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Efficacy and Influencing Factors of ALIC-NAc Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder
Led by Shanghai Mental Health Center · Updated on 2025-07-03
60
Participants Needed
10
Research Sites
119 weeks
Total Duration
On this page
Sponsors
S
Shanghai Mental Health Center
Lead Sponsor
H
Huashan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Influencing Factors of ALIC-NAc Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-65 years old
- Diagnosed with obsessive-compulsive disorder (OCD) according to DSM-5
- Y-BOCS total score of 25 or higher
- Treatment refractory defined as: a) Inadequate response or intolerance to at least three adequate trials of SSRIs combined with at least two second-generation antipsychotics b) Inadequate response or intolerance to cognitive behavioral therapy (CBT) of more than 12 sessions conducted alongside 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
- Considered at significant risk of suicidal behavior by investigator
- 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
- Clinically significant abnormalities in physical exam, lab tests, ECG, or imaging making participation unsuitable
- History of cochlear implant, cardiac pacemaker, defibrillator, similar device implantation, or other surgery within past 6 months affecting participation
- Contraindications to DBS implantation or unfit for surgery
- Confirmed HIV-positive status
- Pregnant or breastfeeding women, women of childbearing potential with positive pregnancy tests, those unable to use effective contraception, or planning to conceive within 3 months after study start
- Participation in another drug or medical device clinical trial currently or within 3 months prior to screening
- Any other condition making the individual unsuitable for the study as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 10 locations
1
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Actively Recruiting
2
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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3
The Second Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
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4
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
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5
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
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6
the Third Hospital of Mianyang
Mianyang, Sichuan, China
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7
Shanghai Mental Health Center
Shanghai, China, 200030
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8
Huashan Hospital
Shanghai, China
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9
Tianjin Huanhu Hospital
Tianjin, China
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10
Tianjin Anding Hospital
Tianjing, China
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Research Team
Z
Zhen Wang, Ph.D, M.D
CONTACT
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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