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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

Qualifiers

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;

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Evaluation of neuroprosthesis control methods
  • Neuroprosthesis implantation
  • Pre-use assessments of the neuroprosthesis in a hospital setting
  • Post-use assessments of the neuroprosthesis in a hospital setting
  • Pre-use assessments of the neuroprosthesis at home
  • Post-use assessments of the neuroprosthesis at home
  • Objective and quantified evaluation of the use of the paretic upper limb
  • Post-use assessments of neuroprostheses in a hospital setting

Treatment groups

2 Participants
are divided into 1 treatment group

Sponsors and collaborators