Understanding FDA not Cleared for Chronic Pain

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Chronic Pain, particularly in the form of neuropathy, affects a significant portion of the population. Neuropathy, a common condition, affects approximately 50% of individuals with long-standing diabetes. 

Among its various forms, symmetric distal sensorimotor polyneuropathy is particularly prevalent, with pain being a dominant and often debilitating symptom. 


While painful neuropathy can respond to certain medications like antidepressants, anticonvulsants, and opioid agonists, these drugs are frequently ineffective for many patients or can lead to severe and undesirable side effects. 


Therefore, this study aimed to conduct a retrospective observational analysis using TMS registry data to compare the efficacy of  TMS treatment for Chronic Pain and unipolar Depression. 


However, a highly relevant article that discusses Deep TMS for Chronic Pain is https://investors.brainsway.com/news-releases/news-release-details/brainsway-reports-promising-feasibility-data-showing-pain-reduction-with-deep-tms-therapy/



Important Note for Use

As detailed, Deep TMS Treatment for Chronic Pain and Neuropathy is not intended for individuals in the United States as it HAS NOT BEEN FULLY CLEARED by the FDA for safety and efficacy for these specific indications. 


Deep Transcranial Magnetic Stimulation (Deep TMS) presents a novel, non-invasive approach to managing  Chronic Pain.

Traditional TMS coils, such as the figure-of-eight coil, are limited to stimulating only superficial brain regions. 


Attempting to increase the stimulus intensity to reach deeper areas with these coils would significantly raise the risk of adverse effects.


BrainsWay's innovative H-coil technology, however, overcomes this limitation. It allows for deeper brain stimulation without substantially increasing the intensity of induced fields in superficial cortical regions. 



This unique capability is crucial as it enables the H-coil to effectively stimulate areas like the lower-limb motor cortex, which is tucked deep within the medial longitudinal fissure. This targeted, deeper stimulation offers a novel and promising approach to pain management.


Recent clinical research has begun to explore the potential of Deep TMS in treating neuropathic pain. One study specifically investigated the use of Deep TMS over the deeper leg motor cortex to treat patients experiencing diabetic neuropathic pain.



Deep TMS offers a critical pathway toward achieving these vital periods of well-being. 


This non-invasive treatment delivers substantial relief, with many patients experiencing a 30-50% reduction in pain symptoms. This translates into the potential for sustained periods of reduced pain that can significantly transform daily living. Deep TMS offers renewed hope for prolonged symptom control and an improved life, even for those previously resistant to therapy


Outside the U.S., BrainsWay Deep TMS Therapy for Chronic Pain and Neuropathy  has received regulatory approvals from the CE Mark (Conformité Européenne) in Europe and by ANIVISA (the Brazilian Health Regulatory Agency). 


In Summary, Chronic Pain, particularly neuropathic pain, poses a significant challenge for both patients and healthcare providers due to its debilitating nature and the limitations of conventional treatments. 

Deep TMS, with BrainsWay's innovative H-coil technology, offers a promising non-invasive alternative by enabling targeted stimulation of deeper brain regions. 



References


https://investors.brainsway.com/news-releases/news-release-details/brainsway-reports-promising-feasibility-data-showing-pain-reduction-with-deep-tms-therapy/