Transcranial random noise stimulation to augment hand function in individuals with moderate-to-severe stroke: A pilot randomized clinical trial.

Background:Interventions to recover upper extremity (UE) function after moderate-to-severe stroke are limited. Transcranial random noise stimulation (tRNS) is an emerging non-invasive technique to improve neuronal plasticity and may potentially augment functional outcomes when combined with existing interventions, such as functional electrical stimulation (FES). Objective:The objective of this study was to investigate the feasibility and preliminary efficacy of combined tRNS and FES-facilitated task practice to improve UE impairment and function after moderate-to-severe stroke. Methods:Fourteen individuals with UE weakness were randomized into one of two groups: 1) tRNS with FES-facilitated task practice, or 2) sham-tRNS with FES-facilitated task practice. Both groups involved 18 intervention sessions (3 per week for 6 weeks). tRNS was delivered at 2 mA current between 100-500 Hz for the first 30 minutes of FES-facilitated task practice. We evaluated the number of sessions completed, adverse effects, participant satisfaction, and intervention fidelity between the two therapists. UE impairment (Fugl-Meyer Upper Extremity, FMUE), function (Wolf Motor Function Test, WMFT), participation (Stroke Impact Scale hand score, SIS-H), and grip strength were assessed at baseline, within 1 week and 3 months after completing the intervention. Results:All participants completed the 18 intervention sessions. Participants reported minimal adverse effects (mild tingling in head). The two trained therapists demonstrated 93% adherence and 96% competency with the intervention protocol. FMUE and SIS-H improved significantly more in the tRNS group than in the sham-tRNS group at both timepoints (p≤0.05), and the differences observed exceeded the clinically meaningful differences for these scores. The WMFT and paretic hand grip strength improved in both groups after the intervention (p≤0.05), with no significant between group differences. Conclusion:Our findings show for the first time that combining tRNS and FES-facilitated task practice is a feasible and promising approach to improve UE impairment and function after moderate-to-severe stroke.