Soterix Medical today released results from trials of its direct current stimulation-limited total energy technology designed to treat depression, touting that the device was found to be safe and effective with improvements in depression-rating metrics lasting for a month after treatment.
The tDCS-LTE system is designed to deliver energy to the dorsolateral prefrontal cortex region of the brain which is implicated in depression control, the New York-based company said.
In the first trial, the company reported that its tDCS-LTE system was effective and safe as an add-on intervention for patients with type I or II bipolar disorder during major depressive episodes who are being treated with pharmaceuticals.
Data from the 59-patient trial indicated that treatment with the system resulted in a 14-point improvement in the Hamilton Depression Rating scale after 12 treatments, with benefits persisting for over a month. Side effects were found to be no different from placebo, the company added.
Results from the first trial were published in the journal JAMA Psychiatry.
In the second trial, which enrolled 245 patients, researchers reported that treatment with the tDCS-LTE was superior to placebo, resulting in an 8 point improvement on the HDR scale after 15 weekday treatments followed by seven tapered weekly treatments.
Patients treated with the tDCS-LTE group reported higher rates of itching, tingling, tinnitus and nervousness than other groups, while groups receiving only escitalopram had higher rates of sleeplessness and severe constipation.
Results also indicated that patients who received the tDCS-LTE treatment maintained significantly improved HDR scores compared to patients receiving placebo, while patients on escitalopram had slightly improved HDR scores and noted side effects.
Results from the second trial were published in the New England Journal of Medicine.
“We could not be more pleased with this series of controlled clinical trials. which validate Soterix Medical’s commitment to developing technologies that provide unique benefits to patients and physicians. These proven benefits of tDCS-LTE as an add-on to drug therapy or a stand-alone treatment reflect years of scientific research and optimization by Soterix Medical engineers and clinical partners around the world,” regulatory affairs VP Renato Moratore said in a prepared statement.
“There are two essential features of the Depression tDCS-LTE system that maximize efficacy through target engagement while simultaneously ensuring tolerability. The OLE electrode montage is optimized for DLPFC stimulation while the LTE power management ensures comfortable stimulation. These two controlled clinical trials confirm that the Soterix Medical tDCS-LTE system provides an unique and proprietary balance of effectiveness with minimal side-effects,” chief product manager Kamran Nazim said in a press release.
Last May, Soterix said it won FDA 510(k) clearance for its IontoDC device designed to use direct current to introduce ions of soluble salts and other drugs into the body.