StrokeNCT06322797
The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement
A study testing rTMS in people with Stroke, run by MinYoung Kim, MD, PhD at 1 site in South Korea.
Trial summary
A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2022to 31 Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 20 years of age
- Patients 3 months or more after stroke onset
- Patients with NIHSS score of 1 or more to 20 or less
- After hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate and agrees in writing to abide by the precautions
- Exclusion Criteria: Patients who fall under one or more of the following conditions are not eligible to participate in the study.
- Patients with systemic infectious disease at the time of participation in the clinical trial
Show all 13Show fewer
- In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian
- Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition
- Other cases where the researcher determines that participation in this clinical trial is not appropriate
- Those who are contraindicated in repetitive transcranial magnetic stimulation A. When metal materials (deep brain stimulation electrode, brain aneurysm clip, cardiac pacemaker, etc.) are in the body B. Uncontrolled epilepsy (epilepsy), patients with psychiatric disorders
- Pregnant, lactating women and patients with potential for pregnancy
- Patients with contraindications for imaging tests
- Those who have undergone cerebral surgery due to past or current related medical history
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine, CHA Bundang Medical Center
Seongnam, 13496
MinYoung Kim, MD,PhD, 82-31-780-2954 ext. 2954, parkmijin@chamc.co.kr
About this study
Official title: A Randomized, Controlled, Patient- and Assessor- Blinded, Exploratory Clinical Trial to Search the Stimulation Site for Repetitive Transcranial Magnetic Stimulation (rTMS) That Improves Upper Extremity Function After Stroke
A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke.
Read the detailed description
Some studies related to rTMS for the recovery of motor function (upper and lower extremity functions) after stroke are being conducted, and the clear mechanism has not been elucidated. It is known that function is restored through various neurophysiological changes.
However, there are not many studies on rTMS in the chronic stroke period, 3 months after the onset of stroke recovery, which is slow, and among them, there is no established standard for which part of the brain should be stimulated for treatment.
Recently, techniques for finding brain regions that are activated when performing a specific action through an imaging technique called fMRI (Functional Magnetic Resonance Imaging) are being used in various fields.
Based on the idea in this regard, recent studies have been conducted that the effect of rTMS treatment is better than the existing method when fMRI is used to identify the brain regions involved in the movement of the upper and lower extremities.
The purpose of this study is to evaluate the safety and efficacy on upper extremity function after stroke using fMRI and rTMS.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. First, the resting motor threshold was measured for each patient. At the lowest stimulus output, a stimulus was applied to the M1 cortex of the uninjured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb. The resting motor threshold was defined as the intensity required to generate a motor-induced potential of > 50 uV in the contralateral abductor pollicis brevis muscle at least 5 out of 10 times with 30 s of inter-stimulus time interval.
Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min.
rTMSDevice
Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. After identifying the brain site that is activated during finger tapping during fMI, Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min. the resting motor threshold was measured for each patient at target brain site.
ShamDevice
In Sound Mode, no actual stimulation is applied, and 20 minutes of treatment is performed like other experimental groups.
| Study group | Role | What they receive |
|---|---|---|
| rTMS over the M1 cortex of the injured hemisphere localized by motor action potential | Experimental | Experimental A group : rTMS was administered by trained physicians over the M1 cortex of the injured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb. Receives: Device: rTMS |
| rTMS over the specific site of the injured hemisphere localized by fMRI | Experimental | Experimental B group : rTMS was administered by trained physicians over the specific site which is after checking the brain site activated during finger tapping during fMRI imaging, target coordinates are set based on the 10-20 EEG system coordinate system in the taken MRI image. Receives: Device: rTMS |
| Sham group | Sham comparator | Sham group: shame rTMS( sound mode) is applied over the M1 cortex of the injured hemisphere which is the site that caused the largest visible twitch in the participant's thumb when stimulation is applied Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fugl-Meyer Assessment
The difference in the FMA (Fugl-Meyer Assessment) between the three groups at baseline, 30 days and 90 days was confirmed by comparing differences.[0~66 for each arm] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Secondary outcomes (23)
Change of Range of motion
The difference in the ROM(Range of motion between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.
