Effect of opposing needling on motor cortex excitability in healthy participants and in patients with post-stroke hemiplegia: Study protocol for a single-blind, randomised controlled trial

Abstract

Background: Opposing needling has obvious curative effect in the treatment of poststroke hemiplegia, however, the mechanism of the opposing needling in the treatment of poststroke hemiplegia is still not clear. The purpose of this study is to investigate the effect of opposing needling on the excitability of primary motor cortex(M1) of healthy subjects and patients with poststroke hemiplegia, which may provide insight into the mechanisms of opposing needling in treating poststroke hemiplegia.Methods: This will be a single-blind, randomised, sham-controlled trial in which 80 healthy participants and 40 patients with post-stroke hemiplegia will be recruited. Healthy participants will be randomised 1:1:1:1 to the 2-Hz, 50-Hz, 100-Hz, and sham electroacupuncture groups. Patients with post-stroke hemiplegia will be randomised 1:1 to the opposing needling or conventional treatment groups. The M1 will be located in both groups by using neuroimaging-based navigation. The stimulator coil of transcranial magnetic stimulation (TMS) will be moved over the left and right M1 in order to identify the TMS hotspot, followed by recording of motor-evoked potentials (MEPs) and resting motor thresholds (RMTs) of the thenar muscles induced by TMS before and after electroacupuncture or sham electroacupuncture. The primary outcome measure will be the percent change in the RMT of the thenar muscles at baseline and after the intervention. The secondary outcome measures will be the amplitude (μV) and latency (ms) of the MEP of the thenar muscles at baseline and after the intervention.Discussion: The aim of this trial is to explore the effect of opposing needling on the excitability of M1of healthy subjects and patients with poststroke hemiplegia.Trial registration: Chinese Clinical Trial Registry, ChiCTR1900028138, Registered on 13 December 2019.