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

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

Conditions

• Obsessive - Compulsive Disorder

Interventions

DEVICE

deep brain stimulation

Deep Brain Stimulation (DBS) involves the use of stereotactic techniques to implant microelectrodes into specific target nuclei within the brain through minimally invasive surgery. These electrodes are connected via leads to a subcutaneously implanted pulse generator, typically placed beneath the clavicle. By delivering low-intensity electrical pulses, DBS suppresses abnormal intracranial neural activity, thereby alleviating symptoms. Long-term stimulation can also induce neuroplastic changes in neural networks and neurotransmitter systems, contributing to the restoration of neurological function.

Sponsors & Collaborators

• Huashan Hospital

  collaborator OTHER

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Tianjin Anding Hospital

  collaborator OTHER

• Tianjin Huanhu Hospital

  collaborator OTHER

• The First Hospital of Hebei Medical University

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• The Second Affiliated Hospital of Xinxiang Medical College

  collaborator UNKNOWN

• the Third Hospital of Mianyang

  collaborator UNKNOWN

• Shanghai Mental Health Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-14

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• China

Study Locations