Back to resultsDeep Brain Stimulation of NAc/ALIC to Prevent Treatment-Refractory Obsessive Compulsive Disorder
Primary Purpose
Obsessive Compulsive Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deep brain stimulation
Fluoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, Deep Brain Stimulation, Nucleus accumbens
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD;
- Duration of illness: min. 5 year;
- 18 years old <Age <60 years old;
- Severe form of OCD, as evidenced by: a score≥25 on the Y-BOCS, a score > 4 on the CGI scale, a score≤40 on the GAF ("global assessment of functioning).
- All patients were lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least four different medications, lack of response to CBT (Cognitive Behaviour Therapy)over the course of 1 year of therapy or after 20 sessions.
- Normal cognitive status and ability to understand and comply with instructions for multiple therapies.
- Good overall health.
Exclusion Criteria:
- Present or past history of psychotic symptoms.
- Severe personality disorders;
- Any clinically significant neurological disorder or medical illnesses affect ;
- brain function, other than motor tics or Gilles de la Tourette syndrome;
- Patient currently treated with anticoagulant or antiplatelet drug;
- Patient with contraindication for surgery or anesthesia;
- Inability to undergo awaked operation;
- Infection, coagulopathy, significant cardiac or other medical risk factors for surgery;
- Patient with contraindication for MRI scanning (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), abnormal brain MRI or serious inter current disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Deep Brain Stimulation
Standard Control
Arm Description
Continuous deep brain stimulation of bilateral nucleus accumbens
Fluoxetine
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary Outcome Measures
Clinical Global Impression (CGI)
Global assessment of functioning (GAF)
The Hamilton Anxiety Scale (HAM-A)
The Hamilton Rating Scale for Depression (HAM-D)
Sheehan Disability Scale (SDS)
Event related potentials(ERPs)
local field potential(LFP)
Change in two static positron emission tomography(PET) images study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02601677
Brief Title
Deep Brain Stimulation of NAc/ALIC to Prevent Treatment-Refractory Obsessive Compulsive Disorder
Official Title
Deep Brain Stimulation of Nucleus Accumbens/Anterior Limb of Internal Capsule to Prevent Treatment-Refractory Obsessive Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nucleus accumbens/anterior limb of internal capsule play important roles in the process of treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively prevent the disorder.
Detailed Description
Obsessive-compulsive disorder (OCD) is characterized by obsessions (persistent thoughts) and compulsions (repetitive ritualistic behaviour). Core symptoms of OCD cause remarkable distress and often perceived as inappropriate. The prevalence of OCD in the general population is estimated between 1% and 3%. It is a psychiatric illness that can lead to chronic functional impairment. Treatment options for OCD include cognitive behavioural therapy (CBT) and/or pharmacotherapy. Even when the best treatment options are used, approximately 10% of these patients remain severely affected and are considered therapy-refractory resulting in marked suffering and impairment in self-care, work and social life. More recently, deep brain stimulation (DBS) has been investigated as a therapy for refractory OCD, and the procedure was granted a limited humanitarian device exemption by the FDA in 2009. For these patients, deep brain stimulation (DBS), a neurosurgical treatment that involves stereotactic implantation of electrodes in specific deep-seated brain regions, has emerged as a new treatment option.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive Compulsive Disorder, Deep Brain Stimulation, Nucleus accumbens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Continuous deep brain stimulation of bilateral nucleus accumbens
Arm Title
Standard Control
Arm Type
Active Comparator
Arm Description
Fluoxetine
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation
Intervention Description
Deep brain stimulation of bilateral Nucleus accumbens/Anterior Limb of Internal Capsule
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI)
Time Frame
6 month
Title
Global assessment of functioning (GAF)
Time Frame
6 month
Title
The Hamilton Anxiety Scale (HAM-A)
Time Frame
6 month
Title
The Hamilton Rating Scale for Depression (HAM-D)
Time Frame
6 month
Title
Sheehan Disability Scale (SDS)
Time Frame
6 month
Title
Event related potentials(ERPs)
Time Frame
Baseline,3 month,6 month and 12 month
Title
local field potential(LFP)
Time Frame
in surgery,7 days after surgery
Title
Change in two static positron emission tomography(PET) images study
Time Frame
Baseline and 6month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD;
Duration of illness: min. 5 year;
18 years old <Age <60 years old;
Severe form of OCD, as evidenced by: a score≥25 on the Y-BOCS, a score > 4 on the CGI scale, a score≤40 on the GAF ("global assessment of functioning).
All patients were lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least four different medications, lack of response to CBT (Cognitive Behaviour Therapy)over the course of 1 year of therapy or after 20 sessions.
Normal cognitive status and ability to understand and comply with instructions for multiple therapies.
Good overall health.
Exclusion Criteria:
Present or past history of psychotic symptoms.
Severe personality disorders;
Any clinically significant neurological disorder or medical illnesses affect ;
brain function, other than motor tics or Gilles de la Tourette syndrome;
Patient currently treated with anticoagulant or antiplatelet drug;
Patient with contraindication for surgery or anesthesia;
Inability to undergo awaked operation;
Infection, coagulopathy, significant cardiac or other medical risk factors for surgery;
Patient with contraindication for MRI scanning (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), abnormal brain MRI or serious inter current disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-dong Gao, M.D.
Phone
+86 29 84777435
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xue-lian Wang, M.D.
Phone
+86 29 84777284
Email
wxlian@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Deep Brain Stimulation of NAc/ALIC to Prevent Treatment-Refractory Obsessive Compulsive Disorder
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