New device hopes to spark recovery in stroke patients
NCT ID NCT02098265
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
This study is testing whether a device that uses mild electrical pulses to stimulate arm muscles and the tongue can help stroke survivors regain arm movement. Researchers will enroll 288 participants, including stroke patients with arm weakness and healthy controls. The main goal is to see if the device improves arm function over about four months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Functional Electric Stimulation (FES) device
- What this could lead to
- If successful, this could point toward a new, non-invasive way to improve arm movement and daily function in stroke survivors.
- What could go wrong
- This is an early-stage study with no phase, so results are uncertain. The device may not provide meaningful improvement over standard rehab, and individual responses can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 288 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2010
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (Experimental Group): * Stroke patients with persistent upper extremity (UE) deficits Inclusion Criteria (Control Group 1) * Stroke patients without UE impairments * Participants with risk factors for stroke * healthy controls * No known neurologic, psychiatric or developmental disability Inclusion Criteria (Control Group 2) * Stroke patients with persistent upper extremity (UE) deficits * Moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45) * No upper extremity injury or conditions that limited use prior to the stroke * Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention. Exclusion Criteria (for all participants): * Allergic to electrode gel, surgical tape and metals * Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study * Women who are pregnant or may become pregnant during the course of the study will be excluded * Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing) Exclusion Criteria (for healthy controls) * Contraindications for MRI * Allergic to electrode gel, surgical tape, and metals.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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University of Wisconsin
RECRUITINGMadison, Wisconsin, 53706, United States
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