Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

July 16, 2025

Primary Completion Date

June 28, 2030

Study Completion Date

June 28, 2035

Conditions
Bipolar II DisorderBipolar II Disorder, Most Recent Episode Major Depressive
Interventions
DEVICE

Device: Stimulation-ON

Active neurostimulation from the NeuroPace RNS® System triggered by a biomarker

DEVICE

Device: Stimulation-OFF

No neurostimulation from the NeuroPace RNS® System

DEVICE

Device: Stimulation -ON Active Control

Active neurostimulation from the NeuroPace RNS® System triggered with a fixed duty cycle

Trial Locations (1)

94143

RECRUITING

University of California, San Francisco, San Francisco

All Listed Sponsors
lead

Andrew Krystal

OTHER

NCT07127913 - Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression | Biotech Hunter | Biotech Hunter