Back to resultsThe Efficacy and Mechanism of DBS in VIC and NAcc for Refractory OCD
Primary Purpose
Obsessive-Compulsive Disorder, Deep Brain Stimulation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DBS system
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of OCD with duration of at least 5 years;
- Severity rated as severe to extreme illness;
- Failed adequate trial of at least three specific serotonin reuptake inhibitor (SSRI) antidepressants;
- Failed augmentation with antipsychotic;
- Completed or failed to complete adequate trial of cognitive behavioural therapy for OCD;
- Stable medication regimen for one month before surgery;
- Signed informed consent;
Exclusion Criteria:
- Hoarding as a primary symptom;
- No other serious psychiatric disorder such as psychotic disorder;
- Drug or substance use disorder within 6 months except nicotine;
- Major Neurological/Medical condition;
- High suicide risk;
- Pregnancy or lactation;
- Contraindications to stereotactic surgery;
- Contraindications to MRI;
Sites / Locations
- Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bilateral surgical implantation of DBS system
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Adverse Events
Changes in Hamilton Anxiety Scale Score
The Hamilton Anxiety Scale is a clinician-rated scale. Higher scores indicate more severe anxiety.
Changes in Hamilton Depression Scale-17 Score
The Hamilton Depression Scale-17 is a clinician-rated scale. Higher scores indicate more severe depression.
Magnetic resonance imaging (MRI) images
The MRI images contains resting, multi-tasks related, and structural states.
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.
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.
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.
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.
Changes in WHOQOL-BREF score
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
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
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
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
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
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.
Full Information
NCT ID
NCT04228744
First Posted
January 5, 2020
Last Updated
January 11, 2020
Sponsor
Ruijin Hospital
Collaborators
University of Cambridge
1. Study Identification
Unique Protocol Identification Number
NCT04228744
Brief Title
The Efficacy and Mechanism of DBS in VIC and NAcc for Refractory OCD
Official Title
Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder: Efficacy and Mechanism of Ventral Internal Capsue and Nucleus Accumbens
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
University of Cambridge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Deep Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bilateral surgical implantation of DBS system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DBS system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score
Description
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 Outcome Measure Information:
Title
Change in Yale-Brown Obsessive-Compulsive Scale-Self Report (Y-BOCS-SR) Score
Description
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
Title
Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Score
Description
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
Title
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score
Description
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
Title
Adverse Events
Time Frame
Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Title
Changes in Hamilton Anxiety Scale Score
Description
The Hamilton Anxiety Scale is a clinician-rated scale. Higher scores indicate more severe anxiety.
Time Frame
Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Title
Changes in Hamilton Depression Scale-17 Score
Description
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
Title
Magnetic resonance imaging (MRI) images
Description
The MRI images contains resting, multi-tasks related, and structural states.
Time Frame
Baseline (preoperative)
Title
Change in memory
Description
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
Title
Change in impulsivity and compulsivity
Description
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
Title
Change in Young Manic Rating Scale(YMRS)
Description
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
Title
Changes in SF-36 score
Description
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
Title
Changes in WHOQOL-BREF score
Description
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
Title
Changes in Q-LES-Q-SF score
Description
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
Title
Changes in PSQI score
Description
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
Title
Changes in PSS-10 score
Description
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
Title
Changes in PANAS score
Description
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
Title
Change in Sheehan Disability Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of OCD with duration of at least 5 years;
Severity rated as severe to extreme illness;
Failed adequate trial of at least three specific serotonin reuptake inhibitor (SSRI) antidepressants;
Failed augmentation with antipsychotic;
Completed or failed to complete adequate trial of cognitive behavioural therapy for OCD;
Stable medication regimen for one month before surgery;
Signed informed consent;
Exclusion Criteria:
Hoarding as a primary symptom;
No other serious psychiatric disorder such as psychotic disorder;
Drug or substance use disorder within 6 months except nicotine;
Major Neurological/Medical condition;
High suicide risk;
Pregnancy or lactation;
Contraindications to stereotactic surgery;
Contraindications to MRI;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chencheng Zhang, PhD
Phone
+086-18217122884
Email
i@cczhang.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valerie Voon, PhD
Organizational Affiliation
University of Cambridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chencheng Zhang, PhD
Phone
86-18217122884
Email
i@cczhang.org
First Name & Middle Initial & Last Name & Degree
Bomin Sun, PhD
First Name & Middle Initial & Last Name & Degree
Valerie Voon, PhD
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Mechanism of DBS in VIC and NAcc for Refractory OCD
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