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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05663424
• Other study ID #: 111-080-F
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Sheng-Hao Cheng, MD
• Phone: 0972652433
• Email: shcheng1106[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• rTMS-PTi
10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus immediate rehabilitation programs
• rTMS-PTd
10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus delayed rehabilitation programs (>2hr)
• rTMSs-PT
10 daily sessions of sham rTMS (to vertex) plus rehabilitation programs

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsin-Chu Branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (FMA)	Fugl-Meyer Assessment (FMA) of upper limb	12 weeks
Secondary	Medical Research Council (MRC) scale	Medical Research Council (MRC) scale	12 weeks
Secondary	Grip strength	Grip strength (Kg)	12 weeks
Secondary	Barthel Index	Barthel Index	12 weeks
Secondary	Modified Rankin Scale	Modified Rankin Scale	12 weeks
Secondary	maximal motor evoked potential amplitude	maximal motor evoked potential amplitude of lesion site (mV)	12 weeks
Secondary	motor evoked potential latency	motor evoked potential latency of lesion site (ms)	12 weeks
Secondary	resting motor threshold	bilateral resting motor threshold (mV)	12 weeks