Understanding FDA not Cleared for Bipolar Disorder

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Despite the prevalence of empirical practice, evidence supporting the use of transcranial magnetic stimulation (TMS) in treating Bipolar Depression (BD) is sparse compared to that for unipolar Depression. 


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


However, a highly relevant article that discusses Deep TMS for Bipolar Disorder (BD) is  https://www.sciencedirect.com/science/article/pii/S240584402403319X.


Important note for use:

This blog post discusses Deep TMS Treatment for Bipolar Disorder. While TMS devices are FDA-cleared for certain conditions, the information herein regarding Deep TMS for Bipolar Disorder is NOT intended for individuals in the United States as it includes treatment applications that HAVE NOT BEEN FULLY CLEARED by the FDA (U.S. Food and Drug Administration) for safety and efficacy for the full spectrum of bipolar disorder in the U.S. Please read on for crucial details regarding its current regulatory status.


Bipolar Disorder, sometimes referred to as manic-depressive illness, is a complex brain condition.

This condition affects a substantial portion of the adult population, with millions of individuals experiencing it each year. 


For instance, about 2.6 percent of American adults aged 18 and older are estimated to have bipolar disorder in any given year. 


Similar to chronic illnesses such as diabetes or heart disease, Bipolar Disorder requires ongoing management throughout a person's life. 

Given its association with the brain's reward system, innovative treatments targeting prefrontal regions and related neural networks, such as Deep Transcranial Magnetic Stimulation (Deep TMS™), are continuously being explored for their potential effectiveness in managing this chronic condition.


A previous clinical trial reported by BrainsWay indicated that their treatment was well-tolerated by all subjects, with a clinical response achieved in 70% of subjects (of whom a vast majority displayed significant improvement) compared with previous antidepressant treatments given to those subjects.



Specifically concerning remission, some studies focusing on TMS for Bipolar Depression have shown promising results.


An analysis of participants undergoing 25 or more TMS sessions for Bipolar Depression found that 41% achieved remission, defined as little-to-no depressive symptoms.


Another study involving a rapid-acting TMS protocol reported 40% remission rates immediately after a short course of treatment, which further grew to 60% one month post-treatment. 


The risk of triggering manic episodes with TMS is considered low, comparable to that of some antidepressant medications..


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



 In summary, when compared to traditional treatment modalities for bipolar disorder, deep TMS offers a unique advantage. 

It is non-invasive, does not require medication, and has minimal side effects, making it an attractive option for individuals who have not responded well to other treatments or prefer alternative approaches. 




References

Neurodivergent Insights. DSM 5 Bipolar 2 Disorder Criteria. 

Psychology Today. How Common Is Recovery From Bipolar Disorder? 

Evaluating the Efficacy of Deep TMS for Bipolar Disorder