Recruiting

trns & FES

Sponsor:

University of Utah

Code:

NCT07887880

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

tRNS (Transcranial Random Noise Stimulation)

FES (Functional Electrical Stimulation)-assisted task-specific practice

Sham-tRNS (Transcranial Random Noise Stimulation)

Study Details

Brief summary:

Upper extremity (UE) paresis or weakness is one of the most frequent impairments after stroke. Despite intense rehabilitation, motor and functional recovery of patients with severe hand impairments is poor. Hence, there is a need for more effective treatments to enhance motor function in patients with severe hand impairments after stroke. Adaptive functional electrical stimulation (FES) appears to be a promising treatment and has the potential to facilitate active movement in individuals with severe impairments post-stroke. In addition, transcranial random noise stimulation (trns) is a widely studied, non-invasive and safe method to enhance the corticomotor excitability in individuals with chronic stroke. However, the effect of combining trns and adaptive FES in patients with severe hand impairments has not been investigated. Therefore, the purpose of this study is to investigate whether combining trns with FES will enhance hand function in individuals with chronic stroke than FES alone. The investigators predict that combining trns with FES will significantly enhance hand function than FES alone.

Conditions

Stroke

Study ID

NCT07887880

Start date

Nov 11, 2026

Status verified date

Nov, 2026

Completion date

Feb 15, 2031

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Female and male subjects are eligible for inclusion only if all of the following criteria are met:

1. Age between 40-85 years
2. Diagnosis of first-ever subcortical stroke (single cerebrovascular accident)
3. Stroke onset of at least six months prior to the time of participation
4. Limited functional wrist and finger flexion and extension, as indicated between 5º-20º active movement
5. Cognitive skills to actively participate, as indicated by scores of ≥ 24 on the Mini-Mental Status Examina-tion
6. English speaking

Exclusion Criteria:

A subject is not eligible for inclusion if any of the following criteria apply:

1. Presence of severe aphasia preventing the ability to follow 1-step directions at least 80% of the time
2. Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score >2
3. Diagnosis of neurological disorders other than stroke
4. History of recent seizure or epilepsy while taking anticonvulsants
5. Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity
6. Presence of metallic implants in the head or neck
7. Currently or planning to become pregnant
8. Difficulty maintaining alertness or remaining still
9. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for MRI)
10. Bodyweight > 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)
11. Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medication
12. Participation in concurrent occupational therapy

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: sham-tRNS and FES-assisted task-specific practice

Participants will receive the intervention 3x/week for 6-8 weeks for a total of 18 intervention sessions. Participants will receive sham-tRNS during the FES-assisted task-specific practice.

experimental: tRNS and FES-assisted task-specific practice

Participants will receive the intervention 3x/week for 6-8 weeks for a total of 18 intervention sessions. Participants will receive tRNS during the FES-assisted task-specific practice.

Interventions

tRNS (Transcranial Random Noise Stimulation)

Individuals in this group will receive tRNS at 2 mA intensity between 101-640 Hz. The current will be gradually ramped up for and down for the first and last 30 seconds of the stimulation.

FES (Functional Electrical Stimulation)-assisted task-specific practice

The FES-assisted task-specific practice will focus on restituting the movement components composing functional tasks. We will use the principles of motor learning with FES-assisted task-specific practice. Based on motor learning principles, our intervention will include 1) movement practice as close to normative as possible, 2) a high number of repetitions, 3) attention to the motor task, and 4) training specificity.

Sham-tRNS (Transcranial Random Noise Stimulation)

Individuals in this group will receive sham-tRNS via the same electrode configuration as the tRNS. The stimulation will gradually ramp up for 30 seconds and then fade away for the rest of the intervention session.

Primary outcome measure

  • Upper Extremity Fugl-Meyer Scale [ Time Frame: 6-9 weeks post-intervention ]
  • Stroke Impact Scale - Hand Function Score [ Time Frame: 6-9 weeks post-intervention ]
  • Transcranial Magnetic stimulation-induced motor evoked potential [ Time Frame: 6-9 weeks post-intervention ]

Central Contacts and Locations

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

More Information

Sponsor

University of Utah

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • Stroke
  • Hand
  • Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by University of Utah on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.