Efficacy and Influencing Factors of ALIC-NAc Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder

Not Applicable

Recruiting

• Conditions: Obsessive - Compulsive Disorder

• Registration Number: NCT07031544
• Lead Sponsor: Shanghai Mental Health Center

Brief 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

Detailed Description

This trial adopted a prospective, multicenter, randomized, open-label, parallel-group design. The study population comprised patients with treatment-refractory obsessive-compulsive disorder whose symptoms could not be effectively controlled by pharmacotherapy and psychotherapy. After providing informed consent, participants underwent implantation of an intracranial neurostimulation system, followed by scheduled activation of stimulation post-surgery.

A total of 60 patients were planned for enrollment and randomly assigned to one of three groups based on the timing of stimulation initiation: the one-month group (activation at 30 ± 7 days post-surgery), the two-month group (activation at 60 ± 7 days), and the three-month group (activation at 90 ± 7 days), with 20 participants in each group (1:1:1 allocation). Participants followed the trial schedule for regular assessments. The primary outcome was the difference in Y-BOCS reduction rates among the three groups at 90 ± 7 days after stimulation initiation.

Study Timeline

• Study Start: 2024-12-14
• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Obsessive-compulsive symptoms improvement	3-month after DBS activation	The severity of OCD symptoms is assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive symptoms improvement is reflected by Y-BOCS reduction rate.

Secondary Outcome Measures

Name	Time	Method
the change scores of CGI score	1, 2 and 3-month after DBS activation	The Clinical Global Impressions (CGI) is an invaluable tool for monitoring the treatment outcomes of patients. The CGI actually comprises three companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7, (b) change from the initiation of treatment on a similar seven-point scale, and (c) an overall evaluation of the therapeutic effect and side effects.
the change scores of HAMA score	1, 2 and 3-month after DBS activation	The Hamilton Anxiety Rating Scale (HAM-A) was one of the first rating scales developed to measure the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety and somatic anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
the change scores of HAMD score	1, 2 and 3-month after DBS activation	The Hamilton Depression Rating Scale (HAM-D) is used to quantify the severity of symptoms of depression and is one of the most widely used and accepted instruments for assessing depression. It contains 24 items rated on 5-point scale, with the sum of all items making up the total score, yielding total scores from zero to 96. The higher score means more severity of depression symptoms.
the change of SF-36 score	1, 2 and 3-month after DBS activation	The Short Form-36 Health Survey (SF-36) comprises eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health. It also includes one item assessing perceived health change. These domains can be summarized into two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

Trial Locations

Locations (10)

First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Xinxiang Medical College; 🇨🇳 Xinxiang, Henan, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The First Affiliated Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

the Third Hospital of Mianyang; 🇨🇳 Mianyang, Sichuan, China

Shanghai Mental Health Center; 🇨🇳 Shanghai, China

Huashan Hospital; 🇨🇳 Shanghai, China

Tianjin Anding Hospital; 🇨🇳 Tianjing, China

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, China