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

NCT03649685 | Completed

• 1 other identifier: SMHC-OCD-003
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)

  Up to 6 months

• The Barratt Impulsiveness Scale-11 (BIS-11)

  Up to 6 months

• The Beck Depression Inventory(BDI)

  Up to 6 months

• The Beck Anxiety Inventory (BAI)

  Up to 6 months

• State-trait Anxiety Inventory(STAI)

  Up to 6 months

Study Arms (4)

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.

Device: Continuous theta burst stimulation (cTBS)

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.

Device: Continuous theta burst stimulation (cTBS)

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.

Device: Continuous theta burst stimulation (cTBS)

Group4: shame rTMS

SHAM COMPARATOR

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

Device: shame rTMS

Interventions

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

Group1: rTMS(bilateral SMA); Group2: rTMS(right DLPFC); Group3: rTMS(right DLPFC+bilateral SMA)

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.

Group4: shame rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• RenJi Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Zhen Wang, PhD,MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: July 15, 2019
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-04

Locations

CN (1)