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Efficacy and Influencing Factors of ALIC-NAc Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria revised
    • Secondary endpoints: details revised at 3 of 4 entries
    • Publications: details revised at 10 of 10 entries
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate the efficacy and influencing factors of the combination of the anterior limb of internal capsule and nucleus accumbens (ALIC-NAc) deep brain stimulation (DBS) in patients with treatment-refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer is: Does the timing of DBS activation (at 1, 2, or 3 months post-surgery) affect the reduction rate in Y-BOCS scores? Researchers will compare three groups-DBS activated at 1, 2, and 3 months post-surgery-to determine whether earlier or later stimulation leads to greater symptom improvement. Participants will: * Undergo surgical implantation of an intracranial neurostimulation system targeting ALIC-NAc * Be randomly assigned to one of three DBS activation timing groups * Receive regular clinical assessments over a 6-month follow-up period after activation
Trial Details
NCT Number NCT07031544
Lead Sponsor Shanghai Mental Health Center
Collaborators: Huashan Hospital, The First Affiliated Hospital of Shanxi Medical University, The First Affiliated Hospital of Nanchang University, Tianjin Anding Hospital, Tianjin Huanhu Hospital, The First Hospital of Hebei Medical University, First Affiliated Hospital of Jinan University, The Second Affiliated Hospital of Xinxiang Medical College, the Third Hospital of Mianyang
Conditions
(from sponsor)		 Obsessive - Compulsive Disorder
Related terms Compulsive Personality Disorder, Obsessive-Compulsive Disorder
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov