Back to resultsNovel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
deep brain stimulation system
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 65 years.
- A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V).
- Chronic: at least a 3-year history of OCD symptoms with psychosocial dysfunction
- Severity: a score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the Clinical Global Impression (CGI) scale of more than 4.
- Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45 or a score on Sheehan Disability Scale more than 24.
- Refractory: a lack of response to drug therapy after adequate administration, defined as more than two types of serotonin reuptake inhibitors at the maximum tolerated dose for more than 12 weeks. Adequate behavior therapy, defined as more than 20 sessions psychotherapy with experienced therapist.
- OCD medication regimen is stable for at least 4 weeks before enrollment.
Exclusion Criteria:
- Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0).
- Cluster A or B personality disorder according to DSM-IV-TR criteria, as assessed with the use of the Structured Clinical Interview II.
- A current severe major depressive episode, determined according to DSM-V criteria (as assessed with the use of the MINI 6.0.0) and defined by the Hamilton Depression Rating Scale-17 (HAMD) score of more than 20 and a risk of suicide.
- Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain, or contraindications to surgery or anesthesia.
Sites / Locations
- Shanghai Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active stimulation
Sham stimulation
Arm Description
Stimulator on followed by off
Stimulator off followed by on
Outcomes
Primary Outcome Measures
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
Secondary Outcome Measures
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score
Adverse Events
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Functional magnetic resonance imaging (fMRI) images
Quality of life: Global assessment of function
Disability: WHO disability assessment 2.0
Neurobehavior Task (Decision making task, such as Model task, IGT)
Neurobehavior Task (Working memory task, such as N-back)
Disability: Sheehan Disability Scale
Change in Obsessional beliefs questionnaire (OBQ-44) Score
Change in Adult Temperament Questionnaire (ATQ-77) Score
Change in Temperament and Character Inventory Revised (TRI-R) Score
Cerebral glucose metabolism measured by PET-CT images
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02590445
Brief Title
Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder
Official Title
Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most effective treatment for refractory OCD. However, the affecting area of traditional electrodes is limited and not specific to VC/VS. The investigators designed a novel electrode, 2 mental contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in ventral capsule simultaneously, which the investigators believe will be more effective due to better compatibly with anatomical features of target area. This trial is to evaluate the effectiveness and safety of this approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Active Comparator
Arm Description
Stimulator on followed by off
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Stimulator off followed by on
Intervention Type
Device
Intervention Name(s)
deep brain stimulation system
Primary Outcome Measure Information:
Title
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
Time Frame
Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Secondary Outcome Measure Information:
Title
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score
Time Frame
Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Title
Adverse Events
Time Frame
Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Title
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Time Frame
Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Title
Functional magnetic resonance imaging (fMRI) images
Time Frame
Baseline (preoperative)
Title
Quality of life: Global assessment of function
Time Frame
Baseline (preoperative), 8 months, 12 months, 24 month
Title
Disability: WHO disability assessment 2.0
Time Frame
Baseline (preoperative), 8 months, 12 months, 24 month
Title
Neurobehavior Task (Decision making task, such as Model task, IGT)
Time Frame
Baseline (preoperative), 8 months, 12 months, 24 month
Title
Neurobehavior Task (Working memory task, such as N-back)
Time Frame
Baseline (preoperative), 8 months, 12 months, 24 month
Title
Disability: Sheehan Disability Scale
Time Frame
Baseline (preoperative), 8 months, 12 months, 24 month
Title
Change in Obsessional beliefs questionnaire (OBQ-44) Score
Time Frame
Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Title
Change in Adult Temperament Questionnaire (ATQ-77) Score
Time Frame
Baseline (preoperative), 8 months, 12month, 24 month
Title
Change in Temperament and Character Inventory Revised (TRI-R) Score
Time Frame
Baseline (preoperative), 8 months, 12month, 24 month
Title
Cerebral glucose metabolism measured by PET-CT images
Time Frame
Baseline (preoperative), 12 month
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:
Age between 18 and 65 years.
A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V).
Chronic: at least a 3-year history of OCD symptoms with psychosocial dysfunction
Severity: a score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the Clinical Global Impression (CGI) scale of more than 4.
Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45 or a score on Sheehan Disability Scale more than 24.
Refractory: a lack of response to drug therapy after adequate administration, defined as more than two types of serotonin reuptake inhibitors at the maximum tolerated dose for more than 12 weeks. Adequate behavior therapy, defined as more than 20 sessions psychotherapy with experienced therapist.
OCD medication regimen is stable for at least 4 weeks before enrollment.
Exclusion Criteria:
Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0).
Cluster A or B personality disorder according to DSM-IV-TR criteria, as assessed with the use of the Structured Clinical Interview II.
A current severe major depressive episode, determined according to DSM-V criteria (as assessed with the use of the MINI 6.0.0) and defined by the Hamilton Depression Rating Scale-17 (HAMD) score of more than 20 and a risk of suicide.
Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain, or contraindications to surgery or anesthesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chencheng Zhang, MD
Phone
+8618217122884
Email
i@cczhang.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chencheng Zhang, MD
Phone
+8618217122884
Email
i@cczhang.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, MD, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chencheng Zhang, MD
Phone
+86 18217122884
Email
i@cczhang.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
20116047
Citation
Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. doi: 10.1016/j.biopsych.2009.11.028. Epub 2010 Feb 8.
Results Reference
background
PubMed Identifier
19005196
Citation
Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum In: N Engl J Med. 2009 Sep 3;361(10):1027.
Results Reference
background
PubMed Identifier
20921122
Citation
Denys D, Mantione M, Figee M, van den Munckhof P, Koerselman F, Westenberg H, Bosch A, Schuurman R. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch Gen Psychiatry. 2010 Oct;67(10):1061-8. doi: 10.1001/archgenpsychiatry.2010.122.
Results Reference
background
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Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder
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