Individualized rTMS for Motor Recovery in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914038
• Other study ID #: 202301225DIND
• Status: Recruiting
• Phase: N/A
• 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
• 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

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