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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuous theta burst stimulation (cTBS)
shame rTMS
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Sham Comparator

Arm Label

Group1: rTMS(bilateral SMA)

Group2: rTMS(right DLPFC)

Group3: rTMS(right DLPFC+bilateral SMA)

Group4: shame rTMS

Arm Description

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

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
The Barratt Impulsiveness Scale-11 (BIS-11)
It is is an important tool for measuring impulsivity.
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.
The Beck Anxiety Inventory (BAI)
It is a 21-item self-report inventory that is used for measuring the severity of anxiety.
State-trait Anxiety Inventory(STAI)
It has 20 items for assessing trait anxiety and 20 for state anxiety.
Perceived Stress Scale(PSS)
It is to measure the degree to which situations in one's life are appraised as stressful.
Pittsburgh sleep quality index(PSQI)
It is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The Obsessive-Compulsive Inventory-Revised(OCI-R)
It's a self-report designed to measure the principal dimensions which characterise obsessive-compulsive disorder.
side effects
It measures side effects including dizziness, headache, itching and so on.

Full Information

First Posted
August 23, 2018
Last Updated
September 7, 2022
Sponsor
Shanghai Mental Health Center
Collaborators
RenJi Hospital, Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03649685
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder
Official Title
A Randomized Clinical Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive-Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
RenJi Hospital, Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group1: rTMS(bilateral SMA)
Arm Type
Active Comparator
Arm Description
Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
Arm Title
Group2: rTMS(right DLPFC)
Arm Type
Experimental
Arm Description
Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC once a day, 5 days/week, for 4 weeks.
Arm Title
Group3: rTMS(right DLPFC+bilateral SMA)
Arm Type
Experimental
Arm 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.
Arm Title
Group4: shame rTMS
Arm Type
Sham Comparator
Arm Description
The sham rTMS will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Continuous theta burst stimulation (cTBS)
Intervention Description
50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
Intervention Type
Device
Intervention Name(s)
shame rTMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
Description
The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)
Description
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.
Time Frame
Up to 6 months
Title
The Barratt Impulsiveness Scale-11 (BIS-11)
Description
It is is an important tool for measuring impulsivity.
Time Frame
Up to 6 months
Title
The Beck Depression Inventory(BDI)
Description
It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression.
Time Frame
Up to 6 months
Title
The Beck Anxiety Inventory (BAI)
Description
It is a 21-item self-report inventory that is used for measuring the severity of anxiety.
Time Frame
Up to 6 months
Title
State-trait Anxiety Inventory(STAI)
Description
It has 20 items for assessing trait anxiety and 20 for state anxiety.
Time Frame
Up to 6 months
Title
Perceived Stress Scale(PSS)
Description
It is to measure the degree to which situations in one's life are appraised as stressful.
Time Frame
Up to 6 months
Title
Pittsburgh sleep quality index(PSQI)
Description
It is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Time Frame
Up to 6 months
Title
The Obsessive-Compulsive Inventory-Revised(OCI-R)
Description
It's a self-report designed to measure the principal dimensions which characterise obsessive-compulsive disorder.
Time Frame
Up to 6 months
Title
side effects
Description
It measures side effects including dizziness, headache, itching and so on.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang, PhD,MD
Phone
+86 34773516
Email
wangzhen@smhc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang, PhD,MD
Phone
+86 64387250
Email
wangzhen@smhc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, PhD,MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Wang

12. IPD Sharing Statement

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

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