Actively Recruiting
Building Mood State Classifiers to Inform Deep Brain Stimulation of Treatment-Resistant Bipolar Depression
Led by Wayne Goodman MD · Updated on 2026-01-26
10
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Wayne Goodman MD
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of Deep Brain Stimulation (DBS) in people with severe treatment-resistant bipolar depression (TRBD). This study is conducted only at Baylor College of Medicine and aims to improve DBS targeting to better manage symptoms of TRBD by surgically implanting electrodes in specific brain areas. DBS delivers electrical currents to influence brain circuits involved in bipolar depression, but participants should understand that this is experimental and may not provide direct benefit. Risks include brain bleeding, infection, seizures, and other potential complications. Participants will undergo a detailed screening process including medical, psychiatric, and cognitive evaluations before surgery. The study involves implanting a Medtronic Percept RC DBS system with bilateral leads targeting specific brain regions. After surgery, the device will be activated and programmed over several visits. The study includes a blinded discontinuation period at 12 months to assess ongoing DBS effects. Participants will stay locally during several 24-hour monitoring periods in the NeuroBehavioral Unit to collect neural and behavioral data, using wearable sensors and mobile apps. Throughout the 20-month study, participants will attend about 23 visits for clinical assessments, questionnaires, neuropsychological and behavioral testing, and device programming. Data collection includes brain imaging, mood and mania rating scales, side effect monitoring, and continuous behavioral and neural recordings. Safety and symptom changes will be closely tracked using standardized tools like the Montgomery-Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). The study aims to better understand DBS effects and improve treatment for TRBD.
CONDITIONS
Brief Title
Deep Brain Stimulation of Treatment-Resistant Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 22 to 64, inclusive
- Diagnosis of Bipolar I disorder currently in a major depressive episode confirmed by SCID-5
- Montgomery-Asberg Depression Rating Scale (MADRS) score of 27 or higher at screening and baseline
- Clinical Global Impressions Scale (CGI-S) greater than 4 and Young Mania Rating Scale (YMRS) less than 12 at screening and baseline
- History of failure to respond or maintain response to at least four evidence-based bipolar depression treatments, including two FDA-approved medications or electroconvulsive therapy
- Currently taking at least one evidence-based medication for bipolar disorder or unable to tolerate such medications
- Initial mood episode occurred before age 40
- Stable dose of psychotropic medications for at least four weeks prior to surgery
- Minimum score on the Montreal Cognitive Assessment (MoCA)
- Able and willing to give informed consent and sign a treatment contract including identification of a reliable informant
You will not qualify if you...
- Lifetime history of psychotic disorder or psychotic symptoms outside bipolar mood episodes
- Currently in a manic or hypomanic episode or experiencing rapid cycling (4 or more mood episodes in past 12 months)
- Primary psychiatric disorder other than bipolar disorder treated in past 12 months
- Moderate or severe alcohol or substance use disorder in past 12 months (excluding nicotine)
- Intellectual disability or neurocognitive disorder
- Major unstable medical conditions such as liver, kidney, cardiovascular issues, infections, cancer, or major neurological disorders
- Medical contraindication to surgery or poor surgical candidate
- Pregnant, breastfeeding, or planning pregnancy within 24 months
- Contraindications for MRI
- Clinically significant personality disorder impacting safety or psychiatric status
- Serious risk of suicide making outpatient participation unsuitable
- Participation in another investigational clinical trial within past 30 days
- Current implanted stimulation devices like pacemakers or neurostimulators
- No regular contact with at least one adult or undomiciled
- Body mass index (BMI) less than 16 or greater than 40 kg/m2
- Need for diathermy treatment
- Unable to sign informed consent
- Not under psychiatric care at screening and throughout study duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 visits (screening and baseline visits spaced over approximately 1 month)
Duration - 1 day
Participants undergo implantation of bilateral deep brain stimulation leads targeting specific brain regions using a robotic surgical workflow with intraoperative behavioral testing to determine optimal lead placement.
1 surgical visit (in-person)
Duration - Approximately 12 months
Participants receive device activation and ongoing deep brain stimulation programming with frequent visits for assessment and optimization, including multiple stays in a NeuroBehavioral Unit for high-density neural and behavioral monitoring.
Weekly visits for the first 8 weeks, then monthly visits through month 12; 8 total 24-hour NeuroBehavioral Unit stays
Duration - 1 month
Participants undergo a one month blinded discontinuation where the deep brain stimulation device is turned off gradually to assess dependence on ongoing stimulation.
Visits during gradual taper period with clinical evaluations
Duration - Up to 8 months
Participants are monitored with monthly clinical evaluations to assess efficacy and safety after the discontinuation period, with decisions made about restarting or deactivating the device.
Monthly visits through month 20, including final study visit at month 20
Trial Site Locations
Total: 4 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
2
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
3
Rice University
Houston, Texas, United States, 77030
Active, Not Recruiting
4
University of Washington
Seattle, Washington, United States, 98195
Active, Not Recruiting
Research Team
M
Michelle Avendano
L
Luke Jumper
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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