Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive-Compulsive Disorders: Double Blind Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 45
- Primary Endpoint
- changes of Y-BOCS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients fulfilled the diagnostic criteria of DSM-IV-TR
Exclusion Criteria
- •Patients with comorbid psychiatric disorder .
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Changes in HAM-A score(Base line and after 3 months)
- Changes in CGI-S score(Base line and after 3 months)
Investigators
Eman M. Khedr
Clinical professor
Assiut University