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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03649685
• Other study ID #: SMHC-OCD-003
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2022
• Source: Shanghai Mental Health Center
• Contact: Zhen Wang, PhD,MD
• Phone: +86 34773516
• Email: wangzhen[@]smhc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	RenJi Hospital, Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The Barratt Impulsiveness Scale-11 (BIS-11)	It is is an important tool for measuring impulsivity.	Up to 6 months
Secondary	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
Secondary	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
Secondary	State-trait Anxiety Inventory(STAI)	It has 20 items for assessing trait anxiety and 20 for state anxiety.	Up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	side effects	It measures side effects including dizziness, headache, itching and so on.	Up to 6 months