TMS Vendors Seek Out New Indications and Markets

by James Cavuoto, editor

February 2020 issue

The market for transcranial magnetic stimulation systems, which is currently driven largely by devices that treat treatment-resistant depression, is likely to expand in the years ahead as manufacturers and investigators devise new therapeutic applications. TMS is currently approved by the FDA to treat major depression and obsessive compulsive disorder.

Earlier this month, BrainsWay Ltd. announced results from a randomized controlled double-blind clinical trial assessing the safety and efficacy of the company’s deep TMS system for the treatment of adults with ADHD. Researchers at Tel Aviv Sourasky Medical Center, Tel Aviv University, Ben Gurion University, and BrainsWay conducted the study, which used fMRI to assess the effect of dTMS on clinical, cognitive, and neural activity in adults with ADHD. Results showed a statistically significant improvement in patient-reported assessments of inattention, together with a significant increase in activity that was observed within the dorsolateral prefrontal cortex, a part of the brain previously shown to have reduced activity in adults with ADHD.

“Reduced activity of the DLPFC, a brain region that controls the ability to respond to changing attentional demands, has previously been observed in patients with ADHD,” said Maya Bleich-Cohen, senior investigator at Tel Aviv Sourasky Medical Center and an investigator on the study. “The results of this initial study indicate that dTMS can be effective in modulating the DLPFC and that this may be a feasible technique to improve attention symptoms in adults with ADHD. Additional study of this noninvasive treatment approach in this population is warranted.”

Last year, the company reported positive results from a pivotal multicenter trial assessing dTMS as an aid in smoking cessation in adults suffering from chronic smoking addiction. But BrainsWay chose to discontinue funding of a study of dTMS for treating PTSD, citing insufficient efficacy.

At the 2019 Military Health System Research Symposium, investigators from the Uniformed Services University of the Health Sciences presented clinical data from a trial of Neuronetics’ NeuroStar system for PTSD and TBI. They also presented a case report of one patient treated and studied for Alzheimer’s Disease.

A newly published literature review in Current Neurology and Neuroscience Reports highlights the compelling scientific and clinical data supporting further studies into the use of TMS to treat a broader range of common neurological conditions, including stroke, acute migraines, and dementia. According to the article, there are 1,641 studies underway using TMS to treat a broad array of other neurological disorders, including more than 60 trials alone studying the effects of TMS to diminish or reverse the effects of early dementia. The most promising results are in the treatment of acute migraines and primary progressive aphasia, and the effects of stroke.

“TMS can work as a stimulant or an inhibitor of cerebral activity, or both,” said Antonio Iglesias, a neurologist at Loyola University and author of the article. In addition, different sized coils and varying magnetic impulses can impact outcomes, depending on a patient’s neuroplasticity. “Most importantly, TMS is well-tolerated by most patients with few side effects,” said Iglesias.

“TMS has now opened the field of neurology in multiple areas,” said Iglesias. “And, there are many variables that could be studied and arranged to improve brain functionality and network connections.”

      

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