FDA lets Motif Neurotech start trial of a blueberry-sized implant for depression
The RESONATE study will test Motif's wirelessly powered stimulator, which sits in the skull above the brain, in people with treatment-resistant depression.
Houston-based Motif Neurotech has received FDA approval (an investigational device exemption) to begin its first clinical trial. The RESONATE early feasibility study will test the company’s implant in adults with treatment-resistant depression, meaning depression that hasn’t improved after multiple treatments.
The device
Motif’s implant, called DOT, is about the size of a blueberry. Surgeons place it in the skull, above the protective membrane over the brain (the dura), so it does not penetrate brain tissue. It has no implanted battery or wires; a wearable powers it wirelessly. The company says it is designed for a short outpatient procedure, and it delivers programmable electrical stimulation to a brain region linked to depression.
According to Motif, the study will run at multiple US medical centers, including Baylor College of Medicine and Mass General Brigham.
Why it matters
Deep brain stimulation has shown promise for severe depression, but it requires placing leads deep in the brain. Motif’s approach aims for a much less invasive option that could be used more widely if it proves safe and effective. An early feasibility study focuses mainly on safety, so efficacy results will take longer.
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