Home-use Grasp Neuroprosthesis for helping with finger opening after stroke
Official title: Pilot Study Evaluating the Usability and Functional Impact of Prolonged Home Use of a Wearable Grasping Neuroprosthesis in Subjects With Vascular Hemiparesis - GRASP-HOME
Run by University Hospital, Toulouse · NCT07500480 · Data updated 2026-11-12
This study tests a wearable grasp neuroprosthesis at home to see if it helps people who have trouble opening their hand after a stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2 (estimated) |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 2 sites (Toulouse and 1 other locations) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07500480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who previously participated in and benefited from the GRASP-AGAIN study and meet criteria for upper-limb motor deficit due to a single stroke more than one month prior.
✕Probably not a fit
Patients without sufficient residual finger extension or unsuitable anatomy may not experience functional benefit from the device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates a wearable grasp neuroprosthesis (GNP) that uses functional electrical stimulation to restore hand opening and grasping in adults with motor impairment after stroke. The device is tested in home and hospital settings to determine the effectiveness of different control methods and overall functional impact. Eligible participants have a history of stroke, persistent upper-limb motor deficit, and specific limitations in finger extension to grasp objects. The study builds on prior hospital-based work and seeks to determine feasibility, safety, and functional benefits in a real-world environment.
Why it matters
Potential benefit: If successful, participants may experience improved ability to grasp and manipulate objects at home, enhancing independence in daily activities.
How similar studies have gone: Previous hospital-based studies of the GNP have demonstrated functional impact and informed control modalities, with ongoing evaluation in home use.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University Hospital Toulouse
Toulouse, France Recruiting -
David GASQ
Toulouse, France Recruiting
Study contacts
- Study coordinator: David GASQ, MD
- Email: gasq.d@chu-toulouse.fr
- Phone: 5 61 34 00 56
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.