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NCT Number: NCT05613686

Theta Burst Stimulation for Motor Recovery

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

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Key information

Conditions

Transcranial Magnetic Stimulation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Meng Ting Lin, M.D.

CONTACT

[email protected]

+886-2312-3456

About this study

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.

High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.

This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Unilateral ischemic or hemorrhagic stroke
  • 2.Stroke within 3 months
  • 3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
  • 4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
  • 5.Patient could sit over 15 minutes
  • 6.Age over 20

Exclusion criteria

  • 1.Previous stroke, traumatic brain injury, brain tumor
  • 2.With central nervous system disease (spinal cord injury, Parkinson's disease)
  • 3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
  • 4.Patients unable to cooperate the treatment
  • 5.Pregnancy
  • 6.Depression

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect.

Primary outcomes

  1. Fugl-Meyer Assessment

    Time frame: 12 weeks post intervention

    Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

Secondary outcomes

  1. Medical Research Council (MRC) Scale for Muscle Strength

    Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention

    Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).

  2. National Institutes of Health Stroke Scale

    Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention

    National Institutes of Health Stroke Scale, The maximum possible score is 42, with the minimum score being a 0. Higher scores indicate a worse outcome.

  3. Barthel Index

    Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention

    Barthel Index, score 100-0. Higher scores indicate a better outcome.

  4. Modified Rankin Scale

    Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention

    Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome.

  5. MEP

    Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention

    motor evoked potential

  6. Fugl-Meyer Assessment

    Time frame: 1 week post intervention

    Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

  7. Fugl-Meyer Assessment

    Time frame: 4 weeks post intervention

    Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

  8. Fugl-Meyer Assessment

    Time frame: 24 weeks post intervention

    Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

Study contacts

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

Meng Ting Lin, M.D.

CONTACT

[email protected]

+886-2312-3456 ext. 67048

Ming Yen Hsiao, M.D., PhD

CONTACT

[email protected]

+886-2312-3456 ext. 67316

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Comparative Efficacy of Different Doses of Theta Burst Stimulation for Motor Recovery in Stroke Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Aug 19, 2024

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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