The University of Utah is launching a new clinical study to investigate whether combining transcranial random noise stimulation with functional electrical stimulation can enhance hand function for individuals suffering from chronic stroke. The research, conducted by the Neural Plasticity Rehabilitation and Movement Dynamics (NeRD) Lab, seeks to determine if this multimodal approach is more effective than functional electrical stimulation alone.
Study Objectives and Methodology
The experimental randomized study targets individuals with severe hand impairments, specifically addressing upper extremity paresis or weakness, which is a frequent impairment following a stroke. Researchers are investigating whether combining transcranial random noise stimulation (tRNS) with functional electrical stimulation (FES)-facilitated task practice provides superior recovery of function in the more-affected hand compared to using FES alone.
Experimental Design and Training
According to clinical trial details, the study involves 18 treatment sessions delivered over a period of 6 to 8 weeks, with sessions occurring three times per week. Participants will be randomized into two groups: one receiving the combined tRNS and FES-assisted task-specific practice, and a comparator group receiving a sham-tRNS alongside FES-assisted task-specific practice. The FES-assisted practice focuses on restoring movement components that make up functional tasks, utilizing motor learning principles such as high repetition, task specificity, and attention to the motor task.
Timeline and Projections
The study is scheduled to begin with an estimated start date of Nov. 2, 2026, and is expected to reach primary completion by Dec. 1, 2030. The final study completion is estimated for Feb. 15, 2031. Investigators anticipate that the combination of tRNS and FES will significantly enhance hand function for the target population.
Research Lab Leadership
The NeRD Lab, which is part of the University of Utah College of Health, is led by Lab Director Amit Sethi, PhD, OTR/L. Dr. Sethi is a licensed occupational therapist with over 20 years of clinical and research experience in rehabilitation sciences, specializing in neuromodulation, biomechanics, motor control, and neurorehabilitation. The lab's research focuses on developing and testing new treatments to improve arm and hand function after a stroke.
Laboratory Personnel
The laboratory team includes several specialists and researchers. Elizabeth Forth, a licensed physical therapist with over 17 years of clinical experience, serves as a lab staff member specializing in participant recruitment and enrollment. The research team also includes Gavin Sueltz, who supports motion-capture efforts and experimental test rigs; Mukunth Balaramachandran Srinivasan, who is involved in the development of digital assessment of functional cognition; and Brayden Stidham, a graduate student specializing in Mechatronics who designs and fabricates test fixtures for assessing recovery methods.
Participant Eligibility Criteria
Eligibility for the study is restricted to specific demographics and health conditions. Potential participants must be between 40 and 85 years of age and have received a diagnosis of their first-ever subcortical stroke. To qualify, the stroke must have occurred at least six months prior to participation. Additionally, participants must demonstrate limited functional wrist and finger flexion and extension, specifically between 5 to 20 degrees of active movement, and must have cognitive skills indicated by a score of 24 or higher on the Mini-Mental Status Examination.
Exclusion Factors for Study Participants
Several exclusion criteria have been established for the study. Individuals are ineligible if they have severe aphasia that prevents them from following one-step directions at least 80% of the time, or if they exhibit excessive spasticity in the wrist and finger muscles, defined as a Modified Ashworth Score greater than 2. Other disqualifying factors include having neurological disorders other than stroke, a history of recent seizures or epilepsy while taking anticonvulsants, or having orthopedic or musculoskeletal conditions that affect the upper extremity. Additionally, individuals with metallic implants in the head or neck, or those who are currently pregnant or planning to become pregnant, are excluded.
