TMS and PEMF USE IN PARKINSON'S DISEASE

Parkinson’s disease (PD) is one of the most common progressive nervous system disorders that affects movement.  It is a neurodegenerative disorder second only to Alzheimer’s disease, accompanied by the impairment of the cortico-subcortical excitation and inhibition systems, hence belonging to the involuntary movement diseases. In the first PD patients treated with high-frequency TMS in 1993, motor symptoms, tremor, rigidity and akinesia improved significantly allowing to decrease the administration of l-dopa by a mean of 55% [20].

TMS FOR DEPRESSION: Transcranial Magnetic Stimulation October 4, 2021- TMS, or transcranial magnetic stimulation, is the use of magnets external to the body to activate tissue inside the body (so you're not having to open the patient up).  Based on Faraday’s Law, a magnetic field produced outside of a patient’s head can permeate non-invasively through a patient’s head and induce an electric field that has the capacity to activate neurons in the brain. We induce current at a distance inside the brain and cause the neurons to fire where we induce that current.  This means that where we depolarize, we cause the brains neurons to fire.  TMS artificially stimulates the brain and causes the neurons to fire.  Navigation technology allows us to see precisely where in the brain where we are stimulating. (see complete article)

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The AOPP: Explaining How PEMF Works

9/25/2021:  An exploratory review* of the PEMF science is under discussion between Dr. Robert Bard and THE AOPP FOUNDATION (Association of PEMF Professionals) which aims to provide clarity on the science behind its 'invisible healing' concept.  AOPP aligned with the Integrative Pain Healers Alliance (Dr. Bard's wellness network) and saw the need for public clarity in how PEMF works, what actual uses they are cleared for as well as the importance of public guidance on the market.

Dr. Jerry Dreesen, President of the AOPP and certified chiropractor by trade is an avid user of this therapeutic technology for his patients on a variety of disorders.  "So PEMF did start out on the animal side... it was originally used for seed germination -and moved over to the animal side.  When they eventually started working with humans, evidence of creating better blood flow as part of the body's detoxification. We're also finding that with PEMF is that the body is utilizing medication even better -  so it's absorbing it and using it more versus some people can be getting a reaction to better absorption of their medications."

Dr. Dreesen further explains the physiological and biological reactions to electromagnetic science and its research - going as far back as the Krebs cycle (otherwise known as The citric acid cycle (CAC) – or  the TCA cycle (tricarboxylic acid cycle)- which we all had to learn. During that process. one of the by products is nitric oxide and then the other one is of course, taking ADP and attaching the phosphate to it and making ATP-- creating the "fuel" for the body.  PEMF sparking this process is great especially for sports where it induces renewed energy to fatigued muscles. For the same reasons why it works really well on animals, the same goes for humans after a workout as it quickly revitalizes the target area by increasing absorption of oxygen and energy levels. 

Dr. Dreesen shares the rehabilitative theories and applications for MSK injuries- including sprains, strains, joint issues, arthritis pain and other chronic inflammation. He describes its performance on a cellular level and controlling inflammation versus "just telling the brain that there's no pain there at all... it's not masking pain, it's physically going in and eliminating the creation of inflammation. As a by-product of going in and oxygenating tissue, creating stem cells, eliminating causing the cellular walls to get rid of product and bringing in nutrients, it rebuilds and refreshes the joints."   He furthers, "for people who have had past injuries in their joints and for whatever reason, never healed properly, PEMF can offer significant change- not only in reducing inflammation, but potentially preventing it from coming back!" 

MEETING DEVELOPERS

Tech critic and test-driver Dr. Robert Bard met with a short list of  AOPP members including Patrick Ziemer, development facilitator and CTO of Aura Wellness PEMF (Aurawell.com) to discuss the growing number of health issues and disorders that neuromagnetic science is slated to manage, treat and even resolve.  As part of his global crusade to support non-invasive medicine, Dr. Bard recognizes the advancing benefits of PEMF throughout the wellness community and is evaluating all devices including the AuraPulse™ technology. 

