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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02511392
Collaborator
(none)
45
3
17.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: rTMS-1Hz
  • Procedure: rTMS-10 Hz
  • Procedure: Sham rTMS
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive-Compulsive Disorders: Double Blind Randomized Clinical Trial
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. changes of Y-BOCS [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).

Secondary Outcome Measures

  1. Changes in HAM-A score [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).

  2. Changes in CGI-S score [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients fulfilled the diagnostic criteria of DSM-IV-TR
Exclusion Criteria:
  • Patients with comorbid psychiatric disorder .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eman M. Khedr, Clinical professor, Assiut University
ClinicalTrials.gov Identifier:
NCT02511392
Other Study ID Numbers:
  • rTMS-OCD
First Posted:
Jul 30, 2015
Last Update Posted:
Jul 30, 2015
Last Verified:
Jul 1, 2015

Study Results

No Results Posted as of Jul 30, 2015