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

Primary Purpose

Obsessive Compulsive Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rTMS-1Hz
rTMS-10 Hz
Sham rTMS
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorders

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with comorbid psychiatric disorder .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    Group 1: Real rTMS-1 Hz

    Group 2: Real rTMS-10 Hz

    Group 3: Sham rTMS

    Arm Description

    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

    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

    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.

    Outcomes

    Primary Outcome Measures

    changes of Y-BOCS
    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).

    Secondary Outcome Measures

    Changes in HAM-A score
    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).
    Changes in CGI-S score
    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).

    Full Information

    First Posted
    July 28, 2015
    Last Updated
    July 29, 2015
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02511392
    Brief Title
    Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorders
    Acronym
    rTMS-OCD
    Official Title
    Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive-Compulsive Disorders: Double Blind Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1: Real rTMS-1 Hz
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Group 2: Real rTMS-10 Hz
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Group 3: Sham rTMS
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    rTMS-1Hz
    Intervention Type
    Procedure
    Intervention Name(s)
    rTMS-10 Hz
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham rTMS
    Primary Outcome Measure Information:
    Title
    changes of Y-BOCS
    Description
    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).
    Time Frame
    Base line and after 3 months
    Secondary Outcome Measure Information:
    Title
    Changes in HAM-A score
    Description
    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).
    Time Frame
    Base line and after 3 months
    Title
    Changes in CGI-S score
    Description
    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).
    Time Frame
    Base line and after 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients fulfilled the diagnostic criteria of DSM-IV-TR Exclusion Criteria: Patients with comorbid psychiatric disorder .

    12. IPD Sharing Statement

    Learn more about this trial

    Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorders

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