Study of Timing Effects of Deep Brain Stimulation in Adults with Treatment-Resistant Obsessive-Compulsive Disorder
Targeting Anterior Limb of Internal Capsule and Nucleus Accumbens
Led by Shanghai Mental Health Center · Updated on 2025-07-03
60
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating deep brain stimulation DBS targeting the anterior limb of internal capsule and nucleus accumbens ALIC-NAc in patients with treatment-refractory obsessive-compulsive disorder OCD. The study aims to find out whether the timing of DBS activationat 1, 2, or 3 months after surgeryaffects the improvement of OCD symptoms measured by Y-BOCS scores. This multicenter, randomized, open-label trial involves adults who have not responded to standard medications and therapy.
Participants will undergo surgery to implant a neurostimulation device in the brain. They will be randomly assigned to one of three groups receiving DBS activation at approximately 30, 60, or 90 days after surgery. Each group includes 20 patients. After activation, participants will be regularly assessed over a six-month follow-up period to compare symptom improvements based on activation timing.
During the study, participants will attend scheduled clinical visits for evaluations including OCD symptom scores, depression and anxiety ratings, and quality of life assessments. The main measurement is the difference in OCD symptom improvement three months after DBS activation. Secondary measures include changes in clinical global impression, depression, anxiety, and health survey scores at one, two, and three months post-activation. Safety and suitability assessments will also be conducted throughout the trial, which is expected to complete by March 2027.
CONDITIONS
Brief Title
Efficacy and Influencing Factors of ALIC-NAc Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder
Research Team
Z
Zhen Wang, Ph.D, M.D
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Diagnosed with obsessive-compulsive disorder based on DSM-5
Y-BOCS total score of 25 or higher
Treatment refractory, defined as inadequate response or intolerance to at least three adequate SSRI trials combined with at least two second-generation antipsychotics
Inadequate response or intolerance to cognitive behavioral therapy with more than 12 sessions concurrent with adequate SSRI treatment
You will not qualify if you...
Presence of other psychiatric disorders such as organic mental disorders, paranoid personality disorder, or mental retardation
Significant risk of suicidal behavior as assessed by investigator
Severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, neurological, or systemic diseases
History of organic brain disorders, traumatic brain injury, intractable epilepsy, or other neurological conditions
Clinically significant abnormalities in physical exams, labs, ECG, or imaging making participation unsuitable
History of cochlear implant, cardiac pacemaker, defibrillator, or similar device implantation within past six months
Contraindications to DBS implantation or unfit for surgery
Confirmed HIV-positive status
Pregnant or breastfeeding women, or women of childbearing potential with positive pregnancy tests or unable to use effective contraception
Participation in another drug or device clinical trial currently or within three months prior
Any other condition deemed unsuitable by the investigator
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo implantation of an intracranial neurostimulation system through minimally invasive surgery and receive immediate post-operative care.
1 visit (in-person)
Post-operative Follow-up
Duration - 30 to 90 days depending on group assignment
Participants are monitored without stimulation during the post-surgery period until activation of the deep brain stimulation device.
Regular follow-up visits during this period
Treatment
Duration - At least 3 months after DBS activation
Participants receive deep brain stimulation therapy, with activation occurring at 30, 60, or 90 days post-surgery depending on group assignment. The stimulation continues while participants attend scheduled assessments.
Assessments at 1, 2, and 3 months after DBS activation
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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