Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
Phase: NA
Conditions: Stroke, Motor Disorder
Sponsor: Samsung Medical Center

 
 
Effects on Brain Network by Simultaneous Dual-mode 
Stimulation in Subacute Stroke Patients 
 
NCT03279640 
 
 
 
 
 
 
 
 
 
September 10, 2017 
 
 

Protocol 
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation 
(tDCS) has been used for the modulation of stroke patients’ motor function by altering the 
cortical excitability. Recently, more challenging approaches, such as stimulation of two or more 
sites or use of dual modality have been studied in stroke patients. In this study, simultaneous 
stimulation using both rTMS and tDCS (dual-mode stimulation) over bilateral primary motor 
cortices (M1s) was investigated to compare its modulatory effects with single rTMS 
stimulation in subacute stroke patients. 
Twenty-four subacute stroke patients were recruited for this study. The inclusion criteria were 
patients who had suffered their first-ever stroke within 4 weeks of entering the study and had 
a total Fugl-Meyer Assessment (FMA) score under 84. The exclusion criteria were patients 
who had a major active underlying neurological disease or psychiatric disease, a history of 
seizure, or metallic implants in their brain. Twelve participants were assigned to the dual-mode 
stimulation group (rTMS on ipsilesional M1 and tDCS on contralesional M1) and the other 
twelve participants were assigned to the single stimulation group (only rTMS on ipsilesional 
M1). 
A randomized, open-label, parallel study design was adopted in this study. All participants 
underwent ten daily sessions of stimulation for 2 weeks under one of two different conditions. 
In the dual-mode stimulation group, 10 Hz of rTMS was applied over the ipsilesional M1 for 
20 minutes with simultaneous application of cathodal tDCS on the contralesional M1. In the 
single stimulation group, only 10 Hz of rTMS over the ipsilesional M1 was applied. 
Investigators assessed each participant’s total FMA score and acquired their resting-state fMRI 
data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-
stimulation). 

Statistical analysis 
The Shapiro-Wilk test was performed to test data for normal distribution. The null hypothesis 
was rejected in all cases. Repeated-measures ANOVA was performed to determine whether 
there were any significant differences between group and time (pre-stimulation and post-
stimulation) effects in the resting-state network measures. Paired t-tests were used to evaluate 
within-group differences over time. Post-hoc analysis with the Bonferroni correction was also 
performed. The repeated-measures ANOVA and paired t-tests were performed using ranova 
and ttest functions, respectively, in the statistics toolbox of Matlab R2014b. The threshold for 
statistical significance was set at p<0.05 for this study.