Study protocol of a randomized controlled trial for the synergizing effects of rTMS and Tui Na on upper limb motor function and cortical activity in ischemic stroke

Abstract

Upper limb motor dysfunction after stroke is a serious threat to the living quality of patients and their families. Recovery of upper limb motor function after stroke largely relies on the activation and remodeling of neural circuits. rTMS (repetitive transcranial magnetic stimulation) has been proved to promote the reconstruction of neural synapses and neural circuits. However, there are still a large number of patients who cannot fully recover and leave behind varying degrees of dysfunction. Considering the systemic pathology after stroke, in addition to focal brain injury, stroke can also cause extensive dysfunction of peripheral organs. The rehabilitation strategy for stroke should combine the treatment of primary brain lesions with the intervention of secondary systemic damage. The aim of this trial is to verify the efficacy of rTMS synergize with Tui Na (Chinese Massage) on upper limb motor function after ischemic stroke, and to explore the mechanism of activation and remodeling of sensorimotor neural circuits with functional near-infrared spectroscopy. Ninety patients will be randomly assigned to either rTMS + Tui Na + conventional rehabilitation group (the experimental group) or rTMS + conventional rehabilitation group (the control group) in 1:1 ratio. Intervention is conducted five sessions a week, with a total of twenty sessions. The primary outcome is Fugl-Meyer Assessment, and the secondary outcomes include Muscle Strength, Modified Ashworth Assessment, Modified Barthel Index Assessment, motor evoked potentials and functional near-infrared spectroscopy. There are four time points for the evaluation, including baseline, 2 weeks and 4 weeks after the start of treatment, and 4 weeks after the end of treatment. This study is a randomized controlled trial. This study was approved by Institutional Ethics Committee of Shanghai Third Rehabilitation Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (approval No. SH3RH-2021-EC-012) on December, 16th, 2021. The protocol was registered with Chinese Clinical Trial Registry (ChiCTR2200056266), on February 3th, 2022. Patient recruitment was initiated on February 10th, 2022, and the study will be continued until December 2023.

Applications of functional near-infrared spectroscopy in non-drug therapy of traditional Chinese medicine: a review

“…The experimental group will be given Tuina and rTMS interventions based on conventional rehabilitation, while the control group received only rTMS in addition to conventional rehabilitation. Improvements in motor function and cortical hemodynamic changes after 4 weeks of treatment will be observed ( Chen Y. F. et al, 2022 ). Tang et al (2022) employed fNIRS to collect and analyze changes in the functional intensity and lateralization index of patients with lower limb motor dysfunction following stroke before and after the 4-week acupuncture and rehabilitation therapy.…”

“…the nervous system, especially regarding neuronal response regulation in the human brain ( Chen Y. F. et al, 2022 ; Wang et al, 2022 ; Xu L. P. et al, 2022 ; Yao et al, 2022 ; Chen L. et al, 2023 ). However, the human brain is the least accessible organ; therefore, in vivo studies of the human brain rely predominantly on neuroimaging.…”

The changes of neuroactivity of Tui Na (Chinese massage) at Hegu acupoint on sensorimotor cortex in stroke patients with upper limb motor dysfunction: a fNIRS study

“…fNIRS equipment (NirScan-8000A, Danyang Huichuang, China) was used to record the hemodynamic data. A total of 21 NIRS optrodes (11 light sources and 10 detectors, with wavelengths of 730 and 850nm, and a sampling rate of 19Hz) formed 32 observation channels [ 19 ]. A three-dimensional digitizer (Patriot, America) was used to collect the 3D coordinate information of the optrodes and channels to ensure the accuracy of the observed brain area and to be consistent in multiple measurements.…”

“…A three-dimensional digitizer (Patriot, America) was used to collect the 3D coordinate information of the optrodes and channels to ensure the accuracy of the observed brain area and to be consistent in multiple measurements. According to the Brodmann area (BA) and anatomical locations of the cortex, the observation channels are divided into six ROIs (regions of interest): ipsilesional premotor cortex, PMC_ipsi; contralesional premotor cortex, PMC_contra; ipsilesional primary sensorimotor cortex, SM1_ipsi; contralesional primary sensorimotor cortex, SM1_contra; supplementary motor area, SMA; Somatosensory Association Cortex, SAC[ 19 ] (Fig. 2 ).…”

Different doses of intermittent theta burst stimulation for upper limb motor dysfunction after stroke: a study protocol for a randomized controlled trial

“…The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score from baseline (T0) to end of intervention (T1) is defined as the primary outcome. The FMA-UE is a standardized scale of upper limb motor impairment ranging from 0 to a maximum of 66 points ( Fugl-Meyer et al, 1975 ; Chen Y. F. et al, 2022 ). Secondary outcomes are the Wolf Motor Function Test (WMFT), Grip Strength (GS), MAS, Modified Barthel Index (MBI), and Stroke Impact Scale (SIS).…”