Combining Language Therapy With rTMS in Aphasia

Study Overview
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Brief Summary
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With the present RCT, the investigators aimed at finding an optimal protocol for the neurorehabilitation of chronic post-stroke aphasia by combining two promising methods, ILAT (Intensive language action therapy) and 1-Hz rTMS to the right-hemispheric homologue of the anterior language area of Broca (pars triangularis), thus taking advantage of recent research in speech and language sciences, neurorehabilitation and brain research.

Detailed Description
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New neuromodulation technologies, such as transcranial magnetic stimulation (TMS), are promising tools for neurorehabilitation, aphasia therapy included. Combined with behavioral techniques, Intensive Language-Action Therapy (ILAT), TMS could substantially amplify the beneficial effect of such behavioral therapy alone. In this randomized study of 17 subjects with post-stroke aphasia in the chronic stage will be studied the combined effect of ILAT and 1-Hz placebo-controlled navigated repetitive TMS (rTMS) to the right-hemispheric inferior frontal cortex (pars triangularis). Participant will be randomized to groups A and B. Participants in group A will receive a 2-week period of rTMS during naming training where they name pictures every ten second displayed on the screen, followed by 2-weeks of rTMS and naming combined with ILAT. Those in group B will receive the same behavioral therapy but TMS is replaced by sham stimulation. Language performance will be measured before, during and after the interventions for 3 months.

Official Title
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Combining Language Therapy With rTMS in Chronic Stage of Aphasia: A Randomized Controlled Trial

Conditions
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Aphasia

Intervention / Treatment
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* Behavioral: Intensive Language-Action Therapy (ILAT)
* Device: Repetitive navigated Transcranial Magnetic Stimulation during naming training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 75 years presence of a single clinically documented stroke chronic stage (at least 12 months post-stroke) aphasia documented using the WAB test no recurring utterances or severe global (total) aphasia residual ability to understand simple task instructions availability of information about medication right-handedness native speakers of Finnish. Exclusion Criteria: severe global (total) aphasia (Boston naming test less 3 points) neglect, agnosia, severe vision impairment or hearing loss severe attention or memory deficits left-handedness cardiac pacemaker or other stimulators diagnosis of severe diabetes or severe depression additional neurological diagnoses other interventions, including speech therapy, in the same time period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rTMS and naming combined with ILAT<br>Interventions: Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy | Behavioral: Intensive Language-Action Therapy (ILAT)<br>* ILAT includes communicative language games played in an interactive small-group setting. Three persons with aphasia and one therapist sit around a table and have picture cards in front of them. The card sets include two items of each object or action picture. All participants take turns in making verbal requests. There will be 5 daily sessions (3 hours per session) for two weeks.<br>Device: Repetitive navigated Transcranial Magnetic Stimulation during naming training<br>* Magnetic stimulation will delivered with a figure-of-eight cooled coil of Navigated Brain Stimulation System during picture naming training. The primary targeted area is the right pars triangularis. In each session, rTMS will be applied at 1-Hz for 20 minutes, 5 daily sessions per week for four weeks.<br>|
| Sham Comparator: sham rTMS and naming combined with ILAT<br>Interventions: sham Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy | Behavioral: Intensive Language-Action Therapy (ILAT)<br>* ILAT includes communicative language games played in an interactive small-group setting. Three persons with aphasia and one therapist sit around a table and have picture cards in front of them. The card sets include two items of each object or action picture. All participants take turns in making verbal requests. There will be 5 daily sessions (3 hours per session) for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Aphasia Battery | aphasia quotient (AQ) measurement | Change in AQ performed at weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Boston naming test | picture naming ability | Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion | 
| The Action naming test | picture naming ability | Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic aphasia, rehabilitation, randomized controlled trial (RCT)