Aphasia, Stroke
Conditions
Keywords
Functional Near-Infrared Spectroscopy, Stroke, Aphasia, Repetitive Transcranial Magnetic Stimulation
Brief summary
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
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.
Interventions
DEVICEMagPro magnetic stimulator (HF rTMS)
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
DEVICEMagPro magnetic stimulator (sham)
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
DEVICEMagPro magnetic stimulator (LF rTMS)
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
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BNT (Boston Naming Test) | up to 2 weeks | speech evaluation tool for measuring the confrontational word retrieval function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia) | up to 6 weeks | 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' |
| 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) | up to 6 weeks | 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' |
| BNT (Boston Naming Test) | 4 weeks | speech evaluation tool for measuring the confrontational word retrieval function |
Countries
South Korea
Outcome results
None listed