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NCT00529308 · ClinicalTrials.gov registry record · Phase 2

Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette's Syndrome

A Phase 2 study of Tourette Syndrome, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
2
Study locations

NCT00529308 is a Phase 2 study of Tourette Syndrome that has completed, run by Yale University. The registered enrollment target is 20 participants, below the 86-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00529308, a Phase 2 study of Tourette Syndrome, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
2
Study locations

Study 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.

Conditions Studied

Tourette Syndrome

Interventions

  • DEVICE Transcranial Magnetic Stimulation (active)
  • DEVICE Transcranial Magnetic Stimulation (sham)

Study Locations (2)

Connecticut

  • Yale University School of Medicine - New Haven

New York

  • New York State Psychiatric Institute - New York

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-07
Est. Completion 2011-07
Phase Phase 2

Sponsor

Yale University

1,492 total trials

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What the Registry Record Tells You About NCT00529308

The ClinicalTrials.gov registry entry for NCT00529308 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (77% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tourette Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Transcranial Magnetic Stimulation (active) is the first listed.

NCT00529308 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Connecticut, New York.

Frequently Asked Questions

What is clinical trial NCT00529308 about?

NCT00529308 is a clinical study titled "Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette's Syndrome". 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 c...

What is the current status of trial NCT00529308?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2007-07. Estimated completion is 2011-07.

What conditions does trial NCT00529308 study?

This clinical trial studies the following conditions: Tourette Syndrome.

What interventions are being tested in trial NCT00529308?

The interventions under investigation include: Transcranial Magnetic Stimulation (active) (DEVICE), Transcranial Magnetic Stimulation (sham) (DEVICE).

Who is sponsoring clinical trial NCT00529308?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00529308 being conducted?

This trial has 2 study locations across Connecticut, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.