Motif Neurotech, a brain-computer interface (BCI) company developing technologies for mental health, today announced the FDA has approved an Investigational Device Exemption (IDE) for the RESONATE Early Feasibility Study.
The trial will evaluate the Motif XCS System, a small wirelessly powered implant that delivers gentle electrical stimulation to a brain region clinically shown to reduce the symptoms of depression in adults who have not found relief from two or more medications. This IDE approval comes four years after the company’s founding.
The RESONATE study will be conducted at up to eight medical institutions: Baylor College of Medicine, Massachusetts General Brigham, Emory Healthcare, UT Health Houston, University of Iowa, University of Utah Health, New York University and Brain Health Consultants (Houston).
The study's primary goal is to confirm that the device and procedure are safe over a 12-month period following implantation. Researchers will also track whether patients experience meaningful reductions in depression symptoms using widely used clinical assessments, and monitor quality of life, anxiety, and cognitive function throughout the study.
The implant, known as the DOT, sits in the bone over the brain region that's been established as a target for depression treatment. The DOT, approximately the size of a blueberry, is wirelessly powered and designed to be implanted in a 20-minute outpatient procedure. This procedure is expected to make the Motif technology even safer than neural devices that contact brain tissue. The XCS system is also being developed to monitor brain signals so that patients and clinicians can have objective measures to guide more personalized therapy.
