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CompletedNCT05176613Updated Jan 21, 2022

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

An interventional study of HF-rTMS and ML in Stroke, Acute and Hemiplegia, sponsored by Chungnam National University Sejong Hospital. Completed. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by Chungnam National University Sejong Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 years 6 months after the study started (first participant enrolled May 2016, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study 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

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Conditions studied

  • Stroke, Acute
  • Hemiplegia
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Chungnam National University Sejong Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    HF-rTMS and ML

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

    Device: HF-rTMS · Behavioral: ML

  • Sham comparator
    Sham-rTMS and ML

    Sham Repetitive Transcranial Magnetic Stimulation and Motor Learning

    Behavioral: ML · Device: Sham-rTMS

Interventions

  • DeviceHF-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.

    Also known as: High Frequency repetitive Transcranial Magnetic Stimulation(HF-rTMS)

  • BehavioralML

    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.

    Also known as: Motor Learning(ML)

  • DeviceSham-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.

    Also known as: Sham repetitive Transcranial Magnetic Stimulation(Sham-rTMS)

06

What researchers measure

Primary outcomes

  1. Fugl Meyer Assessment - Upper Limb(FMA-U/L)

    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.

    Time frame: Change from baseline at the end of four weeks intervention

Secondary outcomes

  1. Box and Block Test(BBT)

    The Box and Block Test(BBT) is device to assess upper limb dexterity in stroke patients

    Time frame: Change from baseline at the end of four weeks intervention

  2. Digital hand dynamometer

    The digital hand dynamometer is device to assess hand grip force in stroke patients

    Time frame: Change from baseline at the end of four weeks intervention

  3. Korean version of the Modified Barthel Index(K-MBI)

    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.

    Time frame: Change from baseline at the end of four weeks intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05176613
Lead sponsor
Chungnam National University Sejong Hospital
Responsible party
JungWoo Shim (Principal Investigator, Chungnam National University Sejong Hospital) — Principal investigator
First posted
Jan 4, 2022
Start date
May 13, 2016
Primary completion
Jul 29, 2016
Completion
Aug 5, 2016
Last update
Jan 21, 2022

Study contacts

JungWoo Shim, master
principal investigator · Chungnam National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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