Clinical trial NCT04228744: The Efficacy and Mechanism of DBS in VIC and NAcc for Refractory OCD
Official title: Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder: Efficacy and Mechanism of Ventral Internal Capsue and Nucleus Accumbens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Deep Brain Stimulation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2020-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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;

Primary outcomes:
measure: Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Secondary outcomes:
measure: Change in Yale-Brown Obsessive-Compulsive Scale-Self Report (Y-BOCS-SR) Score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Adverse Events
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Changes in Hamilton Anxiety Scale Score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Changes in Hamilton Depression Scale-17 Score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Magnetic resonance imaging (MRI) images
timeFrame: Baseline (preoperative)
measure: Change in memory
timeFrame: Baseline (preoperative),6 months or 12 months
measure: Change in impulsivity and compulsivity
timeFrame: Baseline (preoperative),6 months or 12 months
measure: Change in Young Manic Rating Scale(YMRS)
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Changes in SF-36 score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Changes in WHOQOL-BREF score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Changes in Q-LES-Q-SF score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Changes in PSQI score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Changes in PSS-10 score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Changes in PANAS score
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
measure: Change in Sheehan Disability Scale
timeFrame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Bomin Sun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cambridge
name: Valerie Voon, PhD
role: PRINCIPAL_INVESTIGATOR
References: