RecruitingNot ApplicableNCT07031544

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

Efficacy and Influencing Factors of Combined Anterior Limb of Internal Capsule and Nucleus Accumbens Deep Brain Stimulation in Treatment-Refractory Obsessive-Compulsive Disorder


Sponsor

Shanghai Mental Health Center

Enrollment

60 participants

Start Date

Dec 14, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a brain stimulation procedure called deep brain stimulation (DBS) targeting a specific brain region to treat severe, treatment-resistant OCD (obsessive-compulsive disorder) — a condition where unwanted thoughts and repetitive behaviors are very difficult to control even with standard treatments. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with OCD based on standard psychiatric criteria (DSM-5) - Your OCD symptoms are severe (high score on the Y-BOCS scale) - You have tried and failed multiple standard OCD treatments, including medication and therapy **You may NOT be eligible if...** - Your OCD has responded to standard treatments - You have certain other psychiatric or medical conditions that make brain surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEdeep 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.


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 Huanhu Hospital

Tianjin, China

Tianjin Anding Hospital

Tianjing, China

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NCT07031544


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