Assessment of the Functional Impact of a Close-loop Controlled Prehension Neuroprosthesis in Post-stroke Patients

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Mar 15, 2021

Keywords

ClinConnect Summary

The PREHENS-STROKE clinical trial is studying a new device designed to help patients who have lost the ability to open their hand after a stroke, a condition known as hemiparesis. The goal of the trial is to see if this special device can help patients grasp, move, and release objects like a glass or a spoon more effectively than without using the device. Participants will be asked to try these tasks with and without the neuroprosthesis, which is a device that works to stimulate the muscles in the hand.

To be eligible for the study, participants need to be at least 18 years old and have experienced a stroke more than a month ago that has affected their ability to use their hand. They should be able to sit for about an hour and a half during the trial. However, those who are pregnant, have certain severe health conditions, or have difficulties that prevent them from using the device will not be able to participate. If someone is interested in joining the trial, they will need to sign a consent form and will receive care during their participation. This study aims to improve hand function and independence for individuals recovering from a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Concerning the study population: Paresis of an upper limb from a single ischemic or hemorrhagic, hemispheric or brainstem stroke, as evidenced by brain imaging (CT or MRI); Stroke more than one month old; Impossibility to actively expand the fingers 2 to 5 (opening of the hand) to intentionally grab an empty glass (identical to the material used for the Action Research scale Arm Test), with a palmar grip (cylindrical grip), while the subject can hold the glass passively placed in the hand and/or the thumb to voluntarily grab the handle of a tablespoon (flat, like a wrench) with a key-grip (identical to that of the Wolf Motor Function Test), while the subject can hold the spoon previously placed passively between thumb and index; Ability to sit on a chair at least during 1h30.
• • Concerning legislative aspects: Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any investigation required by the research); Affiliate or beneficiary of the French health insurance system; The person is of age (at least 18 years old); Women and men are included; The patient is available for a follow-up of 5 days as part of his hospitalization performed as part of routine care.
• Exclusion Criteria:
• • Concerning the study population: The person is parturient, or is breastfeeding; The person is pregnant, the diagnosis being guided by the interrogation (date of the last menstruation, desire of pregnancy, contraception) and possibly confirmed by a blood test (beta hCG); Musculotendinous retractions or joint stiffness of the fingers and wrist preventing passive opening of the hand sufficient to perform at least one of the functional tasks evaluated; Limitation of the approach which does not make it possible to carry out the task of gripping in front of the trunk, the subject sitting; Upper limb pain limiting achievement of the primary standardized grasping task; Major sensory disorders corresponding to a sub-score Somesthesia of the modified Erasmus Nottingham Sensory Assessment French version (EmNSA-F) for the upper limb \<10/44; Severe aphasia with aphasia severity scale of the Boston Diagnostic Severity Aphasia Examination, indicating that there may be a clear decrease in verbal fluency or ease and speed of understanding, with no significant limitation expression or communication; Unilateral spatial negligence highlighted with the bells test if the difference between the omissions in the left and right fields is greater than or equal to 6; Extensor digitorum communis muscle and/or pollicis extensor longus muscle not stimulable with the neuroprosthesis, i.e. a sufficient extension of fingers and/or thumb for grasping tasks is not obtained with an electrical stimulation well supported by the patient.
• • Concerning the associated pathologies: The person is carrying a pacemaker; Presence of unstable epilepsy; Presence of unstable cardio-vascular disease (coronary heart disease, major hypertension, heart failure); Presence of a dermatological problem against indicating the application of surface electrodes.
• • Concerning associated treatments: The person should not receive an injection of botulinum toxin in the upper limb during the period of inclusion in the protocol, or in the 30 days prior to inclusion.
• • Concerning legislative aspects: The person is participating in another research protocol including an exclusion period still in progress; The person is under the protection of justice or guardianship; The person refuses to sign the consent; It is not possible to give the person informed information and to make sure of the subject's compliance due to impaired physical and/or psychological health.