Effects of High Frequency rTMS Combined Motor Learning on Upper Limb Motor Function in Subacute Stroke

Sponsor

Chungnam National University Sejong Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05176613

Collaborator

(none)

Enrollment

Arms

2.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study is to present the effect of a program combining high frequency repetitive transcranial magnetic stimulation with motor learning on upper limb motor function and grip strength and activities of daily motion in patients with subacute stroke.

Purpose : This study was to investigate the effects of high frequency repetitive transcranial magnetic stimulation combined with motor learning effects motor function and grip force for upper limbs and activities of daily living of subacute stroke patients.

Subjects : Thirty individuals with subacute stroke, satisfying the selection criteria, were selected for this study. Subject were randomly allocated into 14 high frequency repetitive transcarnial magnetic stimulation+motor learning group(experimental group), 16 sham repetitive transcranial magnetic stimulation+motor learning group(control group).

Intervention : 12 sessions, 3d/wk, 4week Studies : upper limb functional assessment(FMA-U/L, BBT), hand grip force assessment(disital hand dynamometer), activities daily of living assessment(K-MBI) Evaluation : 1)pre test 2)post test

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Hemiplegia	Device: HF-rTMS Behavioral: ML Device: Sham-rTMS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effects of High Frequency Repetitive Transcranial Magnetic Stimulation Combined Motor Learning on Motor Function and Grip Force for Upper Limbs and Activities of Daily Living in Sub-acute Stroke Patients

Actual Study Start Date :

May 13, 2016

Actual Primary Completion Date :

Jul 29, 2016

Actual Study Completion Date :

Aug 5, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HF-rTMS and ML High frequency Repetitive Transcranial Magnetic Stimulation and Motor Learning(Experimental group)	Device: HF-rTMS HF-rTMS stimulated a 70-mm, 8-shaped coil stimulator (The Magstim Company, UK, 2012) on the damaged cerebral cortex. Prior to the application of HF-rTMS, the motor point was identified that stimulates maximum thresholds on the primary motor cortex, causing flexion of the opposite index finger. If the cerebral hemisphere does not show a kinetic response even at the maximum stimulus, the motor point of the opposite hemisphere was found to be symmetrically changed. The intensity of the stimulus was 80% of the resting motor threshold, which means the motor eveked potential above which the first dorsal interosseous muscle can produce 50 μV more than five times out of 10 stimuli. The subject sat on a chair made to hold the head. The stimulation was stimulated at high frequency (10 Hz) for 2 seconds, and the rest was performed for 58 seconds for a total of 200 times for 10 minutes. Other Names: High Frequency repetitive Transcranial Magnetic Stimulation(HF-rTMS) Behavioral: ML Motor learning was conducted for two minutes each in five sessions, and the first is the external rotation training to maximum range of the shoulder joint in sitting position. The second method is to stack cups by transferring them from the non-affected side to the affected side by transferring 25 plastic cups of five colors in sitting position with both hands inserted. Third, by pushing and pulling the ball forward and backward with the hands folded, the subject puts a 55 cm healing ball on the table in a sitting position, and pushes and pulls it forward with the upper limb. The fourth method is to insert and remove pegs from the peg board, and the target uses the affected side hand in sitting position. The fifth method is to tear a newspaper, in which the subject overlaps a newspaper on the table in a sitting position, holds it with the non-affected hand, and tears it with the hands of the damage. A total of 10 minutes of motor learning. Other Names: Motor Learning(ML)
Sham Comparator: Sham-rTMS and ML Sham Repetitive Transcranial Magnetic Stimulation and Motor Learning	Behavioral: ML Motor learning was conducted for two minutes each in five sessions, and the first is the external rotation training to maximum range of the shoulder joint in sitting position. The second method is to stack cups by transferring them from the non-affected side to the affected side by transferring 25 plastic cups of five colors in sitting position with both hands inserted. Third, by pushing and pulling the ball forward and backward with the hands folded, the subject puts a 55 cm healing ball on the table in a sitting position, and pushes and pulls it forward with the upper limb. The fourth method is to insert and remove pegs from the peg board, and the target uses the affected side hand in sitting position. The fifth method is to tear a newspaper, in which the subject overlaps a newspaper on the table in a sitting position, holds it with the non-affected hand, and tears it with the hands of the damage. A total of 10 minutes of motor learning. Other Names: Motor Learning(ML) Device: Sham-rTMS Sham rTMS gives a small intensity of 2% of the resting motor threshold that cannot cause excitement in the motor cortex, and is set to listen to the same frequency of noise as HF-rTMS, and motor learning is applied equally. A total of 20 minutes were applied three times a week for four weeks by applying 10 minutes of Sham rTMS and 10 minutes of motor learning. Other Names: Sham repetitive Transcranial Magnetic Stimulation(Sham-rTMS)

