The Efficacy and Safety of ALIC/NAcc-DBS for Treatment-refractory OCD

Last updated: May 14, 2025
Sponsor: Shanghai Mental Health Center
Overall Status: Completed

Phase

N/A

Condition

Anxiety Disorders

Obsessive-compulsive Disorder

Panic Disorders

Treatment

deep brain stimulation

Clinical Study ID

NCT04967560
SR1182
  • Ages 18-65
  • All Genders

Study Summary

The present study aims to explore the efficacy and safety of DBS targeted the combination of the anterior limb of internal capsule and nucleus accumbens (ALIC/NAcc-DBS) to refractory OCD, based on multicenter, randomized, double-blinded, sham-stimulation controlled design, that could help to obtain stronger evidence of the efficacy of multiple targets.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged 18-65 years old;

  • a diagnosis of OCD based on The Diagnostic and Statistical Manual of MentalDisorders, fifth edition (DSM-5);

  • suffered from severe OCD symptoms over 5 years with substantial functionalimpairment;

  • the Y-BOCS total score ≥ 25;

  • met the criteria of treatment refractory. Treatment refractory is defined as failed

  1. at least three adequate therapeutic trials of serotin reuptake inhibitors (SRIs),with clomipramine being one of the SRIs trials, 2) the use of at least two atypicalantipsychotics as augmenting agents, 3) at least 20 sessions of therapist-guidedcognitive-behavioral therapy while on a therapeutic dose of an SRIs. These patientshave "failed" treatment by demonstrating <25% reduction of Y-BOCS scores or, despite >25% reduction in YBOCS score, by still experiencing significant impairment fromtheir illness.

Exclusion

Exclusion Criteria:

  • a history of current or past diagnosis of any psychosis according to DSM-5 exceptfor OCD

  • any clinical significant neurological disorder, traumatic brain injury, dementia, ormedical illness

  • any contradiction of neurosurgery

  • any current or unstably remitted substance abuse or dependence

  • women who are pregnant or preparing for pregnant

  • severe suicide risk and tendency according to the investigators' judgements

  • participate in any other clinical trials within three months (except for registeredstudies).

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: deep brain stimulation
Phase:
Study Start date:
July 30, 2021
Estimated Completion Date:
January 29, 2024

Study Description

OCD is a chronic and disabled mental disorder, with one third of patients could hardly get recovery from the medication and psychotherapy. Deep brain stimulation (DBS) is a novel potential surgical treatment for refractory OCD, however, the choose of targets are still controversial. This study aims to investigate the therapeutic efficacy and safety of bilateral DBS of the anterior limb of internal capsule and nucleus accumbens (ALIC/NAcc-DBS) for treatment-refractory OCD. In this multicenter, prospective, and double-blinded study, 64 patients with OCD who met the eligibility criteria will be enrolled and randomized allocated to active and sham-stimulation group, followed up for three months after surgery. Then the blind will be uncover, the sham group switch to true stimulation, all patients will be followed up at six months after surgery. The primary outcome was to compare the treatment response rate between the active group and sham-controlled group at the end of three months after surgery. The secondary outcomes include changes in the Yale-brown obsessive-compulsive scale (Y-BOCS), Hamilton anxiety scale (HAMA), Hamilton depression scale (HAMD), and Clinical global impressions (CGI) scale of both groups.

Connect with a study center

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Brains Hospital of Hunan Province

    Changsha, Hunan
    China

    Site Not Available

  • Changhai Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Huashan Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Mental Health Center

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • West China Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Site Not Available

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