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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228744
• Other study ID #: 2019 NAc VIC DBS OCD
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2020
• Source: Ruijin Hospital
• Contact: Chencheng Zhang, PhD
• Phone: +086-18217122884
• Email: i[@]cczhang.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	University of Cambridge

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Adverse Events		Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Secondary	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
Secondary	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
Secondary	Magnetic resonance imaging (MRI) images	The MRI images contains resting, multi-tasks related, and structural states.	Baseline (preoperative)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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