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
aged 18-65 years old;
a diagnosis of OCD based on The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5);
the Y-BOCS total score ≥ 25;
met the criteria of treatment refractory. Treatment refractory is defined as failed a) Inadequate response or intolerance to at least three adequate trials of selective serotonin reuptake inhibitors (SSRIs), combined with at least two second-generation antipsychotics as augmentation agents.
Presence of other psychiatric disorders such as organic mental disorders, paranoid personality disorder, or mental retardation.
Individuals deemed by the investigator to be at significant risk of suicidal behavior based on clinical assessment.
Presence of severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, neurological, or other systemic diseases.
History of organic brain disorders, traumatic brain injury, intractable epilepsy, or other neurological conditions.
Shanghai Mental Health Center
Lead sponsor
Huashan Hospital
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Tianjin Anding Hospital
Collaborator
Tianjin Huanhu Hospital
Collaborator
The First Hospital of Hebei Medical University
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
The Second Affiliated Hospital of Xinxiang Medical College
Collaborator
the Third Hospital of Mianyang
Collaborator