Pilot Study: Home Use of Wearable Grasping Neuroprosthesis in Vascular Hemiparesis

Recruiting now · Not applicable

Conditions studied: Stroke, Réhabilitation

In brief

Stroke is the leading cause of acquired motor disability in adults. Six months post-stroke, 50% of patients have not regained active finger extension, and 80% retain a grasping deficit, most commonly an inability to actively open the hand. This motor impairment significantly impacts daily activities, social interactions, professional life, and overall quality of life. Despite numerous treatments available in rehabilitation centers during the subacute phase, no functional assistive devices are currently usable at home. Since 2018, our team, in collaboration with the CAMIN-INRIA team, has developed a Grasp Neuroprosthesis (GNP). This device uses functional electrical stimulation to restore grasping function in hemiplegic subjects, enhancing autonomy in daily bimanual tasks. The GNP has been evaluated in hospital settings through two studies, defining preferred control modalities and demonstrating significant functional impact. Additionally, another study tested a wearable version of the GNP used autonomously at home for two months. This study showed the feasibility and functional benefits of home GNP use, provided the device is customizable to the patient's characteristics and environment. Initial results indicate improved quality of life and increased autonomy with GNP use. The wearable GNP consist of a forearm orthosis made of soft fabric, integrating an electrode array and a stimulator (CE medical marking for home use), connected via WiFi to a microprocessor positioned in a pouch. The microprocessor incorporates information from inertial measurement units and a microphone, allowing the user to control the electrical stimulator on demand. The stimulation targets the extensor muscles of the long fingers and the thumb, enabling the user to open the hand on demand. We propose extending the home use of the GNP to two patients for one year. Each subject will be followed for one year, with evaluations in a hospital setting at the beginning and end of the period, monthly follow-ups at home throughout the year, and on-demand video consultations.

Key facts

Study ID

NCT07500480

Run by

University Hospital, Toulouse

People needed

2

Starts

2026-04-20

Expected to finish

2027-04-30

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 is running

• University Hospital Toulouse — Toulouse, France (enrolling)
• David GASQ — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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