CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Repetitive Transcranial Magnetic Stimulation (rTMS) +1 moredevice
Likely dose
rTMS: 30 min stimulus train, 1 Hz frequency, 110% motor threshold intensity, once daily 5 days/week for 4 weeksAI-extracted
Key inclusion· 3
  • Primary diagnosis of obsessive-compulsive disorder with Y-BOCS score ≥16 despite adequate serotonin reuptake inhibitor (SRI) trial of ≥12 weeks at therapeutic dosage (e.g., fluoxetine ≥60 mg/d, sertraline ≥200 mg/d, paroxetine ≥50 mg/d, fluvoxamine ≥250 mg/d, citalopram ≥60 mg/d, escitalopram ≥30 mg/d) and duration of index episode ≥1 year
  • Individuals intolerant of SRI medications at the specified class and dose for the specified duration may be included
  • Patients currently on OCD medication must be on stable dose(s) and continue under care of treating psychiatrist
Key exclusion· 13
  • Refractory OCD defined as non-response to clomipramine AND ≥2 SSRIs at adequate dose/duration AND cognitive behavior therapy (≥1/week for ≥8 weeks with documented exposure and homework)
  • Current major depressive disorder of moderate or severe intensity (CGI ≥4)
  • Lifetime history of bipolar disorder
  • Lifetime history of any psychotic disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00106249
NCT00106249Phase 2Completed

Treatment of Obsessive Compulsive Disorder (OCD) With Transcranial Magnetic Stimulation (TMS)

New York State Psychiatric Institute·interventional·Posted Mar 22, 2005·Updated Jan 27, 2017

In Brief

A Phase 2 clinical trial evaluating Repetitive Transcranial Magnetic Stimulation (rTMS) and Sham for Obsessive-Compulsive Disorder. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This study will evaluate the clinical efficacy of functional Magnetic Resonance Imaging (fMRI) guided 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied to the Supplementary Motor Area (SMA) in OCD patients who have not fully responded to conventional therapies. The investigators will collect TMS measures of motor cortex excitability to test whether rTMS restores normal levels of intracortical inhibition found to be deficient in OCD. The investigators hypothesize that: 1. Compared to sham (placebo), active rTMS will improve symptoms of OCD as assessed with the Yale Brown Obsessive Compulsive Scale (Y-BOCS) and Clinical Global Impression (CGI). 2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as reflected by increased intracortical inhibition, motor threshold, and cortical silent period, and by decreased intracortical facilitation, relative to pre-treatment baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2005
Enrollment StartNov 1, 2004
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 21.3 years ago

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)device

Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.

Shamdevice

Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.