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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Shanghai 10th People's Hospital | OTHER |
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This study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rTMS) in obsessive-compulsive disorder (OCD) in OCD patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by EEG.
The purpose of study is to examine the efficacy of rTMS over different brain areas, including the bilateral supplement motor Area (SMA), the right dorsal lateral prefrontal cortex (DLPFC) and SMA+DLPFC in the treatment of OCD. 120 OCD patients will be randomized into four groups. Continuous theta burst stimulation (cTBS) stimulation will be performed once a day, five times a week, for four weeks. The investigators will assess improvement after four weeks of cTBS. Though the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS), the Barratt Impulsiveness Scale-11 (BIS-11), the Beck Depression Inventory(BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale(PSS), Pittsburgh sleep quality index(PSQI), the Obsessive-Compulsive Inventory-Revised(OCI-R) and side effects will be obtained by a trained investigator. The patients will also receive magnetic resonance imaging scan and electroencephalography (EEG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1: rTMS(bilateral SMA) | Active Comparator | Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks. |
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| Group2: rTMS(right DLPFC) | Experimental | Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC once a day, 5 days/week, for 4 weeks. |
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| Group3: rTMS(right DLPFC+bilateral SMA) | Experimental | Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC and bilateral SMA once a day, 5 days/week, for 4 weeks. |
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| Group4: shame rTMS | Sham Comparator | The sham rTMS will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous theta burst stimulation (cTBS) | Device | 50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale | The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS) | The DY-BOCS self-report is composed of an 88-item self-report checklist, designed to provide a detailed description of obsessions and compulsions that are divided into six different OC symptom dimensions. | Up to 6 months |
| The Barratt Impulsiveness Scale-11 (BIS-11) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhen Wang, PhD,MD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| shame rTMS | Device | The sham coil has been specifically developed to mimic the real one but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. |
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It is is an important tool for measuring impulsivity. |
| Up to 6 months |
| The Beck Depression Inventory(BDI) | It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression. | Up to 6 months |
| The Beck Anxiety Inventory (BAI) | It is a 21-item self-report inventory that is used for measuring the severity of anxiety. | Up to 6 months |
| State-trait Anxiety Inventory(STAI) | It has 20 items for assessing trait anxiety and 20 for state anxiety. | Up to 6 months |
| Perceived Stress Scale(PSS) | It is to measure the degree to which situations in one's life are appraised as stressful. | Up to 6 months |
| Pittsburgh sleep quality index(PSQI) | It is a self-report questionnaire that assesses sleep quality over a 1-month time interval. | Up to 6 months |
| The Obsessive-Compulsive Inventory-Revised(OCI-R) | It's a self-report designed to measure the principal dimensions which characterise obsessive-compulsive disorder. | Up to 6 months |
| side effects | It measures side effects including dizziness, headache, itching and so on. | Up to 6 months |