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

Part of paid clinical trials in San Francisco, California.

Sponsor
Andrew Krystal
Study ID
NCT07127913
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Device: Stimulation-ON — DEVICE
    Active neurostimulation from the NeuroPace RNS® System triggered by a biomarker
  • Device: Stimulation-OFF — DEVICE
    No neurostimulation from the NeuroPace RNS® System
  • Device: Stimulation -ON Active Control — DEVICE
    Active neurostimulation from the NeuroPace RNS® System triggered with a fixed duty cycle

Study Details

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.

Key Dates

Start date
Jul 16, 2025
Status verified
Aug 2025
Primary completion
Jun 28, 2030
Completion
Jun 28, 2035

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Arm 1: Intervention (stimulation ON)
    This is a crossover trial. Each patient will receive 12 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and Stimulation ON Active Control (fixed intermittent) (arm 3) in random order.
  • Sham Comparator: Sham Comparator: Arm 2: Sham Control (stimulation OFF)
    This is a crossover trial. Each patient will receive 12 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and Stimulation ON Active Control (fixed intermittent) (arm 3) in random order.
  • Active Comparator: Active Comparator: Arm 3: Active Control (stimulation ON fixed intermittent)
    This is a crossover trial. Each patient will receive 12 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and Stimulation ON Active Control (fixed intermittent) (arm 3) in random order.

Primary Outcome Measure

Change in Montgomery-Asberg Depression Rating Scale (MADRS) score [ Time Frame: Administered twice at baseline and every 2 weeks for the 36-40 weeks of Stage 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Andrew Krystal, MD, MS
[email protected]
510-621-3193
Natalie Becker, BS
[email protected]
510-621-3193
Andrew Krystal, MD, MS (PRINCIPAL_INVESTIGATOR)
Edward Chang, MD (SUB_INVESTIGATOR)
Philip Starr, MD, PhD (SUB_INVESTIGATOR)
Kristin Sellers, PhD (SUB_INVESTIGATOR)
Ankit Khambhati, PhD (SUB_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California, San Francisco· San Francisco, CA

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