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Individualized rTMS for Motor Recovery in Stroke Patients

Primary Purpose

Stroke, Transcranial Magnetic Stimulation

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Repetitive transcranial magnetic stimulation

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

individualized rTMS

Traditional rTMS

Arm Description

Patients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy

Control group is given traditional rTMS

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment

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

Secondary Outcome Measures

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).

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.

Barthel Index

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

Modified Rankin Scale

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

MEP

motor evoked potential

Fugl-Meyer Assessment

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

functional NIRS

Functional Near Infrared Spectroscopy to detect the cortical excitability

Full Information

NCT ID

NCT05914038

First Posted

June 13, 2023

Last Updated

October 22, 2023

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05914038

Brief Title

Individualized rTMS for Motor Recovery in Stroke Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2023 (Anticipated)

Primary Completion Date

May 20, 2025 (Anticipated)

Study Completion Date

May 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

individualized rTMS

Arm Type

Experimental

Arm Description

Patients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy

Arm Title

Traditional rTMS

Arm Type

Active Comparator

Arm Description

Control group is given traditional rTMS

Intervention Type

Device

Intervention Name(s)

Repetitive transcranial magnetic stimulation

Intervention 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.

Primary Outcome Measure Information:

Title

Fugl-Meyer Assessment

Description

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

Time Frame

12 weeks post intervention

Secondary Outcome Measure Information:

Title

Medical Research Council (MRC) Scale for Muscle Strength

Description

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

Time Frame

1 week, 4 weeks, 12 weeks post intervention

Title

National Institutes of Health Stroke Scale

Description

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.

Time Frame

1 week, 4 weeks, 12 weeks post intervention

Title

Barthel Index

Description

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

Time Frame

1 week, 4 weeks, 12 weeks post intervention

Title

Modified Rankin Scale

Description

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

Time Frame

1 week, 4 weeks, 12 weeks post intervention

Title

MEP

Description

motor evoked potential

Time Frame

1 week, 4 weeks, 12 weeks post intervention

Title

Fugl-Meyer Assessment

Description

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

Time Frame

1 week, 4 weeks post intervention

Title

functional NIRS

Description

Functional Near Infrared Spectroscopy to detect the cortical excitability

Time Frame

1 week, 4 weeks, 12 weeks post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meng Ting Lin, M.D.

Phone

+886-2312-3456

Ext

67048

b96401093@ntu.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Ci Liu, PhD

Phone

+886233668135

yanciliu@ntu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meng Ting Lin, M.D.

Organizational Affiliation

The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei county

State/Province

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meng Ting Lin, M.D.

Phone

0223123456

Ext

67651

b96401093@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Individualized rTMS for Motor Recovery in Stroke Patients

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