Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
This study is testing a personalized approach to treat severe depression in people with Bipolar II Disorder. Researchers will use a surgically implanted device called the NeuroPace RNS® System. This system measures your brain activity and then delivers small electrical pulses to help improve depression symptoms. The study aims to see if these changes in brain activity can reduce depression. You might be able to join if you are 22-70 years old, have Bipolar II Disorder with long-lasting, treatment-resistant depression, and are currently taking a mood stabilizer. The main way success will be measured is by looking at changes in your depression scores over 36-40 weeks.
- Study design
- This is a single-center study with 10 participants, designed in three stages to test the feasibility of personalized closed-loop stimulation.
- What's involved
- You would undergo two brain surgeries: one to identify treatment sites and a second to implant the NeuroPace RNS® System. You would have regular clinic visits for about 4-18 months, followed by 36-40 weeks where the device is turned on and off.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for measuring depression scores is at 36-40 weeks during Stage 3.
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NCT07127913
Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
Recruiting
NAAges 22–70InterventionalTreatmentAndrew KrystalInvestigator-initiated
~10 participants
Updated 2025-08-17 on ClinicalTrials.gov
What's tested:Device: Stimulation-ONDevice: Stimulation-OFFDevice: Stimulation -ON Active Control
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Montgomery-Asberg Depression Rating Scale (MADRS) score
Measured over Administered twice at baseline and every 2 weeks for the 36-40 weeks of Stage 3
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Andrew Krystal, MD, MS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age 22-70
Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Bipolar II Disorder, with an episode of depression lasting at least 1 year that is treatment resistant as defined above, without a manic or hypomanic episode in the last 2 years; patients must be taking a mood stabilizer (lithium \>0.6 mEq/L or valproate \>350 mM/L), an atypical antipsychotic, or a combination of a mood stabilizer and an atypical antipsychotic for at least 2 weeks at a stable dosage before starting the study and must continue taking anti-manic medication throughout their participation in the study unless discontinuation is necessary because of patient safety/health considerations.
Must have either failed ECT (it was effective but not tolerated due to side effects; it was effective, but patients could not achieve a sustained response), not been able to complete a course of ECT due to side effects, or have been medically advised to receive ECT and have been unwilling or unable to obtain ECT.
Has MADRS score of \> 26 at two baseline visits
Ability to complete repeated administrations of MDD rating scales.
If patient is on a regimen of psychotropic medication, no changes in this regimen should be expected during the 4 weeks prior to entry into and the duration of the study.
Willing and able to undergo invasive brain recording/stimulation study
Willing and able to attend multiple research visits and perform at-home research protocol
Willing and able to provide informed consent
Ability to speak and read English
Exclusion
Meets DSM-V criteria for a psychotic disorder, eating disorder, panic disorder, posttraumatic stress disorder, obsessive compulsive disorder, tic disorder, or another comorbid psychiatric disorder other than MDD or generalized anxiety disorder based on a SCID
Generalized anxiety disorder is the primary DSM-V disorder during the current MDD episode
Active suicidal ideation with intent and plan as defined by a score of 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
History of suicide attempt requiring hospitalization in previous 2 years.
Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, determined by the SCID
Has a personality disorder based on the investigator's assessment that the investigator believes will adversely impact subject compliance or safety
Fibromyalgia or chronic fatigue syndrome
Current condition requiring chronic narcotic use
History of traumatic brain injury, another neurological disorder, or developmental delay
History of seizures
MRI (done within one year of the first visit) with significant abnormalities
Previous ablative intracranial surgery or previously implanted deep brain stimulation system or any previously implanted device treatment involving brain stimulation
Implantable hardware not compatible with MRI or with the study
Major medical co-morbidities increasing the risk of surgery including severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation other than aspirin, active infection, intracranial space occupying lesion, increased intracranial pressure, cardiovascular accident within the last month, aneurysm/abnormality, retinal detachment, unstable cardiovascular disease (recent myocardial infarction, severe ischemia, severe or uncontrolled hypertension), immunocompromised state, or malignancy with \< 5 years life expectancy
Inability to stop Coumadin or platelet anti-aggregation therapy for surgery and after surgery. - Patients taking these medications will need to discuss the need/risk of continuing these medications with their physicians and the PI or study personnel may contact the treating physician(s) to discuss the risks of anticoagulation/antiaggregation therapy discontinuation
Coagulopathy. Patients will be excluded unless assessed and cleared by hematology
Allergies or known hypersensitivity to materials in the NeuroPace RNS® System (i.e. titanium, polyurethane, silicone, polyetherimide, stainless steel)
Subject lives alone without possibility of caregiver support post-hospital stay
Inability to comply with study follow-up visits
What this trial measures
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) scoreAdministered twice at baseline and every 2 weeks for the 36-40 weeks of Stage 3
Effect size comparing closed-loop stimulation, open-loop (fixed intermittent) stimulation, and sham stimulation (MADRS score before and after each treatment period of the crossover). Higher MADRS score indicates more severe depression; the overall score ranges from 0 to 60.