rTMS in Aphasic Patients With Neuroimage Assessments

Study Overview
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Brief Summary
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The refinement of repetitive transcranial magnetic stimulation (rTMS) has highlighted its merit in terms of learning programs as a treatment for aftereffect augmentation. Nevertheless, the efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of compound bi-hemispheric stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement.

Detailed Description
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The efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of inhibitory or excitatory stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement

Official Title
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Synchronous rTMS and Computer-integrated Speech Training Applied in Aphasic Patients

Conditions
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Stroke, Aphasia

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation (rTMS)
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aphasic stroke in chronic stage (over 3 months) Exclusion Criteria: No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>repetitive transcranial magnetic stimulation (rTMS) intervention of contralesional 1Hz-rTMS for 10 daily sessions. | Device: repetitive transcranial magnetic stimulation (rTMS)<br>* undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions<br>|
| Sham Comparator: Sham stimulation<br>Sham treatment for 2-week inhibitory non-dominate hemisphere rTMS program. | Device: Sham stimulation<br>* 2-week inhibitory non-dominate hemisphere rTMS program<br>|
| Experimental: High frequency rTMS<br>High-frequency rTMS to ipsilesional region for 10 daily sessions. | Device: repetitive transcranial magnetic stimulation (rTMS)<br>* undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks | linguistic function assessment | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks | brain activity change in fMRI | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Aphasia, rTMS, Functional MRI, Speech training