The Efficacy and Mechanism of DBS in VIC and NAcc for Refractory OCD

Shanghai Jiao Tong University

Status: Unknown

Conditions: Obsessive-Compulsive Disorder; Deep Brain Stimulation

Treatments: Device: DBS system

Study type: Interventional

Funder types: Other

Identifiers

NCT04228744

2019 NAc VIC DBS OCD

Details and patient eligibility

About

This study will evaluate the efficacy and explore the mechanism of deep brain stimulation (DBS) in the ventral internal capsule (VIC) and nucleus accumbens (NAc) for refractory obsessive-compulsive disorder (OCD).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of OCD with duration of at least 5 years;
2. Severity rated as severe to extreme illness;
3. Failed adequate trial of at least three specific serotonin reuptake inhibitor (SSRI) antidepressants;
4. Failed augmentation with antipsychotic;
5. Completed or failed to complete adequate trial of cognitive behavioural therapy for OCD;
6. Stable medication regimen for one month before surgery;
7. Signed informed consent;

Exclusion criteria

1. Hoarding as a primary symptom;
2. No other serious psychiatric disorder such as psychotic disorder;
3. Drug or substance use disorder within 6 months except nicotine;
4. Major Neurological/Medical condition;
5. High suicide risk;
6. Pregnancy or lactation;
7. Contraindications to stereotactic surgery;
8. Contraindications to MRI;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Bilateral surgical implantation of DBS system

Experimental group

Description:

All the participants will receive bilateral surgical implantation of DBS system to VIC and NAc. The experimenter will active the DBS system and adjust the parameters for all the participants after surgery.

Treatment:

Device: DBS system