Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder: Efficacy and Mechanism of Ventral Internal Capsue and Nucleus Accumbens

Ruijin Hospital1 site in 1 country20 target enrollmentJanuary 10, 2020

ConditionsObsessive-Compulsive Disorder Deep Brain Stimulation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obsessive-Compulsive Disorder
Sponsor: Ruijin Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

January 10, 2020

End Date

December 31, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

Bomin Sun

Director of Functional Neurosurgery Department

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score

Time Frame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

Y-BOCS is used to rate the severity of OCD symptoms by clinicians. Higher score means more severe OCD symptoms.

Secondary Outcomes

Adverse Events(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Change in Yale-Brown Obsessive-Compulsive Scale-Self Report (Y-BOCS-SR) Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Changes in Hamilton Anxiety Scale Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Changes in Hamilton Depression Scale-17 Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Magnetic resonance imaging (MRI) images(Baseline (preoperative))
Change in memory(Baseline (preoperative),6 months or 12 months)
Change in impulsivity and compulsivity(Baseline (preoperative),6 months or 12 months)
Change in Young Manic Rating Scale(YMRS)(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Changes in WHOQOL-BREF score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Changes in PSS-10 score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Change in Sheehan Disability Scale(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Changes in SF-36 score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Changes in Q-LES-Q-SF score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Changes in PSQI score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
Changes in PANAS score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)