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

NCT07127913 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-17

No results posted yet for this study

Summary

Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain.

The purpose of this study is to test a personalized approach to brain stimulation as an intervention for bipolar depression The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies.

The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat bipolar depression.

Conditions

  • Bipolar II Disorder
  • Bipolar 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

Sponsors & Collaborators

  • Andrew Krystal

    lead OTHER

Principal Investigators

  • Andrew Krystal, MD, MS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2030-06-28
Completion
2035-06-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07127913 on ClinicalTrials.gov