Status:
RECRUITING
Assessment of the Functional Impact of a Close-loop Controlled Prehension Neuroprosthesis in Post-stroke Patients
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the PREHENS-STROKE study is to propose a functional replacement device to restore grip capacities in patients with hemiparesis after stroke, unable to actively open the hand to seize object...
Detailed Description
Stroke is the leading cause of motor impairment acquired after 40 years. Of the affected patients, 50% do not recover active finger extension and there is no satisfactory solution for functional recov...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04804384
Start Date
August 30 2021
End Date
December 30 2025
Last Update
October 23 2024
Active Locations (1)
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1
University Hospital
Toulouse, France, 31500