Effects of rTMS Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia
Effects of Repetitive Transcranial Magnetic Stimulation Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Nov 2015
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2023
CompletedJuly 3, 2025
June 1, 2025
8 years
October 22, 2015
June 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BNT (Boston Naming Test)
speech evaluation tool for measuring the confrontational word retrieval function
up to 2 weeks
Secondary Outcomes (3)
WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)
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)
up to 6 weeks
BNT (Boston Naming Test)
4 weeks
Study Arms (3)
MagPro magnetic stimulator (HF rTMS)
EXPERIMENTALMost activated area from fNIRS with language task: Perilesional Broca's area
MagPro magnetic stimulator (sham)
SHAM COMPARATORMost activated area from fNIRS with language task: Perilesional Broca's area
MagPro magnetic stimulator (LF rTMS)
ACTIVE COMPARATORMost activated area from fNIRS with language task: Contralesional homologs of Broca's area
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nam-Jong Paik, MD, PhD
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 29, 2015
Study Start
November 1, 2015
Primary Completion
October 20, 2023
Study Completion
October 20, 2023
Last Updated
July 3, 2025
Record last verified: 2025-06