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

NCT ID: NCT05663424

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Keywords

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rTMS stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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immediate rehabilitation group

rTMS plus immediate rehabilitation programs

Group Type EXPERIMENTAL

rTMS-PTi

Intervention Type OTHER

10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus immediate rehabilitation programs

delayed rehabilitation group

rTMS plus delayed rehabilitation programs

Group Type EXPERIMENTAL

rTMS-PTd

Intervention Type OTHER

10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus delayed rehabilitation programs (\>2hr)

sham rTMS group

sham rTMS + rehabilitation programs

Group Type SHAM_COMPARATOR

rTMSs-PT

Intervention Type OTHER

10 daily sessions of sham rTMS (to vertex) plus rehabilitation programs

Interventions

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rTMS-PTi

10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus immediate rehabilitation programs

Intervention Type OTHER

rTMS-PTd

10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus delayed rehabilitation programs (\>2hr)

Intervention Type OTHER

rTMSs-PT

10 daily sessions of sham rTMS (to vertex) plus rehabilitation programs

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheng-Hao Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch

Locations

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National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Sheng-Hao Cheng, MD

Role: CONTACT

Phone: 0972652433

Email: [email protected]

Meng Ting Lin, MD

Role: CONTACT

Phone: 02-23123456

Email: [email protected]

Facility Contacts

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Sheng-Hao Cheng, MD

Role: primary

Other Identifiers

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111-080-F

Identifier Type: -

Identifier Source: org_study_id