Efficacy and Influencing Factors of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

• b) Inadequate response or intolerance to cognitive behavioral therapy (CBT) consisting of more than 12 sessions conducted concurrently with adequate dosed SSRIs treatment.

Locations
Other Locations
China
First Affiliated Hospital of Jinan University
RECRUITING
Guangzhou
the Third Hospital of Mianyang
RECRUITING
Mianyang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Huashan Hospital
RECRUITING
Shanghai
Shanghai Mental Health Center
RECRUITING
Shanghai
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Tianjin Huanhu Hospital
RECRUITING
Tianjin
Tianjin Anding Hospital
RECRUITING
Tianjing
The Second Affiliated Hospital of Xinxiang Medical College
RECRUITING
Xinxiang
Contact Information
Primary
Zhen Wang, Ph.D, M.D
wangzhen@smhc.org.cn
+8602164387250
Time Frame
Start Date: 2024-12-14
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 60
Treatments
Experimental: one-month group
DBS activation at 30 ± 7 days post-surgery
Experimental: two-month group
DBS activation at 60 ± 7 days post-surgery
Experimental: three-month group
DBS activation at 90 ± 7 days post-surgery
Sponsors
Collaborators: Tianjin Huanhu Hospital, The First Affiliated Hospital of Nanchang University, Tianjin Anding Hospital, The First Hospital of Hebei Medical University, The First Affiliated Hospital of Shanxi Medical University, Huashan Hospital, the Third Hospital of Mianyang, The Second Affiliated Hospital of Xinxiang Medical College, First Affiliated Hospital of Jinan University
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov