Recruiting

Brain stimulation implant for severe bipolar depression

Plain-English translation of NCT06599099 on ClinicalTrials.gov ↗ · Source last updated January 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study is testing whether a device called the Medtronic Percept RC System — a surgically implanted brain stimulation implant — can reduce depression symptoms in people with bipolar disorder who have not gotten better with at least four different standard treatments. The device sends targeted electrical signals to specific areas of the brain that affect mood. Researchers will monitor how well the treatment works and whether turning it off temporarily changes your symptoms.

Many people with bipolar depression don't respond adequately to medications, therapy, or other standard treatments, leaving them without effective options. This trial is exploring whether this brain stimulation device can help those who have exhausted conventional approaches.

Do you qualify?

You likely qualify if…

you are between ages 22 and 64
you have been diagnosed with bipolar I disorder and are currently in a major depressive episode
your depression is severe (confirmed by specific rating scales)
you have tried at least four different evidence-based treatments for bipolar depression (including at least two FDA-approved medications) without success, with at least two failed treatments during your current episode
your first manic or depressive episode occurred before age 40
you are on a stable dose of bipolar medications for at least four weeks and are willing to identify a trusted family member or friend to support your participation

You likely don't qualify if…

you have a history of schizophrenia, schizoaffective disorder, or psychotic symptoms outside of bipolar mood episodes
you are currently in a manic, hypomanic, or rapid-cycling mood state
you have had a moderate or severe substance or alcohol use disorder in the past 12 months
you have serious medical conditions such as heart problems, kidney or liver disease, active infections, or neurological disorders like seizures
you are pregnant, breastfeeding, or planning to become pregnant in the next 24 months

What participation looks like

First, you'll undergo screening visits and evaluations over about one month, including interviews, mood assessments, and medical tests to confirm you're a good fit for the study. If approved, you'll have surgery to place the brain stimulation implant — a robotic procedure guided by detailed brain imaging to find the most effective location. After surgery, you'll have regular follow-up visits to monitor your mood, side effects, and how well the device is working. At 12 months, the device will be temporarily turned off for a blinded period to confirm that any improvement you've experienced is from the treatment itself.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(4 sites)

United States

Massachusetts General Hospital, Boston, Massachusetts

Baylor College of Medicine, Houston, Texas

Rice University, Houston, Texas

University of Washington, Seattle, Washington

View full record on ClinicalTrials.gov