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

Ruijin Hospital20 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obsessive-Compulsive Disorder Deep Brain Stimulation

Interventions

DBS systemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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;

Locations (1)

Ruijin Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Adverse Events

Time frame: 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.

Central Contacts

Chencheng Zhang, PhD

CONTACT

+086-18217122884 i@cczhang.org

Data from ClinicalTrials.gov

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Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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