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New device hopes to spark recovery in stroke patients

NCT ID NCT02098265

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2010

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53706, United States

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