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
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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