Neuroelectrics Announces Results of Telemedicine Pilot Depression Study with Starstim tDCS Therapy

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Neuroelectrics Corp. announced today study results published to the preprint server medRxiv that suggest tele-supervised at-home transcranial direct current stimulation (tDCS) using Starstim over the left dorsolateral prefrontal cortex (L-DLPFC) may improve the clinical symptoms of major depressive disorder (MDD).

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Individual wearing Starstim device. Photo credit: Neuroelectrics

The preprint, titled “Multichannel tDCS with Advanced Targeting for Major Depressive Disorder: A Tele-Supervised At-Home Pilot Study,” highlights results from a multicenter, open-label feasibility telemedicine pilot study that studied the efficacy, safety, and feasibility of home-based tDCS using Starstim to target the L-DLPFC. The results suggest it represents a promising avenue for managing depression. Starstim is intended to be a complementary therapy to medication and an alternative to invasive brain stimulation (i.e., deep brain stimulation), which requires precise placement of electrodes in targeted areas deep within the brain.

The study was conducted across multiple centers and involved 35 participants diagnosed with medication-resistant MDD to evaluate tDCS administered at home using Neuroelectrics’ Starstim device. Throughout an eight-week period, participants underwent 37 sessions of multichannel at-home tDCS in a unique, entirely virtual study where all interactions and visits occurred remotely, with each tDCS session lasting 30 minutes. The stimulation targeted the L-DLPFC, a brain area that is a critical node in the brain circuit associated with the regulation of mood and shown to play a causal role in the pathophysiology of depression. To ensure a tailored approach for each participant group, the study incorporated cutting-edge computational models to optimize the multichannel stimulation montage and tailor it to the participant group.

The primary efficacy measure for this study was the median percent change in the Montgomery-Asberg Depression Mood Rating (MADRS) from the baseline to the end of the 4-week follow-up period after treatment completion.

Study Results

Results from this study highlight the safety and feasibility of at-home tDCS, with nearly 90% of participants completing the treatment without experiencing any adverse effects. Notably, the study observed a 64% median percentage reduction in observer-rated MADRS scores, indicating a significant alleviation in depressive symptoms. Over 70% of participants demonstrated a ≥50% improvement in MADRS scores, with a robust response rate of 73%.

Secondary measures, including the Quick Inventory of Depressive Symptomatology-Self Report (QUIDS-SR) and the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), also showed significant enhancements, underscoring the effectiveness of tDCS in reducing depressive symptoms.

“We’re excited to announce the results of our telemedicine pilot study, showcasing the transformative potential of at-home tDCS therapy with our Starstim device in managing MDD,” said Ana Maiques, CEO & Co-Founder, Neuroelectrics. “With nearly 90% of participants completing treatment without adverse effects and a 64% median reduction in depressive symptoms, Starstim is a promising option for individuals with MDD who have not found relief through traditional pharmacologic therapies. These results mark a significant step forward in enhancing accessibility and improving treatment outcomes for patients with MDD.”

“These results validate the potential of remote, at-home, properly planned and remotely supervised and supported tDCS therapy with the Neuroelectrics’ Starstim device as a highly promising treatment option for individuals with major depressive disorder who have not responded to pharmacologic therapies,” said Alvaro Pascual-Leone, M.D., Ph.D., Professor of Neurology, Harvard Medical School. “These results support future controlled clinical studies, offering hope for improved treatment outcomes and enhanced accessibility for patients.”

In collaboration with Michael Nitsche’s team in Dortmund, Germany, Neuroelectrics also recently co-authored a pre-print titled Optimized multichannel tDCS protocol for clinical use in patients with major depressive disorder: A randomized, controlled trial, which highlights the potential of optimized stimulation protocol to treat depression using Starstim in a three-arm study comparing optimized versus sham or traditional montages. The results of the two studies are consistent regarding efficacy in the active, multichannel arm.

About Neuroelectrics

Neuroelectrics is developing a therapeutic platform that uses neuromodulation for the treatment of a range of neurological and psychiatric disorders. The platform combines safe and proven neuromodulation capabilities with remote-controlled delivery and personalized treatment protocols developed using computational methods to restore and maintain brain health. Based in Cambridge, Massachusetts, and Barcelona, Neuroelectrics has an expanding pipeline of computationally driven solutions for neurologic and psychiatric diseases. Visit www.neuroelectrics.com.

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