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

NCT04967560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-18

No results posted yet for this 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.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

DEVICE

deep brain stimulation

Both group will undergo the DBS surgery. Four weeks after surgery, all patients will visit the clinic with the DBS stimulation in the 'off' state for initial programming of electrical parameters for stimulation. At double-blind visit, the electrical stimulation will be actually 'turned on' immediately after the programming in true-stimulation group, while turn-off in the control group.

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER
  • Huashan Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • Hunan Brain Hospital

    collaborator UNKNOWN
  • First Affiliated Hospital of Kunming Medical University

    collaborator OTHER
  • Changhai Hospital

    collaborator OTHER
  • SceneRay Corporation, Limited

    collaborator INDUSTRY
  • Shanghai Mental Health Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2023-11-13
Completion
2024-01-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04967560 on ClinicalTrials.gov