The University of Utah is sponsoring a clinical study to investigate whether combining transcranial random noise stimulation with functional electrical stimulation-facilitated task practice improves hand function in individuals with severe paresis post-stroke. The study seeks to determine if this multimodal approach is more effective than using functional electrical stimulation alone.
The experimental randomized study is designed to compare the effects of transcranial random noise stimulation (tRNS) and functional electrical stimulation (FES) against a control group receiving sham-tRNS and FES-assisted task-specific practice. The intervention involves 18 treatment sessions conducted over 6 to 8 weeks, with sessions occurring three times per week. Researchers aim to use motor learning principles, including high repetitions and training specificity, to assist in the recovery of movement components for functional tasks.
The study is estimated to begin on 2026-11-02, with primary completion expected by 2030-12-01 and study completion estimated for 2031-02-15. Researchers expect to enroll approximately 78 participants. The study is being conducted at a location in Salt Lake City, Utah, at the University of Utah.
Eligible participants must be between 40 and 85 years old and have a diagnosis of a first-ever subcortical stroke occurring at least six months prior to participation. Candidates must demonstrate limited functional wrist and finger flexion and extension, specifically between 5 to 20 degrees of active movement, and possess cognitive skills indicated by scores of 24 or higher on the Mini-Mental Status Examination. The study is currently listed as not yet recruiting.
Upper extremity paresis or weakness is a frequent impairment following a stroke, and motor or functional recovery remains poor for patients with severe hand impairments despite intense rehabilitation. While adaptive functional electrical stimulation is a promising treatment for facilitating active movement, the combined effect of combining tRNS and adaptive FES in patients with severe hand impairments has not been previously investigated.
The study will measure several primary outcomes, including changes in the Upper Extremity Fugl-Meyer Scale, the Stroke Impact Scale - Hand Function Score, and transcranial magnetic stimulation-induced motor evoked potentials. These measurements will be assessed 6 to 9 weeks post-intervention.
