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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Oct 2023
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2027
ExpectedOctober 18, 2024
October 1, 2024
1.6 years
June 13, 2023
October 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Assessment
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
12 weeks post intervention
Secondary Outcomes (7)
Medical Research Council (MRC) Scale for Muscle Strength
1 week, 4 weeks, 12 weeks post intervention
National Institutes of Health Stroke Scale
1 week, 4 weeks, 12 weeks post intervention
Barthel Index
1 week, 4 weeks, 12 weeks post intervention
Modified Rankin Scale
1 week, 4 weeks, 12 weeks post intervention
MEP
1 week, 4 weeks, 12 weeks post intervention
- +2 more secondary outcomes
Study Arms (2)
individualized rTMS
EXPERIMENTALPatients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy
Traditional rTMS
ACTIVE COMPARATORControl group is given traditional rTMS
Interventions
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.
Eligibility Criteria
You may qualify if:
- Unilateral ischemic or hemorrhagic stroke
- Stroke within 3 months
- Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
- Patient could sit over 15 minutes
- Age over 20
You may not qualify if:
- Previous stroke, traumatic brain injury, brain tumor
- With central nervous system disease (spinal cord injury, Parkinson's disease)
- Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
- Patients unable to cooperate the treatment
- Pregnancy
- Depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei County, Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meng Ting Lin, M.D.
The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2023
First Posted
June 22, 2023
Study Start
October 13, 2023
Primary Completion
May 20, 2025
Study Completion (Estimated)
May 20, 2027
Last Updated
October 18, 2024
Record last verified: 2024-10