Actively Recruiting
Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
Led by Andrew Krystal · Updated on 2025-08-17
10
Participants Needed
1
Research Sites
519 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 70 years
- Diagnosis of Bipolar II Disorder with a depressive episode lasting at least 1 year that is treatment resistant
- No manic or hypomanic episode in the last 2 years
- Taking a mood stabilizer (lithium >0.6 mEq/L or valproate >350 mM/L), an atypical antipsychotic, or both for at least 2 weeks at a stable dose
- Must continue anti-manic medication throughout the study unless medically necessary to stop
- Failed, could not tolerate, or declined electroconvulsive therapy (ECT) after medical advice
- Montgomery-Asberg Depression Rating Scale (MADRS) score greater than 26 at two baseline visits
- Ability to complete repeated major depression rating scales
- No expected changes in psychotropic medication regimen during 4 weeks before and during the study
- Willing and able to undergo invasive brain recording and stimulation procedures
- Willing and able to attend multiple research visits and participate in home research protocols
- Able to provide informed consent
- Able to speak and read English
You will not qualify if you...
- Diagnosis of psychotic disorder, eating disorder, panic disorder, posttraumatic stress disorder, obsessive compulsive disorder, tic disorder, or other psychiatric disorders except major depressive disorder or generalized anxiety disorder
- Generalized anxiety disorder is the primary diagnosis during the current depressive episode
- Active suicidal ideation with intent and plan
- Suicide attempt requiring hospitalization within the past 2 years
- Alcohol or substance abuse or dependence (excluding caffeine) within the past 6 months
- Personality disorder likely to affect compliance or safety
- Fibromyalgia or chronic fatigue syndrome
- Current condition requiring chronic narcotic use
- History of traumatic brain injury, other neurological disorders, or developmental delay
- History of seizures
- MRI within 1 year showing significant abnormalities
- Previous brain surgery involving ablation or deep brain stimulation
- Implanted hardware incompatible with MRI or study
- Major medical conditions increasing surgical risk including severe diabetes, organ failure, recent stroke, bleeding disorders, infections, brain lesions, unstable cardiovascular disease, immunocompromised state, or cancer with less than 5 years life expectancy
- Unable to stop anticoagulant or antiplatelet therapy safely for surgery
- Blood clotting disorders unless cleared by hematology
- Allergy or sensitivity to materials in the NeuroPace RNS System
- Living alone without caregiver support after hospital stay
- Unable to comply with study follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
A
Andrew Krystal, MD, MS
CONTACT
N
Natalie Becker, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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