Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorders (rTMS-OCD)

July 29, 2015 updated by: Eman M. Khedr, Assiut University

Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive-Compulsive Disorders: Double Blind Randomized Clinical Trial

Objectives.-Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive stimulation methods that became widely used as therapeutic tools in neuropsychiatric research. The aim of this study is to Evaluate the therapeutic impact of different frequencies of repetitive transcranial stimulation (1HZ, 10HZ) in OCD patients. Material and Methods; Forty five patients of OCD were participated in the study. All patients fulfilled the diagnostic criteria of DSM-IV-TR. The mean age of the patients was 27.1+4.5 years. Each patient was subjected to the following: Yale-Brown obsessive compulsive scale (Y-BOCS), Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression - Severity scale (CGI-S). The patients were randomly classified into three equal groups using closed envelop: 1st group received 1 Hz rTMS at 100% of the RMT, 2nd group received 10 Hz rTMS with intensity of 100% of the RMT and 3rd group was sham group received the sham stimulation with a total 2000 pulses every day for each group for 10 sessions. Follow up of the patients using the same previous scales after the end of sessions and 3 months later.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients fulfilled the diagnostic criteria of DSM-IV-TR

Exclusion Criteria:

  • Patients with comorbid psychiatric disorder .

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1: Real rTMS-1 Hz
Included 15 patients, they received 1 Hz rTMS with intensity of 100% of the RMT continuous with total 2000 applied in 200 trains, each of 10 pulses, with 5 seconds intertrain interval
Procedure: rTMS-1Hz
Active Comparator: Group 2: Real rTMS-10 Hz
Included 15 patients, they received 10 Hz rTMS with intensity of 100% of the RMT applied in 10 trains, each of them 200 pulses, with 20 seconds intertrain interval
Procedure: rTMS-10 Hz
Sham Comparator: Group 3: Sham rTMS
Included 15 patients; they received the same number of pulses 2000 pulse applied in 200 trains, each of 10 pulses, with 5 seconds intertrain interval, but coil was placed over the same area but perpendicular to the scalp.
Procedure: Sham rTMS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
changes of Y-BOCS
Time Frame: Base line and after 3 months
Yale-Brown obsessive compulsive scale (Y-BOCS). It is an observer-rated scale that measures the severity of OCD symptoms. It is not a diagnostic tool. It is formed of 2 subscales, one for obsessions and another for compulsions. Each subscale consists of 5 items; і) time spent in the symptoms, іі) interference from the symptoms, ііі) subjective distress from symptoms, іv) resistance over symptoms, v) control over symptom. Each of these is rated from 0 (no symptoms) to 4 (extreme symptoms). The total Y-BOCS score ranges between: 0-7 subclinical 8-15 mild 16-23 moderate 24-31 severe 32-40 extreme (Goodman et al., 1989).
Base line and after 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in HAM-A score
Time Frame: Base line and after 3 months
Hamilton Anxiety Rating Scale (HAM-A). The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms by Max Hamilton (1959), and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where 0-14,normal range; 15-28, mild to moderate anxiety; 29-42, severe anxiety; 43-56, very severe anxiety. The scale has been translated into Arabic by Lotfy Fatem (1994).
Base line and after 3 months
Changes in CGI-S score
Time Frame: Base line and after 3 months
Clinical Global Impression - Severity scale (CGI-S): It is a 7- point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. (Guy 1976). Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1,normal,not at all ill; 2,borderline mentally ill; 3,mildly ill; 4,moderately ill; 5,markedly ill; 6,severely ill; or 7, extremely ill. (Rush 2000).
Base line and after 3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • rTMS-OCD

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