Effects of rTMS Based on Hemodynamic Activity for Language Recovery in Early Poststroke 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 repetitive transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.

Detailed Description
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Most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area. In the present randomized controlled trial, investigators will perform fNIRS prior to rTMS treatment to select the stimulation method. Stimulation site (perilesional or contralesional) and frequency (excitatory high or inhibitory low) will be determined by activation pattern from the fNIRS with language task in individual patients. The patient who shows a dominant neural activity at perilesional Broca's area on fNIRS scanning will be randomly allocated into two groups: high frequency stimulation group and sham stimulation group. If a patient shows a dominant neural activity at contralesional homologs of Broca's area on fNIRS scanning, the patient will be allocated to a low frequency stimulation group.

Official Title
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Effects of Repetitive Transcranial Magnetic Stimulation Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia: Randomized Controlled Trial

Conditions
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Stroke, Aphasia

Intervention / Treatment
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* Device: MagPro magnetic stimulator (HF rTMS)
* Device: MagPro magnetic stimulator (sham)
* Device: MagPro magnetic stimulator (LF 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 within 6 months Fluent in Korean First ever stroke 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MagPro magnetic stimulator (HF rTMS)<br>Most activated area from fNIRS with language task: Perilesional Broca's area | Device: MagPro magnetic stimulator (HF rTMS)<br>* Most activated area from fNIRS findings: Perilesional Broca's area. Use the true coil. 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>* Other names: High frequency rTMS;|
| Sham Comparator: MagPro magnetic stimulator (sham)<br>Most activated area from fNIRS with language task: Perilesional Broca's area | Device: MagPro magnetic stimulator (sham)<br>* Most activated area from fNIRS findings: Perilesional Broca's area. Use the sham coil. 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>* Other names: Sham stimulation;|
| Active Comparator: MagPro magnetic stimulator (LF rTMS)<br>Most activated area from fNIRS with language task: Contralesional homologs of Broca's area | Device: MagPro magnetic stimulator (LF rTMS)<br>* Most activated area from fNIRS findings: Contralesional homologs of Broca's area. Use the true coil. 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>* Other names: low frequency rTMS;|

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 | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia) | Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy' | up to 6 weeks | 
| LI (Laterality Index; From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemispheric HbO (oxyhemoglobin) or total Hb values, respectively) | Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy' | up to 6 weeks | 
| BNT (Boston Naming Test) | speech evaluation tool for measuring the confrontational word retrieval function | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Near-Infrared Spectroscopy, Stroke, Aphasia, Repetitive Transcranial Magnetic Stimulation