StrokeNCT02591719
Effects of rTMS Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia
A study testing MagPro magnetic stimulator (HF rTMS) and MagPro magnetic stimulator (LF rTMS) in people with Stroke and Aphasia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- MagPro magnetic stimulator (HF rTMS) and MagPro magnetic stimulator (LF rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, 463-707
About this study
Official title: Effects of Repetitive Transcranial Magnetic Stimulation Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia
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.
Read the 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.
- Being tested
- MagPro magnetic stimulator (HF rTMS), MagPro magnetic stimulator (sham), MagPro magnetic stimulator (LF rTMS)
- Keywords
- Functional Near-Infrared Spectroscopy, Stroke, Aphasia, Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro magnetic stimulator (HF rTMS)Device
Also called High frequency 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)Device
Also called Sham stimulation
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
Also called low frequency 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
| Study group | Role | What they receive |
|---|---|---|
| MagPro magnetic stimulator (HF rTMS) | Experimental | Most activated area from fNIRS with language task: Perilesional Broca's area Receives: Device: MagPro magnetic stimulator (HF rTMS) |
| MagPro magnetic stimulator (sham) | Sham comparator | Most activated area from fNIRS with language task: Perilesional Broca's area Receives: Device: MagPro magnetic stimulator (sham) |
| MagPro magnetic stimulator (LF rTMS) | Active comparator | Most activated area from fNIRS with language task: Contralesional homologs of Broca's area Receives: Device: MagPro magnetic stimulator (LF rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BNT (Boston Naming Test)
speech evaluation tool for measuring the confrontational word retrieval function
Measured: up to 2 weeks
Secondary outcomes (3)
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'
Measured: 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'
Measured: up to 6 weeks
BNT (Boston Naming Test)
speech evaluation tool for measuring the confrontational word retrieval function
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591719
- Sponsor's protocol ID
- B-1507-308-006/P2
- Status last verified
- Jun 2025
- First submitted
- 22 Oct 2015
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia
- ClinicalTrials.gov ID
- NCT02591719
- Acronym / sponsor ID
- B-1507-308-006/P2
- Keywords
- Functional Near-Infrared Spectroscopy, Stroke, Aphasia, Repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MagPro magnetic stimulator (HF rTMS) | Experimental | Device: MagPro magnetic stimulator (HF rTMS)Most activated area from fNIRS with language task: Perilesional Broca's area |
| MagPro magnetic stimulator (sham) | Sham comparator | Device: MagPro magnetic stimulator (sham)Most activated area from fNIRS with language task: Perilesional Broca's area |
| MagPro magnetic stimulator (LF rTMS) | Active comparator | Device: MagPro magnetic stimulator (LF rTMS)Most activated area from fNIRS with language task: Contralesional homologs of Broca's area |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-80 yrs old
- Right-handed
- Radiologically confirmed left hemisphere stroke within 6 months
- Fluent in Korean
- First ever stroke
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagPro magnetic stimulator (HF rTMS)Also: High frequency rTMSMost 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 | Device | MagPro magnetic stimulator (HF rTMS) |
| MagPro magnetic stimulator (sham)Also: Sham stimulationMost 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 | Device | MagPro magnetic stimulator (sham) |
| MagPro magnetic stimulator (LF rTMS)Also: low frequency rTMSMost 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 | Device | MagPro magnetic stimulator (LF rTMS) |
Primary outcome
BNT (Boston Naming Test)
Time frame: up to 2 weeks
speech evaluation tool for measuring the confrontational word retrieval function
3 secondary outcomes
WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)
Time frame: 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)
Time frame: up to 6 weeks
BNT (Boston Naming Test)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nam-Jong Paik, MD, PhD principal investigator
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagPro magnetic stimulator (HF rTMS) and MagPro magnetic stimulator (LF rTMS) in people with Stroke and Aphasia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BNT (Boston Naming Test) (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.