Arm

Intervention/Treatment

Experimental: HF-rTMS and ML

High frequency Repetitive Transcranial Magnetic Stimulation and Motor Learning(Experimental group)

Device: HF-rTMS

HF-rTMS stimulated a 70-mm, 8-shaped coil stimulator (The Magstim Company, UK, 2012) on the damaged cerebral cortex. Prior to the application of HF-rTMS, the motor point was identified that stimulates maximum thresholds on the primary motor cortex, causing flexion of the opposite index finger. If the cerebral hemisphere does not show a kinetic response even at the maximum stimulus, the motor point of the opposite hemisphere was found to be symmetrically changed. The intensity of the stimulus was 80% of the resting motor threshold, which means the motor eveked potential above which the first dorsal interosseous muscle can produce 50 μV more than five times out of 10 stimuli. The subject sat on a chair made to hold the head. The stimulation was stimulated at high frequency (10 Hz) for 2 seconds, and the rest was performed for 58 seconds for a total of 200 times for 10 minutes.

Other Names:

High Frequency repetitive Transcranial Magnetic Stimulation(HF-rTMS)

Behavioral: ML

Motor learning was conducted for two minutes each in five sessions, and the first is the external rotation training to maximum range of the shoulder joint in sitting position. The second method is to stack cups by transferring them from the non-affected side to the affected side by transferring 25 plastic cups of five colors in sitting position with both hands inserted. Third, by pushing and pulling the ball forward and backward with the hands folded, the subject puts a 55 cm healing ball on the table in a sitting position, and pushes and pulls it forward with the upper limb. The fourth method is to insert and remove pegs from the peg board, and the target uses the affected side hand in sitting position. The fifth method is to tear a newspaper, in which the subject overlaps a newspaper on the table in a sitting position, holds it with the non-affected hand, and tears it with the hands of the damage. A total of 10 minutes of motor learning.

Other Names:

Motor Learning(ML)

Sham Comparator: Sham-rTMS and ML

Sham Repetitive Transcranial Magnetic Stimulation and Motor Learning

Behavioral: ML

Other Names:

Motor Learning(ML)

Device: Sham-rTMS

Sham rTMS gives a small intensity of 2% of the resting motor threshold that cannot cause excitement in the motor cortex, and is set to listen to the same frequency of noise as HF-rTMS, and motor learning is applied equally. A total of 20 minutes were applied three times a week for four weeks by applying 10 minutes of Sham rTMS and 10 minutes of motor learning.

Other Names:

Sham repetitive Transcranial Magnetic Stimulation(Sham-rTMS)

Outcome Measures

Primary Outcome Measures

Fugl Meyer Assessment - Upper Limb(FMA-U/L) [Change from baseline at the end of four weeks intervention]
The FMA-U/L score is a tool for evaluating the body's structure, function, and activity level as an evaluation tool for evaluating motor function according to Brunnstrom's recovery phase of Step 6. The minimum value is 0 point and the maximum value is 66 points, and the higher the score, the better the outcome.

Secondary Outcome Measures

Box and Block Test(BBT) [Change from baseline at the end of four weeks intervention]
The Box and Block Test(BBT) is device to assess upper limb dexterity in stroke patients
Digital hand dynamometer [Change from baseline at the end of four weeks intervention]
The digital hand dynamometer is device to assess hand grip force in stroke patients
Korean version of the Modified Barthel Index(K-MBI) [Change from baseline at the end of four weeks intervention]
The Korean version of the Modified Barthel Index (K-MBI) is a functional change sensitive evaluation tool. The minimum value is 0 point and the maximum value is 100 points, and the higher the score, the better the outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hemiplegia from stroke
Factors within six months of onset
Found to have subcortex damage through diagnoses of magnetic resonance imaging(MRI)
Had motor defects on the damaged upper extremities
Korean version Mini mental state examination(MMSE-K) score greater than 24 points

Exclusion Criteria:

Permanent damage such as heart vein
Upper limb fractures
Neurological damage such as Parkinson's, multiple sclerosis
Other reasons limiting upper limb movement
Epilepsy or family history of epilepsy
wearing a metal tube in skull or pacemaker
The lesion at occipital lobe

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chungnam National University Sejong Hospital

Investigators

Principal Investigator: JungWoo Shim, master, Chungnam National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JungWoo Shim, Principal Investigator, Chungnam National University Sejong Hospital

ClinicalTrials.gov Identifier:

NCT05176613

Other Study ID Numbers:

2016071HR

First Posted:

Jan 4, 2022

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Hemiplegia

Study Results

No Results Posted as of Jan 21, 2022