Effects of rTMS Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia

Study Overview
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Brief Summary
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The aim of this study is to assess the safety and clinical efficacy of high or low-frequency repetitive transcranial magnetic stimulation based on brain activation with functional near infrared spectroscopy in poststroke nonfluent aphasia patients.

Detailed Description
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In poststsroke aphasia rehabilitation, repetitive transcranial stimulation (rTMS) studies aimed to reinforce the activity of the brain regions in the left hemisphere. This goal can be achieved by using an excitatory protocol to reactivate the perilesional area or inhibitory protocol to reduce activities in the contralesional area. However, most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area. In the present pilot study, investigators will perform functional near-infrared spectroscopy (fNIRS) prior to rTMS treatment for selection of the most appropriate application of stimulation. Stimulation site and protocol (high frequency or low frequency rTMS) will be determined by activation pattern from the fNIRS findings with language task in individual patients.

Official Title
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Effects of Repetitive Transcranial Magnetic Stimulation Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia: A Pilot Study

Conditions
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Stroke, Aphasia

Intervention / Treatment
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* Device: High frequency rTMS
* Device: Low frequency rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 yrs old Right-handed Radiologically confirmed left hemisphere stroke Fluent in Korean First ever stroke More than 1 year from stroke onset Non-fluent (motor-dominant) aphasia Written informed consent Exclusion Criteria: Previous medical histories of stroke, cerebral vascular operation, seizure Patients with traumatic brain injury Unable to perform the language task Severe cognitive impairment (MMSE less than 16) Skin lesion in the stimulation site of scalp Metal implants in the body (cardiac pacemaker or aneurysm clip) Pregnancy, Breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High frequency rTMS<br>Most activated area from fNIRS with language task: Perileisional Broca's area | Device: High frequency rTMS<br>* Most activated area from fNIRS findings: Perileisional Broca's area, High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session<br>|
| Active Comparator: Low Frequency rTMS<br>Most activated area from fNIRS with language task: Contralesional homologs of Broca's area | Device: Low frequency rTMS<br>* Most activated area from fNIRS findings: Contralesional homologs of Broca's area, Low frequency rTMS (1Hz), Number of total stimuli: 1200, Location: Contralesional homologs of Broca's area (Pars triangularis), Intensity: 90% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BNT (Boston naming test) | speech evaluation tool for measuring the confrontational word retrieval function | Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WAB (Western aphasia battery) | speech evaluation tool for screening the presence, degree, and type of aphaisa | Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy) | 
| Laterality index (LI) | From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemisphereic Hbo values, respectively) | Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy) |