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

A Randomized Clinical Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive-Compulsive Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Continuous theta burst stimulation (cTBS); Device: shame rTMS

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).

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Continuous theta burst stimulation (cTBS); 50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
Experimental: 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.	Device: Continuous theta burst stimulation (cTBS); 50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
Experimental: 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.	Device: Continuous theta burst stimulation (cTBS); 50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
Sham Comparator: Group4: shame rTMS; The sham rTMS will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: RenJi Hospital; Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 25, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: SMHC-OCD-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No