Mr. Ziemer is a consumer advocate for the AOPP and publishes educational posts about the benefits and his evidence of the PEMF technology to align with his critical thoughts on the industry.  From our interview, he shares his expansive research on the science, allotting for the limited number of actual models that are FDA cleared, approved or registered.   As part of his advocacy, Mr. Ziemer describes the confusion about neuromagnetic therapy to come from companies who presents “rogue claims” about their specific devices.  Many lower-end companies tend to lack the proper extensive safety testing of their devices and espouse claims “from studies done by others that are FDA approved.  For example, companies will make claims that their devices will heal broken bones.  "PEMF has been known to do this, but we can't legally say that about OUR specific device without doing the studies (ourselves) from a formal FDA 510K clearance process … and all companies should take the same responsibility about their work”.  

Mr. Ziemer’s history with PEMF started around 2013, co-developing and promoting the therapeutic use high-voltage PEMF for the equestrian society.  His device appealed greatly to the veterinary community for its ability to address the many health concerns of our four legged friends who rarely complain.  Therapeutically, his PEMF has shown to improve horses’ circulation, increasing blood oxygen, lymphatic stimulation, relaxing muscle spasms, relieving tension, enhancing muscle tone, and increasing the range of motion in high performance horses.  These same health issues expanded his popularity to treat a growing range of patient breeds including cattle, livestock and dogs across the country.

In 2020, Mr. Ziemer’s PEMF officially made its way to human patients at the launch of Aura Wellness- carrying a professional grade, high voltage PEMF device. Applying much of his field expertise with animals, Mr. Ziemer achieved tremendous R&D advantage to apply to his human prototype. His AuraPulse™ model is completely programmable with adjustable intensity levels, digital timers, plug-and-play applicators, and customized session programs.   Dr. Bard is reviewing* all PEMF devices like the AuraPulse™ for its effects and claims for improved wellness.

"Our first test subject was 4 legged and suffered from arthritis. While on the magnetic coil, the poodle visibly became calmer, eventually going to sleep inside the treatment ring. The dog’s handler saw the improvement in the gait and asked to have her shoulder treated. After a 10 minute session, our 2 legged patient reported mild improvement on a chronic rotator cuff disorder and great improvement 12 hours later." 

*It is to be noted that beta testing and clinical evaluation reviews of all medical devices are restricted to their intended uses according to their designated FDA clearances. 

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CONTRIBUTORS

JESSICA CONNELL-GLYNN, LCSW, CPC, CEC is a columnist for Prevention101 newsletter. She often reports on topics concerning mental health, neurological disorders and medical innovations that pertain to 'modern wellness'.   As a therapist and mental health coach, Jessica's primary work involves providing direct support in managing symptoms of personal anxiety and panic. Jessica is also currently leading an interdisciplinary research project with a team of mental health and professionals in neurology to review the current care standards and collaborate on new protocols that target, assess and diagnose psychological disorders.(https://cmpcnyc.com/)

Dr. JERRY DREESSEN is both Trauma Team Qualified and Hospital Qualified treating chiropractor in Mountlake Terrace, WA. He is the Executive Director for the Association of PEMF Professionals- the largest professional PEMF organization in the United States. AOPP attracts the most principled and accomplished PEMF user- setting standards by providing certification for all PEMF users, as well as Continuing Education (CEU's) for all members to maintain best practices and techniques. (www.backtoaction.com)

SPECIAL THANKS
The editors of this spotlight proudly gives thanks to Ms. Suzanne Wheeler for her generosity in sharing her story and her resources with us.  Additional thanks to Dr. Jerry Dreessen of the AOPP (Association of PEMF Professionals) and Pat Ziemer of Magnawave Inc. and Aura Wellness PEMF for coordinating our interviews, shared countless materials and conducted unending support to help our educational program bring new light to PEMF technology for chronic disorders and supportive testimonials in alternative therapeutics.   

