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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Zhen Wang, Ph.D, M.D
• Email: wangzhen@smhc.org.cn
• Phone: +8602164387250

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.