NCT05663424

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

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

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-12-23
• Last updated: 2022-12-23

Locations

1 site across 1 country: Taiwan