VIEWPOINTS from the Healthcare Community Our bodies are made up of 30 to 40 trillion cells at any given point during our lifetime. Each cell is a dynamic electro chemical entity that work together for the better of the whole. This is truly an amazing process. Medicine has been oriented toward rescue type interventions of dysfunction and disease. If there is pathology present;” take it out”. Or use a drug to turn on or turn off the metabolic machinery of specific cells. That is the majority of the mindset of medicine. It is refreshing to learn about other forward thinking modalities and innovations in the healthcare field. These  Innovations like pulsed electromagnetic field therapy(PEMF) and transcranial magnetic stimulation (TMS) are technologies that utilize non-invasive electromagnetic stimulation of cellular metabolic processes within various places in our body.  The endgame of the technologies is for diagnostic information and therapeutic intervention of systemic disease.  PEMF and TMS have proven that electromagnetic fields can provide non-invasive methods to diagnose and treat health concerns such as depression, pain, MS, Cancer, Alzheimer’s Disease, Parkinson’s Disease, healing responses, and Overall cardiovascular anomalies. This is so exciting because we can use this technology two recognize early metabolic and possibly genetic changes that could lead to accelerated aging disease and death. Also, we can use this technology as an intervention to the changes and correct the path of health. Both of these technologies have shown efficacy ( FDA approval) and promise ( more research is being done). There is no question that LESS IS MORE! That is if we recognize pathological conditions early and can correct them with little or no pharmacological or surgical intervention; “everybody wins!”   - By Randall Weisel DDS,MPS  (www.laserhygienics.com)

REFERENCES

1) Ehnert, Sabrina; Schröter, Steffen; Aspera-Werz, Romina H.; Eisler, Wiebke; Falldorf, Karsten; Ronniger, Michael; Nussler, Andreas K. (December 2019). "Translational Insights into Extremely Low Frequency Pulsed Electromagnetic Fields (ELF-PEMFs) for Bone Regeneration after Trauma and Orthopedic Surgery". Journal of Clinical Medicine. 8 (12): 2028. doi:10.3390/jcm8122028. PMC 6947624. PMID 31756999.

2) ACCELERATION OF FRACTURE REPAIR BY ELECTROMAGNETIC FIELDS. A SURGICALLY NONINVASIVE METHOD: First published: October 1974 https://doi.org/10.1111/j.1749-6632.1974.tb26794.x

3) Electromagnetic Field Therapy: A Rehabilitative Perspective in the Management of Musculoskeletal Pain – A Systematic Review J Pain Res. 2020; 13: 1385–1400. Published online 2020 Jun 12. doi: 10.2147/JPR.S231778  PMCID: PMC7297361 PMID: 32606905 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7297361/

4) Electrical stimulation of the spine as an adjunct to spinal fusion procedures". Blue Cross & Blue Shield of Mississippi. Archived from the original on 2015-04-02. Pulsed electromagnetic field systems with FDA PMA include the EBI Bone Healing System from Electrobiology, Inc., which was first approved in 1979 and indicated for nonunions, failed fusions, and congenital pseudarthroses; and the Cervical-Stim from Orthofix, which was approved in 2004 as an adjunct to cervical fusion surgery in patients at high risk for non-fusion. https://web.archive.org/web/20150402122818/http://www.bcbsms.com/index.php/index.php?id=200&action=viewPolicy&path=%2Fpolicy%2Femed%2FElectrical+Stimulation+of+the+Spine+as+an+Adjunct+to+Spinal+Fusion+Procedures.html&source=emed

5) Mechanisms and therapeutic applications of electromagnetic therapy in Parkinson’s disease (BMC/SPRINGER) Behavioral and Brain Functions-

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4562205/#CR125

6) Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data.

Demitrack MA, Thase ME  Psychopharmacol Bull. 2009; 42(2):5-38. https://pubmed.ncbi.nlm.nih.gov/19629020/

7) Pulsed Electro Magnetic Fields (PEMF) in Depression (PEMF)  https://clinicaltrials.gov/ct2/show/NCT03556735

8) Demitrack MA, Thase ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharmacol Bull. 2009;42(2):5–38 - https://pubmed.ncbi.nlm.nih.gov/19629020/

9) Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center- https://pubmed.ncbi.nlm.nih.gov/22579164/

10) Biological Psychiatry (Journal) /ARCHIVAL REPORT| VOLUME 68, ISSUE 2, P163-169, JULY 15, 2010 Transcranial Low Voltage Pulsed Electromagnetic Fields in Patients with Treatment-Resistant Depression  https://www.biologicalpsychiatryjournal.com/article/S0006-3223(10)00162-9/fulltext

11) US FDA- https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf

12) Press Release/BioElectronics Announces FDA Market Clearance for Its Non-Opioid Postoperative Pain Therapy   https://www.globenewswire.com/en/news-release/2019/07/01/1876675/0/en/BioElectronics-Announces-FDA-Market-Clearance-for-Its-Non-Opioid-Postoperative-Pain-Therapy.html

13) 12/10/2009 -FDA clears Nexstim´s Navigated Brain Stimulation for non-invasive cortical mapping prior to neurosurgery (Nexstim Press release)

https://nexstim.com/news-and-events/news/press-release/news/fda-clears-nexstims-navigated-brain-stimulation-for-non-invasive-cortical-mapping-prior-to-neurosur/

14)  Jerabeck, J; Pawluk, W (1998). Magnetic therapy in eastern Europe : a review of 30 years of research. W. Pawluk. ISBN 0-9664227-0-8.

15) Thomas AW, Graham K, Prato FS, McKay J, Forster PM, Moulin DE, et al. A randomized, double-blind, placebo-controlled clinical trial using a low-frequency magnetic field in the treatment of musculoskeletal chronic pain. Pain Res Manage J Can Pain Soc (journal de la societe canadienne pour le traitement de la douleur) 2007;12(4):249–258 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670735/

16)  Lappin MS, Lawrie FW, Richards TL, Kramer ED. Effects of a pulsed electromagnetic therapy on multiple sclerosis fatigue and quality of life: a double-blind, placebo controlled trial. Altern Ther Health Med. 2003;9(4):38–48. https://pubmed.ncbi.nlm.nih.gov/12868251/

17) Richards TL, Lappin MS, Acosta-Urquidi J, Kraft GH, Heide AC, Lawrie FW, et al. Double-blind study of pulsing magnetic field effects on multiple sclerosis. J Altern Complement Med. 1997;3(1):21–29. doi: 10.1089/acm.1997.3.21. https://pubmed.ncbi.nlm.nih.gov/9395691/

18) Barbault A, Costa FP, Bottger B, Munden RF, Bomholt F, Kuster N, et al. Amplitude-modulated electromagnetic fields for the treatment of cancer: discovery of tumor-specific frequencies and assessment of a novel therapeutic approach. J Exp Clin Cancer Res. 2009;28:51. doi: 10.1186/1756-9966-28-51

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2672058/

19) Arendash GW, Sanchez-Ramos J, Mori T, Mamcarz M, Lin X, Runfeldt M, et al. Electromagnetic field treatment protects against and reverses cognitive impairment in Alzheimer’s disease mice. J Alzheimers Dis. 2010;19(1):191–210. https://pubmed.ncbi.nlm.nih.gov/20061638/

20) Behav Brain Funct. 2015; 11: 26. Published online 2015 Sep 7. doi: 10.1186/s12993-015-0070-z

PMCID: PMC4562205  PMID: 26347217  Mechanisms and therapeutic applications of electromagnetic therapy in Parkinson’s disease Maria Vadalà, Annamaria Vallelunga, Lucia Palmieri, Beniamino Palmieri, Julio Cesar Morales-Medina, and Tommaso Iannitti corresponding author https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4562205/

21) The Krebs Cycle: https://en.wikipedia.org/wiki/Citric_acid_cycle

PHOTO CREDITS

* Nikola Tesla in or around 1890, when the inventor was in his mid-30s. | Photo is in the public domain. Image courtesy of the Library of Congress. https://www.energy.gov/articles/top-11-things-you-didnt-know-about-nikola-tesla

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MEET THE INTEGRATIVE PAIN HEALERS ALLIANCE

Modern Innovators of Pain & Injury Care

Aug. 1, 2021- Philanthropist and medical publisher Dr. Robert L. Bard helped to spearhead the formation of a brand new network dedicated to a grouping of pain and injury care professionals.  IPHA - the Integrative Pain Healers Alliance is a private self-funded professional community assembling a synergistic collective of clinical specialists, therapeutic technologists, diagnosticians, innovators, public educators, advocates and patient resources dedicated to supporting physiological care. 

Thanks to the endorsement from various orgs including NANCYSLIST, the AngioFoundation, F.A.C.E.S. Foundation (Firefighters Against Cancer & Exposures), MOVEMBER Foundation and the NY Cancer Resource Alliance, IPHA was formed under tremendous support from the cancer community due to the wide exposure to post-treatment pain and injuries of patients.  Moreover, the establishment of IPHA is highly supported by community groups battling the OPIOD CRISIS.  Inspiring members including Dr. Andrew Rochman (Plainview, NY), a staunch advocate against "America's addiction to pain meds" echoes the need to unite the healers community for one voice. “It is this very attitude about pain that has driven our society into a misguided dependency for the quick fix and has created a major traffic gridlock in information and solutions. Where a western society that once ran a healthy existence on a lean diet and a proactive lifestyle, today's response trend to any discomfort is meds or visiting a specialist.”

IPHA's catalogues all pain therapy innovations as part of awareness 101. The athletic community also has a leadership role in this group; Dr. Noelle Cutter, clinical researcher and top triathlete & Iron-Man runner from Long Island, NY. is a staunch advocate in the IPHA message of alternative and ‘smarter’ treatment solutions. "Numbing the pain is not therapy"... It's time we adjust the way we face our injuries - by focusing on intelligent choices... drugs and surgery are not the only answers to pain!"

THE FUTURE IS NON-INVASIVE MEDICINE

As with most brainstorming relationships, medical pioneers often unite in exploratory research projects.  In the spring of 2021, IPHA supported MedTech Reviews, partnering Dr. Bard's investigative report validating AXIOBIONICS neurostim therapy on MSK pain and injury through the use of real-time ultrasound imaging.  This confirms how pain healing can be tackled non-invasively.  

Through this project, we found remarkable advantages and endless rehabilitative possibilities to Philip Muccio's many innovations in NEURO-PROSTETHICS- the science of integrating advanced wearable therapeutic technology to improve limb performance and to address a wide array of physiological and neurological injuries. For the past 30 years, Mr. Muccio he has been producing custom wearable & intelligent neurostim powered devices for countless patients with major issues where his innovations have brought remarkable results and adding significant improvements to their quality of life.  Just some of the disorders he has addressed. The effects include: SPINAL CORD INJURIES, MSK INJURIES, TRAUMATIC BRAIN INJURIES, CEREBRAL PALSY, STOKE etc.  (See his work at www.AxioBionics.com)

IMPROVING QUALITY OF LIFE: Axiobionics Arm BioSleeve helps a US Veteran regain arm function after a brain injury. Sgt. Shannon Mcallister was injured in an IED blast in Iraq causing a traumatic brain injury and left side paralysis. For more than a year the arm remained frozen and lifeless until he began wearing the Axio BioSleeve muscle stimulation system.  "Sgt. McCallister realized that this technology was going to offer him the hope that he was looking for. And so I convinced Sergeant McAllister to let me design a wearable therapy sleeve, what we call an upper extremity neural prosthesis. We targeted three muscle groups and I wanted to rebuild these muscles for him. So he would have improved upper extremity, strength and control and function. It didn't take very long for him to actually get to the point where he was using the arm again, functionally."

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WHAT IS BIOFEEDBACK?
IPHA is also underway a similar research initiative to confirm other innovations including the widely recognized PEMF (Pulse Electromagnetic Frequency) and BIOFEEDBACK treatment. A recent IPHA member, Dr. Silvia Binder (CEO of ONDAMED) offers an expanded healing capacity to include a full-body diagnostic scan to identify and target disfunction such as Soft Tissue Injuries, internal wounds, inflammation, infection, scars or cellular memory of unresolved shock and trauma.  This biofeedback technology is also known to “successfully manage depression, PTSD and other mental health issues”, according to NY psychiatrist, Dr. George Tawfik. 

