Motif Neurotech Earns FDA IDE for Study of Brain Implant for Depression

Motif Neurotech has received U.S. Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) for its RESONATE early feasibility study.

The trial will evaluate the company’s Motif XCS system, a small, wirelessly powered implant that delivers electrical stimulation to a brain region clinically demonstrated to reduce symptoms of depression in adults who haven’t gotten relief from two or more medications. The IDE comes four years after the company’s founding, making Motif the fastest implantable brain-computer interface (BCI) company to move from founding to IDE approval with a novel device.

The company said the Motif DOT XCS system was designed for both precision and practicality. The implant (known as the DOT) sits in the bone over the brain region established as a target for depression treatment. The DOT is about the size of a blueberry and designed for implantation in a 20-minute outpatient surgery.

The XCS system is also under development to monitor brain signals so patients and doctors can have objective measures to guide personalized therapy.

The RESONATE study will be conducted at up to eight leading 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).

“We founded Motif to build neural devices that give everyone suffering from a mental health condition the opportunity at a better life, “ said Motif Neurotech founder and CEO Jacob Robinson. I am incredibly proud of our team, and grateful for this opportunity to advance our mission.”

The study’s main goal is to confirm the device and procedure are safe over a 12-month period after implantation. Researchers will also track if patients have meaningful reductions in depression symptoms using clinical assessments, and monitor quality of life, anxiety, and cognitive function throughout the study.

“IDE approval is a critical milestone that allows us to move from development into the clinic, and we are proud to have earned it,” said Motif Neurotech COO Nick Halper, who led the company’s IDE submission. “The patients who will participate in RESONATE have exhausted existing treatment options and are putting their trust in us, and IDE approval from the FDA is confirmation of the care and rigor our team has put into our therapy.”

In February 2025, the company was granted a multi-million dollar award from U.K.’s Advanced Research and Invention Agency (ARIA) to develop its BCI technology.