Closed-Loop Deep Brain Stimulation for Major Depression

Part of paid clinical trials in San Francisco, California.

Sponsor
Andrew Krystal
Study ID
NCT04004169
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Stimulation-ON — DEVICE
    Active neurostimulation from the NeuroPace RNS® System triggered by a biomarker
  • Stimulation-OFF — DEVICE
    No neurostimulation from the NeuroPace RNS® System
  • Stimulation-ON Active Control — DEVICE
    Active neurostimulation from the NeuroPace RNS® System triggered by a sham biomarker

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 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 depression.

Key Dates

Start date
Jul 18, 2019
Status verified
Apr 2023
Primary completion
Jun 28, 2030
Completion
Jun 28, 2035

Study Design

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

Arms

  • Experimental: Arm 1: Intervention (stimulation ON)
    This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and Stimulation ON Active Control (sham biomarker) (arm 3) in random order. After 6 months of intervening therapy, this 3-period crossover study will be repeated.
  • Sham Comparator: Arm 2: Sham Control (stimulation OFF)
    This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and Stimulation ON Active Control (sham biomarker) (arm 3) in random order. After 6 months of intervening therapy, this 3-period crossover study will be repeated.
  • Active Comparator: Arm 3: Active Control (stimulation ON triggered by sham biomarker)
    This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1), stimulation OFF (arm 2), and stimulation ON Active Control (sham biomarker) (arm 3) in random order. After 6 months of intervening therapy, this 3-period crossover study will be repeated.

Primary Outcome Measure

change in MADRS score [ Time Frame: administered at baseline and every 2 weeks for the first 18 weeks of stage 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Katherine Scangos, MD, PhD
[email protected]
415-476-7439
Rebecca Martinez, MS
[email protected]
415- 476-7439
Katherine Scangos, MD, PhD (PRINCIPAL_INVESTIGATOR)
Andrew Krystal, MD, MS (PRINCIPAL_INVESTIGATOR)
Edward Chang, MD (SUB_INVESTIGATOR)
Philip Starr, MD (SUB_INVESTIGATOR)

Find similar trials in San Francisco, CA

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

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