NCT07127913 Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
| NCT ID | NCT07127913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Andrew Krystal |
| Condition | Bipolar II Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2030-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-07-16 with a primary completion date of 2030-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Andrew Krystal, MD, MS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07127913 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 70 Years, studying Bipolar II Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07127913 currently recruiting?
Yes, NCT07127913 is actively recruiting participants. Contact the research team at trdepression@ucsf.edu for enrollment information.
Where is the NCT07127913 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07127913 clinical trial?
NCT07127913 is sponsored by Andrew Krystal. The principal investigator is Andrew Krystal, MD, MS at University of California, San Francisco. The trial plans to enroll 10 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.