Deep Brain Stimulation, Obsessive-Compulsive Disorder
Conditions
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).
Interventions
DEVICEDBS 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.
Sponsors
University of Cambridge
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Score | 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 | 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 | Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months | — |
| Changes in Hamilton Anxiety Scale Score | 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 | 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 | Baseline (preoperative) | The MRI images contains resting, multi-tasks related, and structural states. |
| Change in memory | 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 | 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 Yale-Brown Obsessive-Compulsive Scale-Self Report (Y-BOCS-SR) Score | 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. |
| Changes in SF-36 score | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Change in Young Manic Rating Scale(YMRS) | 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. |
Countries
China
Contacts
Primary ContactChencheng Zhang, PhD
Outcome results
None listed