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NCT Number: NCT06270238

Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients

The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

rTMS treatment for patients with stroke is traditionally based on interhemispheric interactions. The widely-used traditional rTMS treatment protocol involves inhibitory low-frequency or continuous theta burst stimulation (cTBS) applied over the contralesional hemisphere and excitatory high-frequency stimulation over the ipsilesional hemisphere. However, concerns have arisen regarding the effect of rTMS on motor recovery in stroke patients. Although still subject to debate, a possible reason for the diverse results of rTMS applied to stroke patients is the uniform application protocol to individuals with varying pathologies and functional reserves, aimed at enhancing recovery.

Therefore, this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each hemiplegic stroke patient.

Based on screening evaluations (TMS-induced motor evoked potential (MEP), diffusion tensor imaging (DTI), MRI), investigators hypothesized that patients could be categorized into three groups: 1) preserved ipsilateral corticospinal tract, 2) preserved ipsilateral alternative corticospinal tract, and 3) no ipsilateral corticospinal tract preserved. For each group, investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional inhibitory rTMS applied to the contralesional primary motor cortex.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized,
  • FMA score of the upper extremity ≤42,
  • adequate language and cognitive function to perform at least a 1-step obey-command,
  • pre-stroke functional level of modified Rankin Scale (mRS) ≤1,
  • aged ≥19 years old,
  • patients willing to sign the informed consent.

Exclusion criteria

  • those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,
  • those with progressive of hemodynamically unstable medical conditions,
  • those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease,
  • those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
  • those having contraindications to conduct an MRI study,
  • those who are pregnant or lactating ,
  • patients who have refused to participate in this study.

Treatment and study plan

High-Frequency1

Device

rTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses.

rTMS target: ipsilateral primary motor cortex.

Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.

Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

cTBS1

Device

rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses.

rTMS target: contralateral primary motor cortex.

Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.

Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

High-Frequency2

Device

rTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses.

rTMS target: ipsilateral premotor cortex.

Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.

Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

cTBS2

Device

rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses.

rTMS target: contralateral primary motor cortex.

Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.

Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

High-Frequency3

Device

rTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses.

rTMS target: contralateral primary motor cortex.

Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.

Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

cTBS3

Device

rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses.

rTMS target: contralateral primary motor cortex.

Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.

Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.

Primary outcomes

  1. Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)

    Time frame: From baseline T0 to Post-intervention T2 (2 weeks)

    Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better

Secondary outcomes

  1. Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)

    Time frame: From baseline T0 to During-intervention T1 (1 week)

    Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better

  2. Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)

    Time frame: From baseline T0 to Follow-up T3 (2 months)

    Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better

  3. Differences of Fugl-Meyer Assessment score (FMA)

    Time frame: From baseline T0 to During-intervention T1 (1 week)

    Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better

  4. Differences of Fugl-Meyer Assessment score (FMA)

    Time frame: From baseline T0 to Post-intervention T2 (2 weeks)

    Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better

  5. Differences of Fugl-Meyer Assessment score (FMA)

    Time frame: From baseline T0 to Follow-up T3 (2 months)

    Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better

  6. Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)

    Time frame: From baseline T0 to During-intervention T1 (1 week)

    Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better

  7. Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)

    Time frame: From baseline T0 to Post-intervention T2 (2 weeks)

    Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better

  8. Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)

    Time frame: From baseline T0 to Follow-up T3 (2 months)

    Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better

  9. Differences of Box and block test

    Time frame: From baseline T0 to During-intervention T1 (1 week)

    Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.

  10. Differences of Box and block test

    Time frame: From baseline T0 to Post-intervention T2 (2 weeks)

    Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.

  11. Differences of Box and block test

    Time frame: From baseline T0 to Follow-up T3 (2 months)

    Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.

  12. Differences of Functional Ambulation Category (FAC)

    Time frame: From baseline T0 to During-intervention T1 (1 week)

    Measurement for gait function. Minimum: 0, Maximum: 5 Higher score means a better.

  13. Differences of Functional Ambulation Category (FAC)

    Time frame: From baseline T0 to Post-intervention T2 (2 weeks)

    Measurement for gait function. Minimum: 0, Maximum: 5 Higher score means a better.

  14. Differences of Functional Ambulation Category (FAC)

    Time frame: From baseline T0 to Follow-up T3 (2 months)

    Measurement for gait function. Minimum: 0, Maximum: 5. Higher score means a better.

  15. Differences of Action Research Arm Test (ARAT)

    Time frame: From baseline T0 to During-intervention T1 (1 week)

    Measurement to assess upper extremity performance (coordination, dexterity and functioning).

    Minimum: 0, Maximum: 57. Higher score means a better.

  16. Differences of Action Research Arm Test (ARAT)

    Time frame: From baseline T0 to Post-intervention T2 (2 weeks)

    Measurement to assess upper extremity performance (coordination, dexterity and functioning).

    Minimum: 0, Maximum: 57. Higher score means a better.

  17. Differences of Action Research Arm Test (ARAT)

    Time frame: From baseline T0 to Follow-up T3 (2 months)

    Measurement to assess upper extremity performance (coordination, dexterity and functioning).

    Minimum: 0, Maximum: 57. Higher score means a better.

  18. Differences of Jebsen-Taylor hand function test

    Time frame: From baseline T0 to During-intervention T1 (1 week)

    Measurement of fine and gross motor hand function using simulated activities of daily living.

    Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.

  19. Differences of Jebsen-Taylor hand function test

    Time frame: From baseline T0 to Post-intervention T2 (2 weeks)

    Measurement of fine and gross motor hand function using simulated activities of daily living.

    Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.

  20. Differences of Jebsen-Taylor hand function test

    Time frame: From baseline T0 to Follow-up T3 (2 months)

    Measurement of fine and gross motor hand function using simulated activities of daily living.

    Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.

  21. Differences of Hand grip strength test

    Time frame: From baseline T0 to During-intervention T1 (1 week)

    Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.

  22. Differences of Hand grip strength test

    Time frame: From baseline T0 to Post-intervention T2 (2 weeks)

    Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.

  23. Differences of Hand grip strength test

    Time frame: From baseline T0 to Follow-up T3 (2 months)

    Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.

Study contacts

Contact information is provided by the study sponsor or research team.

Ho Seok Lee, PhD

CONTACT

[email protected]

82-2-3410-2810

Won Hyuk Chang, PhD

CONTACT

[email protected]

82-2-3410-6068

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Bucheon St. Mary's Hospital
  • Kumoh National Institute of Technology
  • Ministry of Food and Drug Safety, Korea
  • NEUROPHET
  • National Research Foundation of Korea
  • Saint Vincent's Hospital, Korea
  • Seoul National University Hospital
  • Severance Hospital

Registry information

Official study title

Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients: A Multi Center, Randomized, Single Blind, Parallel Group Prospective Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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