Measured: Baseline - 1month - 3months
Change of Berg Balance Scale
The difference in the BBS (Berg Balance Scale) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~56] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Motor Assessment Scale
The difference in the MAS (Motor Assessment Scale) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~54] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Trunk Imbalance Scale
The difference in the TIS (Trunk Imbalance Scale) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~23] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Functional Ambulation Category
The difference in the FAC (Functional Ambulation Category) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~5] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Time up and go
The difference in the TUG (Time up and go) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. (The lower values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Manual muscle Test
The difference in the MMT (Manual muscle test) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~5 for each muscle] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Action reach arm test
The difference in the ARAT(Action reach arm test) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~57] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Jebsen taylor hand function test
The difference in the Jebsen taylor hand function test between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. (The lower values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Functional Independence Measure
The difference in the FIM (Functional Independence Measure) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~126] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Modified Barthel index
The difference in the MBI (Modified Barthel index) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~100] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of National Institutes of Health Stroke Scale
The difference in the NIHSS (National Institutes of Health Stroke Scale) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.[0~42] (The lower values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Korean Mini Mental State Exam
The difference in the K-MMSE (Korean Mini Mental State Exam) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. [0~30] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Clinical Dementia Rating
The difference in the CDR(clinical dementia rating) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. [0~5] (The lower values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Global Deterioration Scale
The difference in the GDS(Global Deterioration Scale) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. [0~7] (The lower values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Geriatric Depression Scale
The difference in the GDSd(Geriatric Depression Scale) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. [0~30] (The lower values represent a better outcome.)
Measured: Baseline - 1month - 3months
Change of Brain imaging
The difference in the Brain imaging (functional brain MRI) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. (Only in Experimental B group)
Measured: Baseline - 1month - 3months
Change of Electroencephalography
The difference in the Electroencephalography between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. ( Band power of the multiple brain sites based on the 10-20 EEG system [Frontal (Fp1, Fp2, F7, F3, Fz, F4, F8), Central (C3, Cz, C4),Temporal (T3,T4,T5,T6), Parietal (P3, Pz, P4), Occipital (O1, O2)] measured in the various EEG frequency bands [(Delta (1~4Hz), Theta (4~8Hz), Alpha1 (8~10Hz), Alpha2 (10~12Hz), Beta1 (12~15Hz), Beta2 (15~20Hz), Beta3 (20~30Hz), Gamma (30~45Hz)]
Measured: Baseline - 1month - 3months
Change of Evoked Potential
The difference in the EP(Evoked Potential) Study between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.
Measured: Baseline - 1month - 3months
Changes in test results of WBC(/uL), RBC(/uL), , Hct(%), PLT(/uL), Hgb(g/dL)
The difference in the Laboratory test WBC(/uL), RBC(/uL), , Hct(%), PLT(/uL), Hgb(g/dL) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.
Measured: Baseline - 1month - 3months
Changes in test results of CRP (mg/dL), glucose (mg/dL), BUN (mg/dL), creatinine (mg/dL), total cholesterol (mg/dL)
The difference in the Laboratory test [CRP(mg/dL), Glucose(mg/dL), BUN(mg/dL) , Creatinine(mg/dL), Total choliesterol(mg/dL)] between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.
Measured: Baseline - 1month - 3months
Changes in test results of AST(IU/L), ALT(IU/L)
The difference in the Laboratory test [AST(IU/L), ALT(IU/L)] between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences.
Measured: Baseline - 1month - 3months
Change of Motricity index
The difference in the MI(Motricity index) between the three groups at baseline, 30 days, and 90 days was confirmed by comparing differences. [0~100] (The higher values represent a better outcome.)
Measured: Baseline - 1month - 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start19 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinYoung Kim, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
- Investigators
- Kim MinYoung, M.D., Ph.D., Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322797
- Sponsor's protocol ID
- rTMSinStroke
- Status last verified
- Mar 2024
- First submitted
- 12 Jul 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Patient- and Assessor- Blinded, Exploratory Clinical Trial to Search the Stimulation Site for Repetitive Transcranial Magnetic Stimulation (rTMS) That Improves Upper Extremity Function After Stroke
- ClinicalTrials.gov ID
- NCT06322797
- Acronym / sponsor ID
- rTMSinStroke
- Conditions
- Stroke
- Keywords
- Stroke, Functional Magnetic Resonance Imaging, Repetitive transcranial magnetic stimulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- MinYoung Kim, MD, PhDUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Mar 2024 (actual)
- 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.
A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke.
Detailed description
Some studies related to rTMS for the recovery of motor function (upper and lower extremity functions) after stroke are being conducted, and the clear mechanism has not been elucidated. It is known that function is restored through various neurophysiological changes.
However, there are not many studies on rTMS in the chronic stroke period, 3 months after the onset of stroke recovery, which is slow, and among them, there is no established standard for which part of the brain should be stimulated for treatment.
Recently, techniques for finding brain regions that are activated when performing a specific action through an imaging technique called fMRI (Functional Magnetic Resonance Imaging) are being used in various fields.
Based on the idea in this regard, recent studies have been conducted that the effect of rTMS treatment is better than the existing method when fMRI is used to identify the brain regions involved in the movement of the upper and lower extremities.
