Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MagPro magnetic stimulator (HF rTMS) | Experimental | Most activated area from fNIRS with language task: Perilesional Broca's area |
|
| MagPro magnetic stimulator (sham) | Sham Comparator | Most activated area from fNIRS with language task: Perilesional Broca's area |
|
| MagPro magnetic stimulator (LF rTMS) | Active Comparator | Most activated area from fNIRS with language task: Contralesional homologs of Broca's area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagPro magnetic stimulator (HF rTMS) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BNT (Boston Naming Test) | speech evaluation tool for measuring the confrontational word retrieval function | up to 2 weeks |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nam-Jong Paik, MD, PhD | Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital | Seongnam-si | Korea, Gyeonggi-do | 463-707 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| MagPro magnetic stimulator (sham) | Device | 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 |
|
|
| MagPro magnetic stimulator (LF rTMS) | Device | 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 |
|
|
| 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 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided