Theta Burst Stimulation for Motor Recovery

Not Applicable

Recruiting

• Conditions: Transcranial Magnetic Stimulation
• Interventions: Device: repetitive transcranial magnetic stimulation

• Registration Number: NCT05613686
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-10-29
• Study First Submitted: 2022-10-30
• Study First Submitted QC: 2022-11-06
• Study First Posted: 2022-11-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-10-29
• Study Completion: 2024-10-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
contralateral 1Hz+ipsilateral iTBS 1	repetitive transcranial magnetic stimulation	Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1
contralateral 1Hz+ipsilateral iTBS 2	repetitive transcranial magnetic stimulation	Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2
contralateral 1Hz	repetitive transcranial magnetic stimulation	Patients received contralateral 1 Hz and ipsilateral sham iTBS

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment	12 weeks post intervention	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

Secondary Outcome Measures

Name	Time	Method
Barthel Index	1 week, 4 weeks, 12 weeks and 24 weeks post intervention	Barthel Index, score 100-0. Higher scores indicate a better outcome.
Medical Research Council (MRC) Scale for Muscle Strength	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).
Modified Rankin Scale	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.
National Institutes of Health Stroke Scale	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.
MEP	1 week, 4 weeks, 12 weeks and 24 weeks post intervention	motor evoked potential
Fugl-Meyer Assessment	24 weeks post intervention	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan