CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Transcranial Magnetic Stimulation (active) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00529308
NCT00529308Phase 2Completed

Transcranial Magnetic Stimulation for Individuals With Tourette's Syndrome

Yale University·interventional·Posted Sep 14, 2007·Updated Feb 21, 2019

In Brief

A Phase 2 clinical trial evaluating Transcranial Magnetic Stimulation (active) and Transcranial Magnetic Stimulation (sham) for Tourette Syndrome. Completed, enrolled 20 participants across 2 sites.

Detailed Summary

This study will evaluate the clinical efficacy of 1 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the supplementary motor area (SMA) in Tourette's Syndrome (TS) 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 TS. The investigators will administer neuropsychological tests to demonstrate that SMA targeted rTMS can be administered safely without significant impairments of cognitive or motor functioning. The investigators hypothesize that: 1. Compared to sham (placebo), active rTMS will improve symptoms of TS as assessed with the Yale Global Tic Severity Scale (Y-GTSS) 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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartJul 1, 2007
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.8 years ago

Interventions

Transcranial Magnetic Stimulation (active)device

Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.

Transcranial Magnetic Stimulation (sham)device

Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.