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

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

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).

Study Overview

• Status: Unknown
• Conditions: Obsessive-Compulsive Disorder; Deep Brain Stimulation
• Intervention / Treatment: Device: DBS system

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chencheng Zhang, PhD; Phone Number: +086-18217122884; Email: i@cczhang.org

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital
    • Contact: Chencheng Zhang, PhD; Phone Number: 86-18217122884; Email: i@cczhang.org
    • Principal Investigator: Bomin Sun, PhD
    • Principal Investigator: Valerie Voon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Bilateral surgical implantation of 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.

Device: DBS system; The DBS device utilized in the present study includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead contains four stimulating contacts. The length of each contact is 1.5 mm, and the spacing between contacts is 1.5 mm. The participants will receive stepwise surgery. The electrodes will be implanted firstly which will be externalized for several days and then the IPG will be implanted. During externalization, the experimenters will record the local field potential and electroencephalography in resting or task-based state with conditions of sham-stimulation or active-stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score	Y-BOCS is used to rate the severity of OCD symptoms by clinicians. Higher score means more severe OCD symptoms.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Yale-Brown Obsessive-Compulsive Scale-Self Report (Y-BOCS-SR) Score	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.	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	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.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score	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.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Adverse Events		Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Changes in Hamilton Anxiety Scale Score	The Hamilton Anxiety Scale is a clinician-rated scale. Higher scores indicate more severe anxiety.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Changes in Hamilton Depression Scale-17 Score	The Hamilton Depression Scale-17 is a clinician-rated scale. Higher scores indicate more severe depression.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Magnetic resonance imaging (MRI) images	The MRI images contains resting, multi-tasks related, and structural states.	Baseline (preoperative)
Change in memory	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.	Baseline (preoperative),6 months or 12 months
Change in impulsivity and compulsivity	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.	Baseline (preoperative),6 months or 12 months
Change in Young Manic Rating Scale(YMRS)	The YMRS is a 11-item rating scale used to evaluate manic symptoms. Higher score indicates more severe mania.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Changes in SF-36 score	The 36-Item Short Form Survey (SF-36) is used to measure the quality of life. The higher score means higher quality of life.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Changes in WHOQOL-BREF score	The WHOQOL-BREF is used to measure the quality of life. The higher score means higher quality of life.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Changes in Q-LES-Q-SF score	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.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Changes in PSQI score	The pittsburgh sleep quality index (PSQI) is used to measure the quality and patterns of sleep. Higher score means poorer quality of sleep.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Changes in PSS-10 score	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.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Changes in PANAS score	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.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Change in Sheehan Disability Scale	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.	Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: University of Cambridge
• Investigators: Principal Investigator: Bomin Sun, PhD, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Valerie Voon, PhD, University of Cambridge

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 10, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 11, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 11, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2019 NAc VIC DBS OCD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No