Obsessive-Compulsive Disorder Clinical Trial
Official title:
Study of Brain Network Mechanism for Individualized Accurate Target Positioning rTMS Treatment on Obsessive Compulsive Disorder
NCT number | NCT03393078 |
Other study ID # | AnhuiMU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2017 |
Est. completion date | December 1, 2020 |
Verified date | December 2021 |
Source | Anhui Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the treatment effect of repetitive transcranial magnetic stimulation on Obsessive-compulsive disorder, and the underlying neural mechanism by functional MRI.
Status | Completed |
Enrollment | 37 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: Patients met diagnostic criteria for obsessive-compulsive disorder using The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),confirmed by two clinical psychiatrist. Y-BOCS total severity scores =16(Simple forced obsessions or compulsions = 10),HAMA-14 scores < 14,HAMD-17 scores < 17; Raven's Standard Progressive Matrices(SPM) up to normal levels. After more than one anti-OCD drugs treatment for 8-10 weeks, no significant improvement in symptoms. Voluntarily participated and cooperated with the experiment. Exclusion Criteria: - History of significant head trauma or neurological disorders. Alcohol or drug abuse. Organic brain defects on T1 or T2 images. History of seizures or unexplained loss of consciousness. Family history of medication refractory epilepsy. recent aggression or other forms of behavioral dyscontrol. |
Country | Name | City | State |
---|---|---|---|
China | Anhui Medical University | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Anhui Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale | The Yale-Brown Obsessive Compulsive Scale is a test to rate the severity of obsessive-compulsive disorder symptoms, which measures obsessions separately from compulsions. The scale includes 10 items, the first 5 items are evaluated obsessions, the rest are assessments compulsions. Each item 0-4 points, a total of 40 points. The lower the score, the better the outcome. | up to 1 months | |
Secondary | Stop-Signal Task | Stop-Signal Task is a typical paradigm for measuring response inhibition and contains three indicators: Stop-signal reaction time (SSRT), the lower the SSRT value, the better the inhibition of reaction; Go task reaction time (GORT), GoRT is usually used in combination with SSRT to reveal the impaired of response inhibition; Stop-signal delays (SSD), SSD value increases, more difficult to inhibit successfully. | pre-treatment; 1 day post-treatment | |
Secondary | Task Switch | Task Switch is a paradigm for measuring cognitive flexibility, which involves the ability to unconsciously shift attention between one task and another and contains two indicators: task repeat and task switch. | pre-treatment; 1 day post-treatment | |
Secondary | Wisconsin CardSorting Test | The Wisconsin Card Sorting Test is a cognitive neuropsychological test, used to determine the abilities of human abstraction, concept formation, working memory and cognitive flexibility. Test measures a total of five indicators: Correct Response, Total Errors, Perseverative Responses, Perseverative Errors and Trials to complete 1st cat. | pre-treatment; 1 day post-treatment | |
Secondary | Hanoi Tower | Hanoi Tower is a test of planning and problem solving, that contains four indicators: total movement, Latency, 1st move reaction time and total reaction time. | pre-treatment; 1 day post-treatment | |
Secondary | Symptom improvement assessed by the Padua Inventory-Washington State University Revision | The Padua Inventory-Washington State University Revision is a self-rating scale for the severity of symptoms,that contains 5 subscales, 35 items. Each item 0-4 points, a total of 140 points. The lower the score, the better the outcome. | up to 1 months |
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