The purpose of this study is to evaluate the safety and efficacy on upper extremity function after stroke using fMRI and rTMS.
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 |
|---|---|---|
| rTMS over the M1 cortex of the injured hemisphere localized by motor action potential | Experimental | Device: rTMSExperimental A group : rTMS was administered by trained physicians over the M1 cortex of the injured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb. |
| rTMS over the specific site of the injured hemisphere localized by fMRI | Experimental | Device: rTMSExperimental B group : rTMS was administered by trained physicians over the specific site which is after checking the brain site activated during finger tapping during fMRI imaging, target coordinates are set based on the 10-20 EEG system coordinate system in the taken MRI image. |
| Sham group | Sham comparator | Device: ShamSham group: shame rTMS( sound mode) is applied over the M1 cortex of the injured hemisphere which is the site that caused the largest visible twitch in the participant's thumb when stimulation is applied |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults over 20 years of age
- Patients 3 months or more after stroke onset
- Patients with NIHSS score of 1 or more to 20 or less
- After hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate and agrees in writing to abide by the precautions
- Exclusion Criteria: Patients who fall under one or more of the following conditions are not eligible to participate in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| rTMSStimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. First, the resting motor threshold was measured for each patient. At the lowest stimulus output, a stimulus was applied to the M1 cortex of the uninjured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb. The resting motor threshold was defined as the intensity required to generate a motor-induced potential of > 50 uV in the contralateral abductor pollicis brevis muscle at least 5 out of 10 times with 30 s of inter-stimulus time interval. Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min. | Device | rTMS over the M1 cortex of the injured hemisphere localized by motor action potential |
| rTMSStimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. After identifying the brain site that is activated during finger tapping during fMI, Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min. the resting motor threshold was measured for each patient at target brain site. | Device | rTMS over the specific site of the injured hemisphere localized by fMRI |
| ShamIn Sound Mode, no actual stimulation is applied, and 20 minutes of treatment is performed like other experimental groups. | Device | Sham group |
Primary outcome
Change of Fugl-Meyer Assessment
Time frame: Baseline - 1month - 3months
The difference in the FMA (Fugl-Meyer Assessment) between the three groups at baseline, 30 days and 90 days was confirmed by comparing differences.[0~66 for each arm] (The higher values represent a better outcome.)
23 secondary outcomes
Change of Range of motion
Time frame: Baseline - 1month - 3months
Change of Berg Balance Scale
Time frame: Baseline - 1month - 3months
Change of Motor Assessment Scale
Time frame: Baseline - 1month - 3months
Change of Trunk Imbalance Scale
Time frame: Baseline - 1month - 3months
Change of Functional Ambulation Category
Time frame: Baseline - 1month - 3months
Change of Time up and go
Time frame: Baseline - 1month - 3months
Change of Manual muscle Test
Time frame: Baseline - 1month - 3months
Change of Action reach arm test
Time frame: Baseline - 1month - 3months
Change of Jebsen taylor hand function test
Time frame: Baseline - 1month - 3months
Change of Functional Independence Measure
Time frame: Baseline - 1month - 3months
Change of Modified Barthel index
Time frame: Baseline - 1month - 3months
Change of National Institutes of Health Stroke Scale
Time frame: Baseline - 1month - 3months
Change of Korean Mini Mental State Exam
Time frame: Baseline - 1month - 3months
Change of Clinical Dementia Rating
Time frame: Baseline - 1month - 3months
Change of Global Deterioration Scale
Time frame: Baseline - 1month - 3months
Change of Geriatric Depression Scale
Time frame: Baseline - 1month - 3months
Change of Brain imaging
Time frame: Baseline - 1month - 3months
Change of Electroencephalography
Time frame: Baseline - 1month - 3months
Change of Evoked Potential
Time frame: Baseline - 1month - 3months
Changes in test results of WBC(/uL), RBC(/uL), , Hct(%), PLT(/uL), Hgb(g/dL)
Time frame: Baseline - 1month - 3months
Changes in test results of CRP (mg/dL), glucose (mg/dL), BUN (mg/dL), creatinine (mg/dL), total cholesterol (mg/dL)
Time frame: Baseline - 1month - 3months
Changes in test results of AST(IU/L), ALT(IU/L)
Time frame: Baseline - 1month - 3months
Change of Motricity index
Time frame: Baseline - 1month - 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Kim MinYoung, M.D., Ph.D. principal investigator
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Stroke, run by MinYoung Kim, MD, PhD 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 13 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim MinYoung, M.D., Ph.D. (82-31-780-6281, kmin@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Fugl-Meyer Assessment (time frame: Baseline - 1month - 3months). 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 21 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.