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

Overview

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).

Full Title of Study: “Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder: Efficacy and Mechanism of Ventral Internal Capsue and Nucleus Accumbens”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in Yale-Brown Obsessive-Compulsive Scale-Self Report (Y-BOCS-SR) Score
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.
  • Adverse Events
    • Time Frame: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
  • Changes in Hamilton Anxiety Scale Score
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Baseline (preoperative)
    • The MRI images contains resting, multi-tasks related, and structural states.
  • Change in memory
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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 SF-36 score
    • Time Frame: 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 WHOQOL-BREF score
    • Time Frame: 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 Q-LES-Q-SF score
    • Time Frame: 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
    • Time Frame: 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 PSS-10 score
    • Time Frame: 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.
  • Changes in PANAS score
    • Time Frame: 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.
  • Change in Sheehan Disability Scale
    • Time Frame: 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.

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ruijin Hospital
  • Collaborator
    • University of Cambridge
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bomin Sun, Director of Functional Neurosurgery Department – Ruijin Hospital
  • Overall Official(s)
    • Bomin Sun, PhD, Principal Investigator, Shanghai Jiao Tong University School of Medicine
    • Valerie Voon, PhD, Principal Investigator, University of Cambridge
  • Overall Contact(s)
    • Chencheng Zhang, PhD, +086-18217122884, i@cczhang.org

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