US-based Motif Neurotech has received approval from the Food and Drug Administration (FDA) to begin the first clinical trial of its DOT implant. The device, about the size of a blueberry, is placed in the skull bone over a brain region proven to be a target for reducing depression symptoms. It does not come into direct contact with brain tissue. The procedure takes roughly 20 minutes and is performed on an outpatient basis.
The system is powered wirelessly and could eventually track brain signals to enable personalised therapy.
The RESONATE trial is designed for patients who have not responded to at least two courses of medication. There are approximately 3 million such individuals in the United States, suffering from so-called treatment-resistant depression, a leading cause of disability and suicide. Participants will be followed for 12 months at eight leading institutions, including Baylor College of Medicine, Mass General Brigham and NYU.
Motif Neurotech was founded just four years ago, a record time for reaching clinical trials among developers of implantable brain-computer interface (BCI) devices. If safety is confirmed, the technology could eventually be used for bipolar disorder, obsessive-compulsive disorder (OCD), Alzheimer’s disease and addiction.
The brain implant market is growing rapidly. Elon Musk’s Neuralink raised an additional $650 million in 2025. The startup is already conducting clinical trials of a chip that processes neural signals and transmits them to computers or phones. Five patients with severe paralysis are using the technology to control devices with their thoughts.
In May 2025, the FDA granted “breakthrough device” designation to Neuralink’s speech-restoration implant (the company’s vision implant, Blindsight, had previously received the same status). However, Neuralink is facing increased scrutiny: since December 2024, the Securities and Exchange Commission (SEC) has been investigating whether Musk misled investors about the implant’s safety.
