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NCT07127913 · ClinicalTrials.gov registry record · NA
Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
A NA study of Bipolar II Disorder and Bipolar II Disorder, Most Recent Episode Major Depressive, sponsored by Andrew Krystal.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07127913 is a NA study of Bipolar II Disorder and Bipolar II Disorder, Most Recent Episode Major Depressive that is actively recruiting participants, run by Andrew Krystal. The registered enrollment target is 10 participants, below the 87-participant average among 13 other Bipolar II Disorder trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07127913, a NA study of Bipolar II Disorder and Bipolar II Disorder, Most Recent Episode Major Depressive, is actively recruiting participants, sponsored by Andrew Krystal.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE Device: Stimulation-ON
- DEVICE Device: Stimulation-OFF
- DEVICE Device: Stimulation -ON Active Control
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-07-16 |
| Est. Completion | 2035-06-28 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07127913
The ClinicalTrials.gov registry entry for NCT07127913 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 87-participant average among 13 other Bipolar II Disorder trials with a reported enrollment target (89% lower). The listed sponsor is Andrew Krystal, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bipolar II Disorder appearing as the primary indexed condition, and to 3 interventions - of which Device: Stimulation-ON is the first listed.
NCT07127913 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT07127913 about?
NCT07127913 is a clinical study titled "Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression". 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 he...
What is the current status of trial NCT07127913?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2025-07-16. Estimated completion is 2035-06-28.
What conditions does trial NCT07127913 study?
This clinical trial studies the following conditions: Bipolar II Disorder, Bipolar II Disorder, Most Recent Episode Major Depressive.
What interventions are being tested in trial NCT07127913?
The interventions under investigation include: Device: Stimulation-ON (DEVICE), Device: Stimulation-OFF (DEVICE), Device: Stimulation -ON Active Control (DEVICE).
Who is sponsoring clinical trial NCT07127913?
This trial is sponsored by Andrew Krystal, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07127913 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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