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New wearable device helps stroke patients regain hand function at home

NCT ID NCT07500480

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tests a wearable neuroprosthesis that uses mild electrical stimulation to help stroke survivors open their hand. Two participants will use the device at home for one year to see if it improves daily activities and quality of life. The goal is to understand how well the device works in real-life settings.

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 2 people

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

Started

Apr 2026

Expected to finish

Apr 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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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/ * Adult patient who participated in and completed the GRASP-AGAIN study and achieved functional improvement through the use of NAP. * Motor deficit of an upper limb resulting from a single ischemic or hemorrhagic stroke, hemispheric or brainstem, confirmed by brain imaging (CT scan or MRI); * Brain lesion occurring more than one month prior; * Presence of at least one of the following two disabilities: * Inability to actively extend the long fingers (open the hand) to actively grasp an empty glass (upper and lower diameters of 7 and 6 cm respectively, height of 12 to 15 cm, weight of 125 g, identical to the material used for the Action Research Arm Test scale) with a palmar grip, without the aid of the other hand, while the subject is able to hold the glass passively in the hand; * Inability to actively extend the thumb to grasp the handle of a soup spoon (flat, like a key) without the aid of the other hand, using a thumb-index finger pulp-lateral grip (grasping task in the Wolf Motor Function Test), while the subject can passively hold the handle of a spoon or a key previously placed between the thumb and index finger; * Patient receiving care within the standard healthcare pathway; * Ability to sit in a chair and remain focused for at least 1.5 hours; * Free, informed, and written consent signed by the participant and the investigator (no later than the day of enrollment and before any examination required for the research); * Individual affiliated with or covered by a social security scheme Exclusion Criteria: * The person is in labor or breastfeeding; * The person is pregnant, the diagnosis being guided by questioning (date of last menstrual period, desire for pregnancy, contraception) and possibly confirmed by a blood test for beta hCG; * Musculotendinous contractures or joint stiffness of the fingers and wrist preventing passive opening of the fingers; * Limited approach ability preventing the hand from being positioned in front of the abdomen (without contact) at the level of the midline sagittal plane, while the subject is seated; * Paretic pain in the upper limb limiting the performance of the standardized grasping task; * Major sensory disturbances corresponding to a Somatosensation subscore of the modified Erasmus Nottingham Sensory Assessment French version (EmNSA-F, see Appendix A) upper limb \<10/44; * Severe aphasia with a Boston Diagnostic Severity Aphasia Examination Severity Scale score ≤ 3, see Appendix B, indicating that there may be a marked decrease in verbal fluency or ease and rapidity of comprehension, without significant limitation of expression or communication; * Known gestural apraxia, within the limits of the subject's motor abilities (ideomotor apraxia, ideational apraxia, dressing apraxia, or reflexive apraxia); * Unilateral spatial neglect demonstrated with the bell test (see Appendix B'), if the difference between omissions in the left and right visual fields is greater than or equal to 6; * The extensor digitorum communis and/or extensor pollicis longus muscles cannot be stimulated with the neuroprosthesis, meaning that sufficient extension of the long fingers and/or thumb for grasping tasks is not achieved with electrical stimulation well tolerated by the patient; * The person has a pacemaker; * Presence of uncontrolled epilepsy; * Presence of unstable cardiovascular disease (coronary artery disease, severe hypertension, heart failure); * Presence of a dermatological condition contraindicating the application of surface electrodes; * The person is participating in another research study with an ongoing exclusion period; * The person is under legal guardianship or conservatorship; * The person refuses to sign the consent form; * It proves impossible to provide the person with informed consent and ensure their compliance due to impaired physical and/or psychological health.

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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 places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • David GASQ

    RECRUITING

    Toulouse, France

  • University Hospital Toulouse

    RECRUITING

    Toulouse, 31400, France

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