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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Transcranial Magnetic Stimulation
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Ci Liu, PhD; Phone Number: +886233668135; Email: yanciliu@ntu.edu.tw
• Study Contact Backup: Name: Meng Ting Lin, M.D.; Phone Number: 67048 +886-2312-3456; Email: b96401093@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei
    • Taipei county, Taipei, Taiwan, 100
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Meng Ting Lin, M.D.; Phone Number: 67651 0223123456; Email: b96401093@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: individualized rTMS; Patients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy	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.
Active Comparator: Traditional rTMS; Control group is given traditional rTMS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Barthel Index	Barthel Index, score 100-0. Higher scores indicate a better outcome.	1 week, 4 weeks, 12 weeks post intervention
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
MEP	motor evoked potential	1 week, 4 weeks, 12 weeks post intervention
Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	1 week, 4 weeks post intervention
functional NIRS	Functional Near Infrared Spectroscopy to detect the cortical excitability	1 week, 4 weeks, 12 weeks post intervention

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Meng Ting Lin, M.D., The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): May 20, 2027

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 202301225DIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No