RecruitingNot Applicable

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

United States10 participantsStarted 2025-07-16

Plain-language 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.

Who can participate

Age range22 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Change in Montgomery-Asberg Depression Rating Scale (MADRS) score

Timeframe: Administered twice at baseline and every 2 weeks for the 36-40 weeks of Stage 3

Trial details

NCT IDNCT07127913

SponsorAndrew Krystal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-06-28

Contact for this trial

Andrew Krystal, MD, MS

510-621-3193 trdepression@ucsf.edu