StrokeNCT07887880
A Novel Multimodal Approach to Promote Motor Recovery and Plasticity After Stroke
A study testing tRNS (Transcranial Random Noise Stimulation) and FES (Functional Electrical Stimulation)-assisted task-specific practice in people with Stroke, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- tRNS (Transcranial Random Noise Stimulation) and FES (Functional Electrical Stimulation)-assisted task-specific practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 15 Feb 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male subjects are eligible for inclusion only if all of the following criteria are met:
- Age between 40-85 years
- Diagnosis of first-ever subcortical stroke (single cerebrovascular accident)
- Stroke onset of at least six months prior to the time of participation
- Limited functional wrist and finger flexion and extension, as indicated between 5º-20º active movement
- Cognitive skills to actively participate, as indicated by scores of ≥ 24 on the Mini-Mental Status Examina-tion
- English speaking
Who cannot join
- A subject is not eligible for inclusion if any of the following criteria apply:
- Presence of severe aphasia preventing the ability to follow 1-step directions at least 80% of the time
- Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score >2
- Diagnosis of neurological disorders other than stroke
- History of recent seizure or epilepsy while taking anticonvulsants
- Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity
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- Presence of metallic implants in the head or neck
- Currently or planning to become pregnant
- Difficulty maintaining alertness or remaining still
- Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for MRI)
- Bodyweight > 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)
- 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
- Participation in concurrent occupational therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The primary purpose of this study was to investigate whether combining transcranial random noise stimulation with functional electrical stimulation-facilitated task practice will enhance hand function in individuals with severe paresis post-stroke than functional electrical stimulation alone.
The study is an experimental randomized study comparing the effects of transcranial random noise stimulation with functional electrical stimulation to functional electrical stimulation alone on recovery of function in the more-affected hand in individuals with chronic stroke.
Participants were randomized to receive transcranial random noise stimulation and functional electrical stimulation-facilitated task practice or sham-transcranial random noise stimulation and functional electrical stimulation-facilitated task practice.
Participants received 18 treatment sessions over 6 weeks (3 times/week for 6-8 weeks).
- Conditions
- Stroke
- Being tested
- tRNS (Transcranial Random Noise Stimulation), FES (Functional Electrical Stimulation)-assisted task-specific practice, Sham-tRNS (Transcranial Random Noise Stimulation)
- Keywords
- Stroke, Hand, Brain Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tRNS (Transcranial Random Noise Stimulation)Device
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 practiceDevice
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| sham-tRNS and FES-assisted task-specific practice | Sham comparator | 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. Receives: Device: FES (Functional Electrical Stimulation)-assisted task-specific practice; Device: Sham-tRNS (Transcranial Random Noise Stimulation) |
| tRNS and FES-assisted task-specific practice | Experimental | 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. Receives: Device: tRNS (Transcranial Random Noise Stimulation); Device: FES (Functional Electrical Stimulation)-assisted task-specific practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugl-Meyer Scale
Changes in Upper Extremity Fugl-Meyer between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. This scale measures voluntary motor control of the paretic upper extremity (UE) using a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. The total possible score ranges from 0-66 with higher scores indicating a better voluntary motor control of the paretic UE.
Measured: 6-9 weeks post-intervention
Stroke Impact Scale - Hand Function Score
Changes in Stroke Impact Scale - Hand Function Score between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Participants report paretic upper extremity (UE) use in five commonly performed daily tasks (e.g., carry a bag of groceries) using a 5-point ordinal scale, which ranges from 0-5, where 0=cannot use paretic and 5=not difficult at all to use paretic UE. The total score ranges from 0-25 with higher scores indicating better UE function.
Measured: 6-9 weeks post-intervention
Transcranial Magnetic stimulation-induced motor evoked potential
Changes in cortical motor evoked potentials (MEPs) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. MEPs will be obtained by placing a transcranial magnetic stimulation (TMS) coil over the hand knob of the ipsilesional primary motor cortex. TMS-induced MEP amplitude will be obtained by averaging peak to peak amplitudes of 20 MEPs from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of MEP indicate greater corticospinal excitability.
Measured: 6-9 weeks post-intervention
Secondary outcomes (3)
Upper Extremity Fugl-Meyer Scale
Changes in Upper Extremity Fugl-Meyer between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. This scale measures voluntary motor control of the paretic upper extremity (UE) using a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. The total possible score ranges from 0-66 with higher scores indicating a better voluntary motor control of the paretic UE.
Measured: 12-14 weeks post intervention
Stroke Impact Scale - Hand Function Score
Changes in Stroke Impact Scale - Hand Function Score between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Participants report paretic upper extremity (UE) use in five commonly performed daily tasks (e.g., carry a bag of groceries) using a 5-point ordinal scale, which ranges from 0-5, where 0=cannot use paretic and 5=not difficult at all to use paretic UE. The total score ranges from 0-25 with higher scores indicating better UE function.
Measured: 12-14 weeks post intervention
Transcranial Magnetic stimulation-induced motor evoked potential
Changes in cortical motor evoked potentials (MEPs) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. MEPs will be obtained by placing a transcranial magnetic stimulation (TMS) coil over the hand knob of the ipsilesional primary motor cortex. TMS-induced MEP amplitude will be obtained by averaging peak to peak amplitudes of 20 MEPs from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of MEP indicate greater corticospinal excitability.
Measured: 12-14 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion15 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Sethi, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887880
- Sponsor's protocol ID
- 00193557
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes