Can brain implants read and treat bipolar depression without triggering mania?

NCT ID NCT07745374

Recruiting now Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study tests whether deep brain stimulation (DBS) can safely treat severe, treatment-resistant bipolar depression. The approach uses a brain implant that delivers stimulation and simultaneously monitors brain signals linked to depression and mania. The goal is to see if this real-time monitoring can guide therapy to ease depression while avoiding manic switches. The trial involves a small group of adults with bipolar I disorder who have been depressed for at least a year.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Deep brain stimulation (DBS) using the Medtronic Percept PC system, with continuous monitoring of brain signals from the subcallosal cingulate and amygdala.
What this could lead to: If successful, this could lead to a personalized brain-stimulation therapy for severe bipolar depression that adjusts in real time to prevent manic episodes.
What could go wrong: This is a very small early-stage study (5 people), so results may not apply broadly. DBS is invasive brain surgery and carries risks like infection, bleeding, or mood changes.

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar disorder bipolar I disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BIPOLAR DEPRESSION BIPOLAR I DISORDER

Contacts and locations

Locations

Center for Advanced Circuit Therapeutics, Clinical Neurosciences Center, Mount Sinai West
RECRUITING

New York, New York, 10019, United States

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