Clinical trial NCT05663424: Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients
Official title: Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: rTMS
stroke
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 12 weeks
Secondary outcomes:
measure: Medical Research Council (MRC) scale
timeFrame: 12 weeks
measure: Grip strength
timeFrame: 12 weeks
measure: Barthel Index
timeFrame: 12 weeks
measure: Modified Rankin Scale
timeFrame: 12 weeks
measure: maximal motor evoked potential amplitude
timeFrame: 12 weeks
measure: motor evoked potential latency
timeFrame: 12 weeks
measure: resting motor threshold
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
Study officials:
affiliation: The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch
name: Sheng-Hao Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: