A Brain Implant for Depression Is About to Be Tested in Humans

The latest brain-computer interface could help people recover from severe depression. Motif Neurotech announced Monday that the US Food and Drug Administration has approved a human study to trial the company's blueberry-sized brain implant that sits in the skull and delivers electrical stimulation to treat depression.

The Houston-based startup, founded in 2022, is part of a budding industry pursuing technology to read and interpret brain signals. While other companies exploring similar technology, like Elon Musk’s Neuralink, Paradromics, and Synchron, are developing devices to enable paralyzed people to communicate and use computers, Motif is aiming to ease depression in people who have not benefited from medication.

The company’s device is implanted in the skull just above the dura, the brain’s protective membrane. It targets the central executive network, a part of the brain that is responsible for high-level cognitive functions and is underactive in major depressive disorder. The implant emits specific patterns of stimulation to turn “on” this network.

Motif’s device would allow patients to receive therapeutic brain stimulation at home. “Through frequent electrical stimulation, we think we can drive that neuroplasticity that creates stronger connectivity within the central executive network for patients with depression, so that they can get out of bed in the morning, call their friends, go to the gym,” says Jacob Robinson, Motif’s cofounder and CEO.

Electrical stimulation has been used for decades to treat depression, and Motif’s approach is just the latest iteration. Electroconvulsive or “shock” therapy began in the 1930s and is still used today in cases where patients don’t benefit from antidepressants. Deep brain stimulation, which involves surgically implanting electrodes into the brain, is occasionally used experimentally but is not FDA approved. A much milder form of stimulation known as transcranial magnetic stimulation, or TMS, was approved in 2008. While it can be highly effective, it typically requires a lengthy treatment regimen of five treatments a week for six weeks.

A study from 2021 found that during a 12-month period in the United States, nearly 9 million adults were undergoing treatment for major depressive disorder, and of those, almost 3 million were considered to have treatment-resistant depression, when symptoms do not improve after at least two, and often more, antidepressant medications.

Motif’s device can be implanted in a 20-minute outpatient procedure without the need for brain surgery. It’s powered by wireless magnetoelectric technology that Robinson developed while at Rice University and is charged with a baseball cap that patients will wear when receiving the stimulation.

The cap components send data on a patient’s prescribed dose of stimulation to their implant so that they receive a set amount of treatment. Robinson says patients will likely wear the hat for periods of 10 to 20 minutes several times over the course of a day, at least in the initial days of treatment.

“Our expectation is that people will begin to show response and even potentially go into remission within the first 10 days of therapy,” Robinson says. After that, patients would wear the cap less frequently for maintenance doses of stimulation.

The primary goal of Motif’s trial is to confirm the safety of the implant procedure and device over a 12-month period. Researchers will also track whether patients experience meaningful reductions in depression symptoms, and monitor quality of life, anxiety, and cognitive function over the course of the year. The study will enroll around 10 participants, the company says.

Robinson says future versions of Motif’s device will be able to record and monitor brain activity over time so that doctors will eventually be able to prescribe more personalized stimulation to patients.

“One of the things that makes psychiatry today so challenging is that we don't have an objective measure of a patient's well being,” he says. “Imagine trying to manage diabetes just based on how you're feeling. That's the state of psychiatry today. We lack these longitudinal recordings of what's happening in the organ that we care about, which is the brain.”