CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 63 enrolled
Drug / intervention
Transcranial Magnetic Stimulation, Repetitivedevice
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/NCT00608582
NCT00608582Phase 1Completed
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Transcranial Magnetic Stimulation to Improve Speech

Boston University·interventional·Posted Feb 6, 2008·Updated Jan 31, 2017

In Brief

A Phase 1 clinical trial evaluating Transcranial Magnetic Stimulation, Repetitive for Aphasia and Cerebrovascular Stroke. Completed, enrolled 63 participants across 3 sites.

Detailed Summary

The purpose of this study is to examine whether repetitive transcranial magnetic stimulation (rTMS) can be used to improve speech in chronic stroke patients with aphasia. Aphasia patients can have problems with speech production. The rTMS procedure allows painless, noninvasive stimulation of human cortex from outside the head. Chronic aphasia patients have been observed in our functional magnetic resonance brain imaging studies to have excess brain activation in brain areas possibly related to language on the right side of the brain (opposite side to where the stroke took place). It is expected that suppression of activity in the directly targeted brain region will have an overall modulating effect on the neural network for naming (and propositional speech) and will result in behavioral improvement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAphasia, Cerebrovascular Stroke
CountriesUnited States
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD), Harvard Medical School (HMS and HSDM), University of Pennsylvania

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2008
Enrollment StartJul 1, 2002
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10.9 yearsPosted 18.4 years ago

Interventions

Transcranial Magnetic Stimulation, Repetitivedevice

10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.