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Clinical Trial Summary

There has been A-level evidence for the effectiveness of inhibitory rTMS of the contralesional M1 hand region in stroke patients in the acute stage. However, it has been reported to be ineffective in the chronic stage. In addition, it has been reported that the patient group benefiting from rTMS is mostly those with moderate to mild motor impairment. In contrast, a recent randomized controlled study has reported that ipsilesional excitatory rTMS or contra-lesional inhibitory rTMS may also have positive effects in stroke patients with severe upper limb motor impairment. The aim of this study is to investigate the effect of inhibitory repetitive transcranial magnetic stimulation applied to the contralesional primary motor cortex, by using the rTMS parameters specified in the current recommendation guide, on motor function, activities of daily living, and quality of life in subacute stroke patients with severe upper limb motor impairment.


Clinical Trial Description

The level of stroke-related upper limb motor impairment varies widely among individuals, from mild to severe. Because of this heterogeneity, rehabilitation interventions are tailored individually. In recent years, many studies have been published on the effectiveness of add-on non-invasive neuromodulation methods such as transcranial magnetic stimulation (TMS) or transcranial direct current stimulation in the treatment of stroke-related upper limb motor impairment. There has been A-level evidence for the effectiveness of inhibitory rTMS of the contralesional M1 hand region in stroke patients in the acute stage. However, it has been reported to be ineffective in the chronic stage. In addition, it has been reported that the patient group benefiting from rTMS is mostly those with moderate to mild motor impairment. It has been reported that contra-lesional hemisphere inactivation impairs paretic upper extremity performance in severely infarcted animals. In humans, contra-lesional hemisphere inactivation has been reported to slow down the reaction time. In contrast, a recent randomized controlled study has reported that ipsilesional excitatory rTMS or contralesional inhibitory rTMS may have positive effects in stroke patients with severe upper limb motor impairment. However, the literature on rTMS in post-stroke rehabilitation is highly heterogeneous in terms of frequency, session duration, location, patient characteristics, and outcome scales, and this ambiguity makes it difficult to adapt rTMS to the clinical practice. In this regard, future studies are needed to determine whether rTMS provides an additional benefit to traditional/task-specific rehabilitation approaches in stroke patients with severe upper limb paresis. The aim of this study is to investigate the effect of inhibitory repetitive transcranial magnetic stimulation applied to the contralesional primary motor cortex, by using the rTMS parameters specified in the current recommendation guide, on motor function, activities of daily living, and quality of life in subacute stroke patients with severe upper limb motor impairment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05505201
Study type Interventional
Source Izmir Katip Celebi University
Contact Ilker Sengül, M.D.
Phone 0905337333698
Email ilkrsngl@gmail.com
Status Recruiting
Phase N/A
Start date November 11, 2022
Completion date September 30, 2025

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