Understanding FDA not Cleared for Alzheimer Syndrome

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It profoundly impacts essential brain functions, leading to significant challenges with working memory, language skills, executive functions, attention, and long-term memory.

This progressive disease is marked by a gradual worsening of both cognitive abilities and overall functional capacity. 


In its initial stages, individuals may find complex tasks like driving difficult, experience short-term memory lapses, and occasionally exhibit behavioral changes such such as anger or aggressiveness.


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://www.brainsway.com/knowledge-center/benefits-of-deep-transcranial-magnetic-stimulationin-alzheimer-disease-case-series/ 



Important Note for Use

As indicated, Deep TMS treatment for Alzheimer's Disease is not intended for individuals in the United States as it HAS NOT BEEN FULLY CLEARED by the FDA for safety and efficacy for this specific indication. 



A BrainsWay safety study conducted on healthy individuals indicated that Deep TMS therapy, unlike standard TMS, had a positive impact on spatial memory in several standard tasks. 


These observed positive effects occurred after Deep TMS Therapy was applied to deep prefrontal cortical regions. 


As the disease advances, it commonly leads to dementia, which is a defining characteristic of Alzheimer's and other chronic brain conditions. 


Studies show significant improvements in global cognitive function, memory, language, and executive functions. One recent Phase II trial even reported a 52% reduction in cognitive decline over 52 weeks with TMS, and 96% improvement in daily living activities (reducing loss of independence). 



Beyond slowing progression, patients may experience improvements in memory, language skills, and overall global cognitive function. Deep TMS also offers the advantage of being generally well-tolerated, avoiding the systemic side effects common with pharmaceutical interventions. 



This often occurs when as much as 70% of the patient's brain cells have already sustained damage. 

This delay happens because the brain often manages to maintain normal function even with extensive neural damage, meaning neither the affected individual nor their family may detect a problem until the disease is considerably more advanced.



Deep Transcranial Magnetic Stimulation (Deep TMS) is emerging as a powerful, non-invasive treatment offering renewed hope in this regard. 


For those facing Alzheimer's Disease, the concept of remission shifts from a complete cure to achieving significant and sustained periods of cognitive improvement and stabilized functional abilities. 


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



In summary, Alzheimer's disease is a debilitating condition causing severe cognitive decline, often diagnosed late due to the brain's compensatory abilities.  innovative approaches like Deep TMS are being explored. Deep TMS, with its ability to stimulate deep brain regions, shows promise in improving cognitive functions like spatial memory.

 


References

 

https://www.brainsway.com/knowledge-center/benefits-of-deep-transcranial-magnetic-stimulationin-alzheimer-disease-case-series/