Biofeedback is a mind-body technique that involves using visual or auditory feedback to gain control over involuntary bodily functions. This may include gaining voluntary control over such things as heart rate, muscle tension, blood flow, pain perception, and blood pressure. This process involves being connected to a device with sensors that provide feedback about specific aspects of your body.

While stimulating the body with gentle focused pulsed electromagnetic fields similar to what your own body uses for communication purposes, it helps identify stressed areas in the body with the help of the patient's pulse feedback (vascular signal). The identified stressed areas are brought to the patient's attention and stimulated for repair and regeneration of such tissue areas, which are potentially responsible for patients' symptoms and disease processes. This therapy is especially helpful to balance parasympathetic and sympathetic nervous systems, impacting the psyche, immune system, and endocrine system.

HOW IS BIOFEEDBACK USED? Biofeedback has been used for a range of applications, including: - Treating tension headaches, migraines, and other pain - Controlling high and low blood pressure - Alleviating digestive disorders such as irritable bowel syndrome - Helping patients control physical reactions to stress or anxiety - Aiding in relaxation and stress management EEG feedback has also been shown to be beneficial in managing symptoms of certain brain injuries and attention deficit disorder, and there is some evidence suggesting it might be efficacious in depression and post-traumatic stress disorder.

Biofeedback is particularly useful for managing stress as well as symptoms of conditions that may be exacerbated by stress. For example, therapists might use biofeedback to help patients control their responses to stress. Chronic stress can have a wide range of negative health effects including decreased immunity, heart disease, depression, digestive problems, and sleep disorders. By learning how to manage the stress response using biofeedback, patients are able to decrease the harmful physical and psychological effects of stress.

For more information on Biofeedback, visit: ondamed.net

WHAT IS GRAIL? Early Cancer Detection & "Full Body" Cancer Test

Written by: Dr. Robert Bard
Cancer Specialist, NYC)

In the mid-sixties, the medical community and the radiological society were dedicated to the pursuit of non-invasive screening and diagnostic protocols through MEDICAL IMAGING. Early mammography was established as a minimally invasive cancer screening protocol.  Other imaging solutions like the MRI, Pet-CT and the ultrasound were also part of this global  diagnostic movement. [00]- (also see our list of cancer diagnostic solutions)

Meanwhile, early forms of genetic testing which began in the 1950's involved counting the number of chromosomes per cell. Deviations from the expected number of chromosomes (46 in humans) could lead to a diagnosis of certain genetic conditions such as trisomy 21 (Down syndrome) or monosomy X (Turner syndrome)....Genetic tests are performed on a sample of blood, hair, skin, amniotic fluid (the fluid that surrounds a fetus during pregnancy), or other tissue.  [0]

In the spring of 2019, our network of immuno-oncologists have alerted us of a new advancement in cancer detection and genetic sequencing. The treatment community expressed enthusiasm over this "GRAIL" protocol in overwhelming comparison to the technologies available in the current market. [1] 

MedTech Review:
GRAIL EXPLAINED

Where the vast majority of cancer pursue the general presence of cancer, GRAIL's screening approach under the Galleri™ program offers a multi-cancer early detection test that promises to "detect over 50 types of cancers... over 45 of which lack recommended screening today — with a low false positive rate, through a single blood draw... GRAIL unique methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin."

“Today, the majority of cancers are found too late, when outcomes are often fatal, because most deadly cancers have no available screening tests,” says Josh Ofman, GRAIL CMO. “Current guideline-recommended screenings are critical, but in the United States they cover only five cancers and screen for a single cancer at a time.” [2]

By spring of 2020, news of GRAIL going public with investors like Johnson & Johnson, Arch Venture Partners and Amazon CEO Jeff Bezos. In fall of that same year, it was announced GRAIL would be acquired by Illumina, the company it was originally spun out from to pursue the development of its early detection technology. Other pharmaceutical companies such as Amgen, AstraZeneca, and Bristol Myers Squibb have also joined the growing list of partners.. [3]

An advancing movement in Multi-Cancer Early Detection (MCED) offers use of sophisticated technologies to identify signals of early cancer in blood and can detect a variety of cancers, many of which are potentially lethal and currently have no recommended screening tests. The ease and convenience of cancer detection via a single blood draw is an important added advantage that could help achieve better compliance than existing single-cancer screening tests. Still, the goal is not to have an MCED test replace the current cancer screening paradigm, but rather to complement existing single-cancer screening tests. (source- AJMC link)

• In a comparative response study, an MCED test identified a diversity of cancer signals with high specificity.

• The MCED test predicted the origin of the cancer signal with high accuracy across multiple cancer types.

• Results support the use of this MCED test on a population scale as a complement to existing single-cancer screening tests.

In this pre-specified, large-scale, clinical sub-study, the MCED test demonstrated high specificity and accuracy of CSO prediction and detected cancer signals across a wide diversity of cancers. These results support the feasibility of this blood-based MCED test as a complement to existing single-cancer screening tests. (source: Annals of Oncology link)

ROBERT L. BARD, MD, PC, DABR, FASLMS   -  Dr. Bard received the 2020 nationally acclaimed Ellis Island Award for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, Sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram  are safe, noninvasive, and do not use ionizing radiation.

GRAIL 101: THE NEXT GENERATION OF GENETIC DIAGNOSTICS & CANCER TRACKING (Transcript from GRAIL educational video)  Cancer strikes one in two men and one in three women during their lifetimes and most cancers are detected too late. Often when the prognosis is poor and treatment options are limited, nearly 80% of those diagnosed with late stage cancer die within five years. If the cancer could be discovered earlier, prognosis could improve and treatment options could expand because only a few cancers are screened for many cancers can often grow undiscovered for years. In fact, 71% of cancer deaths are due to cancers with no recommended screening test. But what if there was a way to screen for multiple cancer types, with something as simple as a routine blood test inside every human body DNA fragments are routinely released from cells and circulate within our blood. These fragments often contain features that indicate the type of cell they originally came from including cancer cells. After extensive research grail determined the most promising way to detect cancer signals from this DNA in the blood and where in the body. These signals came from by looking at one type of unique feature of DNA, methylation markers, grails, DNA sequencing, and machine learning technology allows us to recognize signatures for cancer by analyzing over 1 million of these potential methylation sites in the DNA fragments found in the blood. And after comparing thousands of cancer, patient blood samples with cancer free samples, we identified the ability to predict the presence of cancer. Recognizing this signature allows braille to determine whether cancer may be present. And if a cancer is present to detect its location within the body with high accuracy, with larger and more diverse datasets grail has continually improved the ability to predict when cancer is present and now has a validated multi cancer early detection test available to healthcare providers. The gallery test is complimentary to current cancer screening approaches and detects over 50 types of cancer. 45 of which have no recommended screening test today using a simple blood draw gallery detects cancers and healthcare providers can direct actionable next steps to confirm the diagnosis. Even before cancer has had a chance to spread early cancer detection has the potential to improve cancer survival because beating cancer starts with knowing you have it. Grail early detection for multiple cancers. The gallery test is not detect all cancers. It should be used in addition to routine screening tests, false positives and false negatives can occur. The test is available by prescription only.

