Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | Baseline - 1month - 3months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline - 1month - 3months |
| Change of Berg Balance Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria: Patients who fall under one or more of the following conditions are not eligible to participate in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim MinYoung, M.D., Ph.D. | Contact | 82-31-780-6281 | kmin@cha.ac.kr | |
| Kim JongMoon, M.D. | Contact | 82-31-780-6281 | khan1013@chamc.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kim MinYoung, M.D., Ph.D. | CHA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, CHA Bundang Medical Center | Recruiting | Seongnam | 13496 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| rTMS | Device | 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. |
|
| Sham | Device | In Sound Mode, no actual stimulation is applied, and 20 minutes of treatment is performed like other experimental groups. |
|
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.)
| 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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.) | 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) | 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)] | 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. | 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. | 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. | 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. | 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.) | Baseline - 1month - 3months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |