Deep brain stimulation of the anterior limb of the internal capsule and nucleus accumbens for treatment‑resistant OCD

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

This trial will test whether turning on deep brain stimulation at 1, 2, or 3 months after surgery changes symptom improvement in adults with treatment‑resistant OCD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 10 sites (Guangzhou, Guangdong and 9 other locations)
• Trial ID: NCT07031544 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, randomized, open‑label, parallel‑group trial enrolled 60 adults with DSM‑5 obsessive‑compulsive disorder who remained symptomatic despite adequate medication and CBT. All participants underwent implantation of an intracranial neurostimulation system targeting the anterior limb of the internal capsule and nucleus accumbens and were randomized 1:1:1 to activation at 30±7, 60±7, or 90±7 days after surgery. Clinical assessments including the Y‑BOCS were performed regularly, with the primary outcome the difference in Y‑BOCS reduction rates among the three groups at 90±7 days after stimulation initiation. Follow‑up continued for six months after activation to track symptom trajectories and adverse events.

Who should consider this trial

Good fit: Adults aged 18–65 with DSM‑5 obsessive‑compulsive disorder, a Y‑BOCS score ≥25, and documented treatment refractoriness to multiple adequate SSRI trials, antipsychotic augmentation, and adequate CBT are the intended candidates.

Not a fit: Patients with comorbid organic mental disorders, certain personality disorders, significant suicide risk, severe unstable medical conditions, or those whose OCD responds to standard treatment are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If timing matters, choosing the optimal activation window could lead to faster or larger symptom improvements for people receiving DBS for treatment‑resistant OCD.

How similar studies have performed: Previous nonrandomized and some controlled studies have shown symptomatic benefit from ALIC/NAcc‑targeted DBS in treatment‑resistant OCD, but randomized comparisons focusing specifically on activation timing are limited.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Clinically significant abnormalities in physical examination, laboratory tests, electrocardiogram, or imaging during screening or baseline that, in the investigator's judgment, make the individual unsuitable for the study.
* History of implantation of a cochlear implant, cardiac pacemaker, cardiac defibrillator, prior unilateral or bilateral implantation of similar devices, or other surgical procedures within the past six months that may affect study participation as judged by the investigator.
* Contraindications to DBS implantation or deemed unfit for surgery by the investigator.
* Confirmed HIV-positive status.
* Pregnant or breastfeeding women, women of childbearing potential with positive blood/urine HCG results at screening, those unable to use effective contraception during the study, or those planning to conceive within three months after study initiation.
* Participation in another drug or medical device clinical trial currently or within three months prior to screening.
* Any other condition deemed by the investigator to render the individual unsuitable for the study.

Where this trial is running

Guangzhou, Guangdong and 9 other locations

• First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (Recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• The Second Affiliated Hospital of Xinxiang Medical College — Xinxiang, Henan, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Affiliated Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• the Third Hospital of Mianyang — Mianyang, Sichuan, China (Recruiting)
• Shanghai Mental Health Center — Shanghai, China (Recruiting)
• Huashan Hospital — Shanghai, China (Recruiting)
• Tianjin Huanhu Hospital — Tianjin, China (Recruiting)
• Tianjin Anding Hospital — Tianjing, China (Recruiting)

Study contacts

• Study coordinator: Zhen Wang, Ph.D, M.D

Conditions Obsessive - Compulsive Disorder; obsessive-compulsive disorder; deep brain stimulation; anterior limb of internal capsule; nucleus accumbens; activation timing