Neurostimulation has been proven to help relieve symptoms of major depressive disorder—including otherwise difficult-to-treat cases of treatment-resistant depression, or TRD—though currently available technologies often require patients to either visit a clinic for regular therapy sessions or undergo open-brain surgery to have a neurostim device implanted.
Motif Neurotech is aiming to switch up that pattern: Its own neuromodulation implant is designed to deliver its therapy from the comfort of a patient’s own home while also eliminating the need for any especially invasive or risky surgical procedures.
The device has yet to receive regulatory clearance—let alone undergo a comprehensive clinical trial—but results of a first-in-human study published before peer review on preprint server medRxiv on Friday suggest that it could indeed offer a safe, minimally invasive approach to using neurostimulation to treat severe depression.
The DOT device, named for its status as a digitally programmable over-brain therapeutic, measures only about one centimeter across. It doesn’t connect to any leads nor does it contain a battery. Instead, a separate magnetic coil and driver system wirelessly sends both power and data to the implant, which in turn is housed within a glass enclosure that includes an electrode to deliver the stimulation.
Motif is particularly proud of the fact that the tiny, wireless device doesn’t need to come into contact with the brain or its protective dura at all. It’s merely placed in a 14-millimeter burr hole in the skull—in a minimally invasive outpatient procedure that, according to the company, takes only about 20 minutes—from which it can target specific areas of the brain.
Ultimately, the company plans to build out its neuromodulation technology into an at-home treatment system that would connect a wearable headset to the DOT implant for regular sessions with the so-called “brain pacemaker.”
“This tiny device, which cannot be seen once implanted, provides at-home stimulation that engages brain networks known to treat depression. This is the same brain area activated by transcranial magnetic stimulation, which is proven to treat TRD but requires frequent clinic visits and usually only provides temporary relief,” Sameer Sheth, M.D., Ph.D., a neurosurgeon and Motif’s co-founder, said in a company announcement Monday. “This new at-home-based therapy has the potential to revolutionize the treatment options for patients with depression.”
The study—which was conducted at Baylor St. Luke’s Medical Center in Houston and led by researchers from the Baylor College of Medicine, Rice University and UTHealth Houston—proved that the DOT device could be safely implanted in patients’ skulls and, from there, successfully reach the designated areas of the brain to deliver neurostim therapy.
The researchers also performed a longer-term study of the implant. Though that monthlong observation was conducted in large animals rather than in humans, it too showed that the device could consistently provide safe and effective brain stimulation.
“With our technology, a short outpatient procedure will enable long-lasting therapy with very few side effects compared to drugs,” Jacob Robinson, Ph.D., Motif’s CEO and founder, said in the release. “The growing trend of increasing efficacy and reduced invasiveness may soon make neuromodulation to treat mental health as common as pacemakers in cardiology.”