Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients

December 21, 2022 updated by: National Taiwan University Hospital Hsin-Chu Branch
Comparative Efficacy of Different Time Interval between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is one of the main causes of death and disability in Taiwan. The M1 excitability of the affected hemisphere decreases, while that of the unaffected hemisphere increases, leading to further interhemispheric inhibition. 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. Through regulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients. Previous study had been demonstrated that priming rehabilitation program with low frequent rTMS would lead to better motor recovery in the chronic stroke patients. However, the optimal time interval between the rTMS and the rehabilitation program had not been investigated. Thus, this study will utilize low frequent rTMS, targeting the intact hemisphere, to investigate the clinical effects and motor cortex excitability under different time intervals between the rTMS and the rehabilitation program.

This study is designed as a randomized controlled trial. We plan to recruit 45 subacute stroke patients with hemiplegia. The patients are randomly assigned to three groups. In the Group 1, the patients receive contralateral 1 Hz rTMS stimulation and subsequent rehabilitation program. In the Group 2, the patients receive contralateral 1 Hz rTMS, but the rehabilitation will be delayed at least two hours after the rTMS stimulation. The control group receive sham rTMS and subsequent rehabilitation program. The treatment schedule for all groups will be five times per week for a two-week course, which means a total of ten sessions. The primary outcome is upper limb Fugl-Meyer Assessment. The secondary outcomes included Medical Research Council (MRC) scale, Barthel Scale, Modified Rankin Scale (MRS), cortical excitability assessment (including bilateral maximum MEP amplitude, MEP latency, and bilateral resting motor threshold). Follow-up time points are before rTMS and at 1st, 4th, 12th weeks after the end of the treatments.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Hsinchu, Taiwan
        • National Taiwan University Hospital Hsin-Chu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. >=20 years old, unilateral stroke diagnosed by CT or MRI
  2. Post-stroke 1 week to 6 months
  3. Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
  4. No history of previous stroke, seizure, dementia, parkinsonism or other neurodegenerative disease
  5. stable medical condition and vital signs

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, Pregnancy...)
  4. Patients unable to cooperate the treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate rehabilitation group
rTMS plus immediate rehabilitation programs
Other: rTMS-PTi
10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus immediate rehabilitation programs
Experimental: delayed rehabilitation group
rTMS plus delayed rehabilitation programs
Other: rTMS-PTd
10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus delayed rehabilitation programs (>2hr)
Sham Comparator: sham rTMS group
sham rTMS + rehabilitation programs
Other: rTMSs-PT
10 daily sessions of sham rTMS (to vertex) plus rehabilitation programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment (FMA)
Time Frame: 12 weeks
Fugl-Meyer Assessment (FMA) of upper limb
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Research Council (MRC) scale
Time Frame: 12 weeks
Medical Research Council (MRC) scale
12 weeks
Grip strength
Time Frame: 12 weeks
Grip strength (Kg)
12 weeks
Barthel Index
Time Frame: 12 weeks
Barthel Index
12 weeks
Modified Rankin Scale
Time Frame: 12 weeks
Modified Rankin Scale
12 weeks
maximal motor evoked potential amplitude
Time Frame: 12 weeks
maximal motor evoked potential amplitude of lesion site (mV)
12 weeks
motor evoked potential latency
Time Frame: 12 weeks
motor evoked potential latency of lesion site (ms)
12 weeks
resting motor threshold
Time Frame: 12 weeks
bilateral resting motor threshold (mV)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Investigators

  • Principal Investigator: Sheng-Hao Cheng, MD, The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Estimate)

December 23, 2022

Study Record Updates

Last Update Posted (Estimate)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111-080-F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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