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

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Conditions

Bipolar II DisorderBipolar II Disorder, Most Recent Episode Major DepressiveDepressionTreatment-resistanceDeep brain stimulationClosed-loopBiomarkerResponsive neurostimulationBrain surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Closed-Loop Deep Brain Stimulation for Bipolar Depression (PReSiDio-BP)

Quick Facts

Study Start:2025-07-16
Study Completion:2035-06-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07127913

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 22-70
  2. * 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.
  3. * 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.
  4. * Has MADRS score of \> 26 at two baseline visits
  5. * Ability to complete repeated administrations of MDD rating scales.
  6. * 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.
  7. * Willing and able to undergo invasive brain recording/stimulation study
  8. * Willing and able to attend multiple research visits and perform at-home research protocol
  9. * Willing and able to provide informed consent
  10. * Ability to speak and read English
  1. * 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
  2. * Generalized anxiety disorder is the primary DSM-V disorder during the current MDD episode
  3. * Active suicidal ideation with intent and plan as defined by a score of 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
  4. * History of suicide attempt requiring hospitalization in previous 2 years.
  5. * Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, determined by the SCID
  6. * Has a personality disorder based on the investigator's assessment that the investigator believes will adversely impact subject compliance or safety
  7. * Fibromyalgia or chronic fatigue syndrome
  8. * Current condition requiring chronic narcotic use
  9. * History of traumatic brain injury, another neurological disorder, or developmental delay
  10. * History of seizures
  11. * MRI (done within one year of the first visit) with significant abnormalities
  12. * Previous ablative intracranial surgery or previously implanted deep brain stimulation system or any previously implanted device treatment involving brain stimulation
  13. * Implantable hardware not compatible with MRI or with the study
  14. * 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
  15. * 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
  16. * Coagulopathy. Patients will be excluded unless assessed and cleared by hematology
  17. * Allergies or known hypersensitivity to materials in the NeuroPace RNS® System (i.e. titanium, polyurethane, silicone, polyetherimide, stainless steel)
  18. * Subject lives alone without possibility of caregiver support post-hospital stay
  19. * Inability to comply with study follow-up visits

Contacts and Locations

Study Contact

Andrew Krystal, MD, MS
CONTACT
510-621-3193
trdepression@ucsf.edu
Natalie Becker, BS
CONTACT
510-621-3193
trdepression@ucsf.edu

Principal Investigator

Andrew Krystal, MD, MS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Andrew Krystal

  • Andrew Krystal, MD, MS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16
Study Completion Date2035-06-28

Study Record Updates

Study Start Date2025-07-16
Study Completion Date2035-06-28

Terms related to this study

Keywords Provided by Researchers

  • Bipolar II Disorder
  • Depression
  • Treatment-resistance
  • Deep brain stimulation
  • Closed-loop
  • Biomarker
  • Responsive neurostimulation
  • Brain surgery

Additional Relevant MeSH Terms

  • Bipolar II Disorder
  • Bipolar II Disorder, Most Recent Episode Major Depressive