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

Not Applicable

• Conditions: Deep Brain Stimulation; Obsessive-Compulsive Disorder
• Interventions: Device: DBS system

• Registration Number: NCT04228744
• Lead Sponsor: Ruijin Hospital

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-05
• Study Start: 2020-01-10
• Study First Submitted QC: 2020-01-11
• Last Update Submitted: 2020-01-11
• Study First Posted: 2020-01-14
• Last Update Posted: 2020-01-14
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bilateral surgical implantation of DBS system	DBS system	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.

Primary Outcome Measures

Name	Time	Method
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score	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 Outcome Measures

Name	Time	Method
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	The Y-BOCS-SR is a self-report version of the clinician-rated Y-BOCS. It consists of 10 items rated on a 5-point Likert scale (0 to 4) with higher scores denoting greater symptom severity.
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	The Y-BOCS-II was created given several overarching concerns about the original Y-BOCS. Each item is rated from 0 to 5, and higher score means more severe OCD symptoms.
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The OCI-R is an 18-item self-reported scale that assesses the degree of distress caused by OCD symptoms. Each item is rated from "not at all" (codes as 0) to "extremely" (codes as 4), and three items constitute a subtype of OCD symptoms.
Changes in Hamilton Anxiety Scale Score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The Hamilton Anxiety Scale is a clinician-rated scale. Higher scores indicate more severe anxiety.
Changes in Hamilton Depression Scale-17 Score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The Hamilton Depression Scale-17 is a clinician-rated scale. Higher scores indicate more severe depression.
Magnetic resonance imaging (MRI) images	Baseline (preoperative)	The MRI images contains resting, multi-tasks related, and structural states.
Change in memory	Baseline (preoperative),6 months or 12 months	The CANTAB software research is used to assess memory and learning. The tasks incude spatial working memory task, paired associated learning task, pattern recognition memory task.
Change in impulsivity and compulsivity	Baseline (preoperative),6 months or 12 months	The computerized tasks are used to measure impulsivity and compulsivity. The tasks include stop single task, beads task, model-based modle-free task and habit task.
Change in Young Manic Rating Scale(YMRS)	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The YMRS is a 11-item rating scale used to evaluate manic symptoms. Higher score indicates more severe mania.
Changes in WHOQOL-BREF score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The WHOQOL-BREF is used to measure the quality of life. The higher score means higher quality of life.
Changes in PSS-10 score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The perceived stress scale (PSS-10) is used to measure stress levels and contains 10 items rated from "never" (coded as 0) to "very often" (coded as 4). Higher score means higher level of stress.
Change in Sheehan Disability Scale	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The Sheehan Disability Scale is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired. The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale.
Changes in SF-36 score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The 36-Item Short Form Survey (SF-36) is used to measure the quality of life. The higher score means higher quality of life.
Changes in Q-LES-Q-SF score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The quality of life enjoyment and satisfaction questionnaire - short form (Q-LES-Q-SF) is used to measure the quality of life. The higher score means higher quality of life.
Changes in PSQI score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The pittsburgh sleep quality index (PSQI) is used to measure the quality and patterns of sleep. Higher score means poorer quality of sleep.
Changes in PANAS score	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months	The positive and negative affective schedule (PANAS) consists of 20 words that describe different feeling and emotions. 10 words constitute negative affect and positive affect subscales. Each word was rated from "very slightly or not at all" (coded as 1) to "extremely" (coded as 5). Higher score means higher level of positive or negative affect.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China