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Individualized rTMS for Motor Recovery in Stroke Patients

Efficacy of Individualized Repetitive Transcranial Magnetic Stimulation Based on Cortical Laterality for Motor Recovery in Stroke Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05914038
Enrollment
40
Registered
2023-06-22
Start date
2023-10-13
Completion date
2027-05-20
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Transcranial Magnetic Stimulation

Brief summary

This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index 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. However, the current rTMS studies for stroke patients utilized the same therapeutic protocol and there is no individualized rTMS protocol based on the value of lateralization index. This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.

Interventions

DEVICERepetitive transcranial magnetic stimulation

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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment12 weeks post interventionFugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

Secondary

MeasureTime frameDescription
Medical Research Council (MRC) Scale for Muscle Strength1 week, 4 weeks, 12 weeks post interventionMedical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
National Institutes of Health Stroke Scale1 week, 4 weeks, 12 weeks post interventionNational Institutes of Health Stroke Scale, The maximum possible score is 42, with the minimum score being a 0. Higher scores indicate a worse outcome.
Barthel Index1 week, 4 weeks, 12 weeks post interventionBarthel Index, score 100-0. Higher scores indicate a better outcome.
Modified Rankin Scale1 week, 4 weeks, 12 weeks post interventionModified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome.
MEP1 week, 4 weeks, 12 weeks post interventionmotor evoked potential
Fugl-Meyer Assessment1 week, 4 weeks post interventionFugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
functional NIRS1 week, 4 weeks, 12 weeks post interventionFunctional Near Infrared Spectroscopy to detect the cortical excitability

Countries

Taiwan

Contacts

Primary ContactMeng Ting Lin, M.D.
b96401093@ntu.edu.tw+886-2312-3456
Backup ContactYan Ci Liu, PhD
yanciliu@ntu.edu.tw+886233668135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026