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Recruiting NCT05914038

Individualized rTMS for Motor Recovery in Stroke Patients

No phase Interventional Stroke Transcranial Magnetic Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive transcranial magnetic stimulation.
Who it may be relevant to
Registry conditions: Stroke, Transcranial Magnetic Stimulation. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Device Repetitive 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.

Primary outcome measures

  • Fugl-Meyer Assessment [Time frame: 12 weeks post intervention]
Secondary outcome measures (7)
  • Medical Research Council (MRC) Scale for Muscle Strength [Time frame: 1 week, 4 weeks, 12 weeks post intervention]
  • National Institutes of Health Stroke Scale [Time frame: 1 week, 4 weeks, 12 weeks post intervention]
  • Barthel Index [Time frame: 1 week, 4 weeks, 12 weeks post intervention]
  • Modified Rankin Scale [Time frame: 1 week, 4 weeks, 12 weeks post intervention]
  • MEP [Time frame: 1 week, 4 weeks, 12 weeks post intervention]
  • Fugl-Meyer Assessment [Time frame: 1 week, 4 weeks post intervention]
  • functional NIRS [Time frame: 1 week, 4 weeks, 12 weeks post intervention]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei County

Identifiers

NCT: NCT05914038 · 202301225DIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