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

NCT ID: NCT03649685

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2024-09-30

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).

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group1: rTMS(bilateral SMA)

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

Group Type: ACTIVE_COMPARATOR

Continuous theta burst stimulation (cTBS)

Intervention Type: DEVICE

50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses

Group2: rTMS(right DLPFC)

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

Group Type: EXPERIMENTAL

Continuous theta burst stimulation (cTBS)

Intervention Type: DEVICE

50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses

Group3: rTMS(right DLPFC+bilateral SMA)

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.

Group Type: EXPERIMENTAL

Continuous theta burst stimulation (cTBS)

Intervention Type: DEVICE

50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses

Group4: shame rTMS

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

Group Type: SHAM_COMPARATOR

shame rTMS

Intervention Type: 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.

Interventions

Continuous theta burst stimulation (cTBS)

50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses

Intervention Type: DEVICE

shame rTMS

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Zhen Wang

vice-president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Wang, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SMHC-OCD-003

Identifier Type: -

Identifier Source: org_study_id