Study of Sequentially Applied Repetitive Transcranial Magnetic Stimulation in Obsessive- Compulsive Disorders

September 5, 2018 updated by: Se Joo Kim, Severance Hospital

A Randomized, Controlled Study of Sequentially Applied Repetitive Transcranial Magnetic Stimulation in Obsessive- Compulsive Disorders

The purpose of study was to investigate possible therapeutic effects and safety of sequentially combined low-frequency repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (DLPFC) and supplementary motor area (SMA) in patients with treatment-resistant obsessive-compulsive disorder (OCD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric disorder characterized by repetitive, intrusive thoughts and time-consuming behavioral or mental acts. Many OCD patients who do not respond to conventional treatments experience severe distress and disruptions in their daily activities. Novel approaches including psychopharmacological therapy and surgical techniques for treatment-resistant OCD have been proposed. With recent advances in non-invasive technique for stimulating the cerebral cortex, repetitive transcranial magnetic stimulation (rTMS) has been proposed as a potential therapeutic approach for various psychiatric illnesses including OCD.

Because of contradictory findings and a lack of controlled trials in OCD, rTMS cannot be yet recommended as routine therapy for OCD. However, it may have a potential clinical effect as a putative add-on treatment for OCD and an alternative therapy for treatment-resistant OCD.

For useful clinical applications, it is very important to develop methods to enhance the efficacy of rTMS. There are a number of putative ways to do this, and one of them is sequentially combining two forms of stimulation which are considered to have potential therapeutic effects. More recently, the sequential application of two stimulation regimens (high-frequency left-side rTMS and low-frequency right-side rTMS to the prefrontal cortex) has been found to have a substantial therapeutic effect in patients with treatment-resistant major depression. Therefore, the investigation for a sequentially combining effect of both the right prefrontal and the SMA stimulation would be worthwhile in OCD patients.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei Univ. Health System Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OCD patients who had failed adequate trials (a lack of at least a 25% reduction in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) 15 after at least eight weeks of treatment) of at least two serotonin re-uptake inhibitors (SRI) and behavioral therapy.

Exclusion Criteria:

  • Subjects were excluded if:

    • they presented with a movement disorder other than a tic
    • any psychotic symptoms
    • other anxiety disorders
    • mental retardation
    • alcohol or other substance abuse within the last six months
    • a history of psychosurgery, encephalitis or significant head trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active stimulation

For the active group, rTMS over the right prefrontal cortex and the SMA was sequentially performed. The rTMS of the right dorsolateral prefrontal cortex was conducted at a point 5 cm anterior to the point at which the MT was determined, and it was administered at an intensity of 110% of the RMT, a frequency of 1 Hz, for 10 minutes, and with an inter-train interval of 2 minutes (1200 stimuli/d).

The vertex (Cz) was measured for each patient, and the SMA was defined at 15% of the distance between the inion and nasion anterior to Cz on the sagittal midline, according to the international 10-20 EEG system. The rTMS over the SMA was administered at an intensity of 100% of the RMT, a frequency of 1 Hz, for 10 minutes and with an inter-train interval of 2 minutes (1200 stimuli/d).
Device: repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)

For the active group, rTMS over the right prefrontal cortex and the SMA was sequentially performed. The rTMS of the right dorsolateral prefrontal cortex was conducted at a point 5 cm anterior to the point at which the MT was determined, and it was administered at an intensity of 110% of the RMT, a frequency of 1 Hz, for 10 minutes, and with an inter-train interval of 2 minutes (1200 stimuli/d).

The vertex (Cz) was measured for each patient, and the SMA was defined at 15% of the distance between the inion and nasion anterior to Cz on the sagittal midline, according to the international 10-20 EEG system. The rTMS over the SMA was administered at an intensity of 100% of the RMT, a frequency of 1 Hz, for 10 minutes and with an inter-train interval of 2 minutes (1200 stimuli/d).

For the sham group, the sham stimulation was applied with the coil angled at 45° from the scalp using the same parameters as the active stimulation group over the same area.

Other Names:
  • A Magstim rapid magnetic stimulator with a 70-mm figure-of-eight coil (Magstim Company Ltd, Whitland, UK) was used for treatment.
Sham Comparator: Sham stimulation
For the sham group, the sham stimulation was applied with the coil angled at 45° from the scalp using the same parameters as the active stimulation group over the same area.
Device: repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)

For the active group, rTMS over the right prefrontal cortex and the SMA was sequentially performed. The rTMS of the right dorsolateral prefrontal cortex was conducted at a point 5 cm anterior to the point at which the MT was determined, and it was administered at an intensity of 110% of the RMT, a frequency of 1 Hz, for 10 minutes, and with an inter-train interval of 2 minutes (1200 stimuli/d).

The vertex (Cz) was measured for each patient, and the SMA was defined at 15% of the distance between the inion and nasion anterior to Cz on the sagittal midline, according to the international 10-20 EEG system. The rTMS over the SMA was administered at an intensity of 100% of the RMT, a frequency of 1 Hz, for 10 minutes and with an inter-train interval of 2 minutes (1200 stimuli/d).

For the sham group, the sham stimulation was applied with the coil angled at 45° from the scalp using the same parameters as the active stimulation group over the same area.

Other Names:
  • A Magstim rapid magnetic stimulator with a 70-mm figure-of-eight coil (Magstim Company Ltd, Whitland, UK) was used for treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure for the study was score on the Y-BOCS. The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment (at 4 weeks)
Time Frame: baseline, week 1, week 2, and week 4
baseline, week 1, week 2, and week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcome measures were the scores of MADRS and HARS, to examine the effects on cognitive functions of rTMS, a computerized Stroop task was conducted and side effect checklist.
Time Frame: baseline, week 1, week 2, and week 4
baseline, week 1, week 2, and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Investigators

  • Principal Investigator: Se Joo Kim, M.D., Yonsei Univ. College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2006-0318

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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