Effects of rTMS Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia
NCT ID: NCT02591719
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2015-11-30
2023-10-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MagPro magnetic stimulator (HF rTMS)
Most activated area from fNIRS with language task: Perilesional Broca's area
MagPro 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
MagPro magnetic stimulator (sham)
Most activated area from fNIRS with language task: Perilesional Broca's area
MagPro 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
MagPro magnetic stimulator (LF rTMS)
Most activated area from fNIRS with language task: Contralesional homologs of Broca's area
MagPro 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
Interventions
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MagPro 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
MagPro 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
MagPro 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Nam-Jong Paik
Professor
Principal Investigators
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Nam-Jong Paik, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Locations
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Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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B-1507-308-006/P2
Identifier Type: -
Identifier Source: org_study_id
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