Individualized rTMS for Motor Recovery in Stroke Patients

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05914038
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 45.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Transcranial Magnetic Stimulation	Device: Repetitive transcranial magnetic stimulation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Individualized Repetitive Transcranial Magnetic Stimulation Based on Cortical Laterality for Motor Recovery in Stroke Patients
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: May 20, 2025
• Anticipated Study Completion Date: May 20, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Fugl-Meyer Assessment [12 weeks post intervention]

   Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

Secondary Outcome Measures

1. Medical Research Council (MRC) Scale for Muscle Strength [1 week, 4 weeks, 12 weeks post intervention]

   Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).

2. National Institutes of Health Stroke Scale [1 week, 4 weeks, 12 weeks post intervention]

   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.

3. Barthel Index [1 week, 4 weeks, 12 weeks post intervention]

   Barthel Index, score 100-0. Higher scores indicate a better outcome.

4. Modified Rankin Scale [1 week, 4 weeks, 12 weeks post intervention]

   Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome.

5. MEP [1 week, 4 weeks, 12 weeks post intervention]

   motor evoked potential

6. Fugl-Meyer Assessment [1 week, 4 weeks post intervention]

   Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05914038
• Other Study ID Numbers: 202301225DIND
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Jun 22, 2023