Almost one-third of adults with severe depression saw full remission of their symptoms using a prescription brain neuromodulation therapy device at home, a study found.

In January the FDA approved ProlivRx, a headset that noninvasively stimulates nerves in both the forehead (trigeminal nerve) and back of the head (occipital nerve), so that the electrical pulses converge on areas of the brain linked to mood disorders.

A double-blind, multicenter clinical trial found that the therapy was safe and effective in people who had not responded to antidepressant medication. Principal investigator Linda Carpenter, MD, a professor of psychiatry and human behavior at Brown, says the headset will expand access to an evidence-based treatment “beyond the walls of the specialty clinic.”

“Until now, patients struggling with difficult-to-treat depression did not have a non-pharmacological therapy option that could be administered at home,” says Carpenter, the chief of the Mood Disorders Program at Butler Hospital. “Even though there is a tremendous need for new treatment approaches when antidepressant medications aren’t working, access to interventional psychiatry services like transcranial magnetic stimulation remains limited.”

Participants in the randomized, controlled trial used ProlivRx at home over eight weeks. Of those with severe depression at the start of the trial who received active treatment, 21 percent reached full remission, according to the study published in the journal Brain Stimulation, compared to 6 percent of those receiving a very mild placebo stimulation.

After another eight weeks in which both groups had active treatment, 32 percent of the active-treatment group reached full remission. Furthermore, participants saw significant decreases in depression severity: 81 percent had “severe” or “very severe” depression at baseline, while only 15 percent were “severe” after 16 weeks.

Carpenter, the director of the TMS Clinic at Butler, notes that people with treatment-resistant depression often have endured their symptoms for years. “This therapy has the potential to become an essential tool in the mental health treatment landscape,” she says.