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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGChange 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
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
Adverse Events
Time frame: Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
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
Functional magnetic resonance imaging (fMRI) images
Time frame: Baseline (preoperative)
Quality of life: Global assessment of function
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Disability: WHO disability assessment 2.0
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Neurobehavior Task (Decision making task, such as Model task, IGT)
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Neurobehavior Task (Working memory task, such as N-back)
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
Disability: Sheehan Disability Scale
Time frame: Baseline (preoperative), 8 months, 12 months, 24 month
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
Change in Adult Temperament Questionnaire (ATQ-77) Score
Time frame: Baseline (preoperative), 8 months, 12month, 24 month
Change in Temperament and Character Inventory Revised (TRI-R) Score
Time frame: Baseline (preoperative), 8 months, 12month, 24 month
Cerebral glucose metabolism measured by PET-CT images
Time frame: Baseline (preoperative), 12 month
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