THE 20TH ANNIVERSARY OF 9/11: MEMORIALIZED IN IMAGES

The NY Cancer Resource Alliance, the F.A.C.E.S. Foundation and MOVEMBER hosts the 20th Anniversary of the 9/11 attacks with a special NYCRA-NEWS memorial issue. We proudly feature the powerful and most compelling images of world recognized photographer ANDREA BOOHER - film producer and photojournalist. Ms. Booher has worked as a documentarian for twenty-six years. Based in Colorado, her assignments have taken her to East Africa, Latin America, Micronesia, India, Antarctica, Australia, Myanmar, Somalia, Mexico and Haiti. In the last two decades she has photo-documented every major disaster in the United States, Trust Territories and Sovereign Nations for the Federal Emergency Management Agency (FEMA). Her documentary work resides in several permanent collections, including the National Archives and the Smithsonian. In 2001, she spent 10 weeks working at Ground Zero in the immediate aftermath of the World Trade Center attack. She was one of two photographers working for FEMA with unlimited access. Her work from 9-11 has been published in magazines, newspapers and documentaries worldwide. She was personally profiled on A&E, The History Channel, CNN, Camera Arts, NPR and Photo District News. (see video: "A Return to Zero")

FIRST RESPONDERS DEMAND EARLY SCREENING:
by Lt. Chris Conner/ Bedford (TX) Fire Dept. 

Roughly 7 years ago, my partners and I launched F.A.C.E.S. (Firefighters Against Cancer & Exposures 501c3) and part of our mission was to support the standardization of affordable repeat genetic testing in firehouses nationwide.  We reviewed a wide list of tests for their efficacy and accessibility.  We were attracted to a few strategies for early detection, and for the money, they served their purpose of altering that a simple blood test told you that you 'may' have cancer.  This did not say where, or how aggressive or how it affected you- but the technology at the time was 'state of the art' for its ability to tell you that you had a problem somewhere, and it was up to further testing to dig in and find it (and treat it, of course).

My commitment to reporting cancer diagnostic solutions to the fire service stems from the undisputed fact that we hold a high level of occupational risks from exposures, whereby finding the latest information about new tools ASAP can save someone's life out there.  Hence, learning about GRAIL and how genetic sequencing works, and specifically the ground-breaking improvements they offer the patient community could support our goals of prevention, early detection and accurate monitoring.  

As with all medical innovations, regulatory approval and public confidence comes from through repeat clinical trials. I found it impressive that they have been 'polishing' their data for many years before deploying them publicly (see their early Pathfinder study, their Cell-free Genome Atlas Study,  and their concept of a Multi-Cancer Early Detection (MCED) - with over 130,000 enrolled study.  The MCED expanded their scope of identifying the cancer type(s), leading the next stage and direction in testing. If companies like GRAIL keeps up this level of focus and quality research, perhaps someday, fast, accurate regular screening and early readings can be part of our life-saving standard.

ABOUT THE AUTHOR

CHRISTOPHER R. CONNER - Fire Lieutenant/Paramedic at Bedford FD
As a career firefighter, I personally knew the risks of the job and accepted them if it meant helping others. Early in my career, firefighters that I worked with were getting cancer and losing their battles. I didn't have a full understanding why firefighters were getting cancer until one of my mentors in the fire service was diagnosed. Unfortunately, Keith did not overcome his battle with cancer and it became a personal mission for me to help other firefighters. I learned firsthand that cancer is not just a disease that affects the individual, but it also has affects on families and friends. I have initiated and proposed many cancer preventive policies in the fire service. Additionally, I created a non-profit organization to assist firefighters that are diagnosed with cancer.

REFERENCES:

00) PMC/ "Mammography: a history of success and scientific enthusiasm" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4337127/

0) Genetic testing /Wikipedia: https://en.wikipedia.org/wiki/Genetic_testing

1) GRAIL’s multi-cancer early detection test: https://grail.com/our-products/

2) AAAS/ Science magazine- TECHNOLOGY FEATURE "Catching cancer extremely early"- By Mike May/ Mar. 26, 2021 : https://www.sciencemag.org/features/2021/03/catching-cancer-extremely-early#:~:text=The%20scientists%20reported%3A%20%E2%80%9CPanSeer%20detects,of%20care%E2%80%9D%20(2)

3) Healthline: "Galleri is gathering widespread support" by Jamie Reno on March 17, 2021:  https://www.healthline.com/health-news/this-new-test-can-detect-50-types-of-cancer-from-a-single-blood-draw#Galleri-is-gathering-widespread-support