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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05914038
Other study ID # 202301225DIND
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date May 20, 2027

Study information

Verified date May 2023
Source National Taiwan University Hospital
Contact Meng Ting Lin, M.D.
Phone +886-2312-3456
Email b96401093@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 20, 2027
Est. primary completion date May 20, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Stroke
  • Transcranial Magnetic Stimulation

Intervention

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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei county Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl-Meyer Assessment Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. 12 weeks post intervention
Secondary Medical Research Council (MRC) Scale for Muscle Strength Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). 1 week, 4 weeks, 12 weeks post intervention
Secondary National Institutes of Health Stroke Scale 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. 1 week, 4 weeks, 12 weeks post intervention
Secondary Barthel Index Barthel Index, score 100-0. Higher scores indicate a better outcome. 1 week, 4 weeks, 12 weeks post intervention
Secondary Modified Rankin Scale Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome. 1 week, 4 weeks, 12 weeks post intervention
Secondary MEP motor evoked potential 1 week, 4 weeks, 12 weeks post intervention
Secondary Fugl-Meyer Assessment Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. 1 week, 4 weeks post intervention
Secondary functional NIRS Functional Near Infrared Spectroscopy to detect the cortical excitability 1 week, 4 weeks, 12 weeks post intervention
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