Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Device: Continuous theta burst stimulation (cTBS)Device: shame rTMS
- Registration Number
- NCT03649685
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- age>18 years old;
- DSM-5 criteria for OCD;
- Y-BOCS total score > or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI) and currently using adequate, stable dose of SRI at least 4 weeks. An adequate SRI trial is defined as treatment for at least 12 weeks on the SRI, that meets or exceeds the recommended dosage level for OCD;
- >or＝9 yrs education
- any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder
- serious suicide risk;
- the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
- any major medical disease;
- pregnancy or nursing of an infant;
- participation in current clinical study;
- current use of any investigational drug;
- TMS/DBS treatment at any point in their lifetime;
- history of long-time use of benzodiazepines
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group3: rTMS(right DLPFC+bilateral SMA) Continuous theta burst stimulation (cTBS) 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. Group1: rTMS(bilateral SMA) Continuous theta burst stimulation (cTBS) Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks. Group2: rTMS(right DLPFC) Continuous theta burst stimulation (cTBS) Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC once a day, 5 days/week, for 4 weeks. Group4: shame rTMS shame rTMS The sham rTMS will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
- Primary Outcome Measures
Name Time Method Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale Up to 6 months The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment
- Secondary Outcome Measures
Name Time Method The Barratt Impulsiveness Scale-11 (BIS-11) Up to 6 months It is is an important tool for measuring impulsivity.
The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS) Up to 6 months 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.
The Beck Anxiety Inventory (BAI) Up to 6 months It is a 21-item self-report inventory that is used for measuring the severity of anxiety.
The Beck Depression Inventory(BDI) Up to 6 months It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression.
side effects Up to 6 months It measures side effects including dizziness, headache, itching and so on.
State-trait Anxiety Inventory(STAI) Up to 6 months It has 20 items for assessing trait anxiety and 20 for state anxiety.
Perceived Stress Scale(PSS) Up to 6 months It is to measure the degree to which situations in one's life are appraised as stressful.
Pittsburgh sleep quality index(PSQI) Up to 6 months It is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The Obsessive-Compulsive Inventory-Revised(OCI-R) Up to 6 months It's a self-report designed to measure the principal dimensions which characterise obsessive-compulsive disorder.
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China