Soterix Medical announced today that it began patient recruitment for a trial of its treatment-resistant depression treatment.
The company intends to enroll individuals who received but did not adequately respond to repetitive Transcranial Magnetic Stimulation (rTMS).
Woodbridge, New Jersey-based Soterix, with technology licensed from Columbia University, develops a cloud-based targeting software. The system, based on parcel-guided rTMS, leverages anatomical MRI, machine learning and data. It aims to enable optimized, personalized rTMS therapy.
“Parcel-guided rTMS represents a major technical advance in rTMS therapy by combining three unique [Soterix] technologies,” said Dr. Abishek Datta, CEO and CTO of Soterix. “One, Soterix Medical provides the unique FDA-cleared navigation system, not interrupted by line-of-site issues. Two, Soterix Medical has developed seamless cloud-based systems for neuromodulation optimization. And three, the TMS targeting approach developed by Columbia University provides the key to delivering rTMS therapy optimized to each patient’s brain circuit.”
Conventional rTMS over the left dorsolateral prefrontal cortex represents one FDA-approved option for treatment-refractory depression. However, Soterix said it remains only partially effective. The company cited response and remission rates of approximately 41% and 35%, respectively.
A pilot study of parcel-guided rTMS led to a 100% treatment response. The patients in question demonstrated resistance to conventional rTMS therapy, Soterix said.
“We are excited for this next stage in the validation of parcel-guided rTMS therapy for depression. This trial is intended to confirm that personalized TMS delivery is crucial to deliver the fullest therapeutic value of TMS, to all patients, even those that did not respond adequately to conventional rTMS,” said Dr. Dennis Truong, scientist at Soterix Medical and principal investigator for the study.