Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder

Shanghai Mental Health Center

Status: Completed

Conditions: Obsessive-Compulsive Disorder

Treatments: Device: shame rTMS; Device: Continuous theta burst stimulation (cTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03649685

SMHC-OCD-003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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53 participants in 4 patient groups

Group1: rTMS(bilateral SMA)

Active Comparator group

Description:

Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.

Treatment:

Device: Continuous theta burst stimulation (cTBS)

Group2: rTMS(right DLPFC)

Experimental group

Description:

Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC once a day, 5 days/week, for 4 weeks.

Treatment:

Device: Continuous theta burst stimulation (cTBS)

Group3: rTMS(right DLPFC+bilateral SMA)

Experimental group

Description:

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.

Treatment:

Device: Continuous theta burst stimulation (cTBS)

Group4: shame rTMS

Sham Comparator group

Description:

The sham rTMS will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.

Treatment:

Device: shame rTMS