Clinical trial NCT03946488: Functional Impact of a Closed-loop Controlled Grasping Neuroprosthesis in Post-stroke Patients (PREHENSTROKE)
Official title: Évaluation Des modalités Optimales de Pilotage et de l'Impact Sur Les capacités de préhension d'Une Stimulation électrique Fonctionnelle Des Muscles Extenseurs Des Doigts Chez le Patient hémiplégique en Phase Chronique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand function restoration
Prehension
Closed-loop controlled neuroprosthesis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche en Informatique et en Automatique
First posted: 2019-05-10
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Stroke is the leading cause of disability in adults. The improvement of the grasp abilities remains a challenge in the 50% of post-stroke subjects who have not recovered functional grasping due to paralysis of the finger's muscles (lack of active opening of the hand).

The use of functional electrical stimulation of the prehension muscles in order to restore grasp abilities, called grasp neuroprosthesis (GP), remained confidential in post-stroke subjects while their development was important in tetraplegic subjects. GP can provide a correct hand opening with significant functional gain, but one of the major issues corresponds to the control modalities that are not adapted to the specific impairments of post-stroke subjects.

This project proposes to assess the functional contribution of an innovative autopilot closed-loop GP targeting the extensor muscles of the fingers. The main hypothesis is that the use of GP will restore grasping abilities in subjects who have lost this ability due to post-stroke paralysis.

The main objective is to assess the impact of using an autopilot closed-loop GP on the ability to perform a standardized task of grasping, moving and releasing either a glass (palmar grasp) or a spoon (key pinch), compared to the absence of GP use.

The secondary objectives of the study are: (1) to assess the impact of the GP on unimanual grasp; (2) to assess which are the preferential modes of control; (3) to assess the psycho-social impacts of GP, and (4) to assess the subject's satisfaction and tolerance to the characteristics and use of GP.

The investigators plan to include 20 post-stroke hemiplegic subjects over a period of 9 months as part of a prospective, monocentric, multi-crossover, blinded evaluation study. Subjects will have active finger extension deficit secondary to stroke, with preservation of proximal movements. Each subject will be his own control (self-pairing).

Each subject will be evaluated three times, the protocol adding approximately 1½ hours of daily assessment to routine care already received. The first visit will collect clinical data after informed consent collection. The second visit will allow to choose the optimal mode of control of the GP among 8 modalities. The third visit will test the functional gain provided by the use of GP, by comparing the success or failure of carrying out functional tasks with inactive and active GP.


Eligibility criteria: Inclusion Criteria:

* The patient must have given free and informed consent and signed the consent;
* The patient must be an affiliate or a beneficiary of a health insurance plan;
* The patient is hospitalized as part of routine care and available for at least 3 consecutive days of follow-up during hospitalization;
* Motor deficiency of the upper limb due to a hemorrhagic or ischemic stroke;
* Stroke more than one months old;
* Inability to perform an active extension of the long fingers (opening of the hand) to voluntarily seize an empty glass with a palmar grip (grasping task in the ARAT scale), while the subject can hold the previously placed glass passively in the hand; and / or
* Inability to perform an active thumb extension to voluntarily grasp the handle of a tablespoon (flat, like a key) with a pulpo-lateral thumb-index or key-grip (grasping task in the Wolf Motor Function Scale Test), while the subject can hold the spoon previously placed passively between thumb and index;
* Ability to sit on a chair for at least 2 hours.

Exclusion Criteria:

* The subject participates in another interventional study;
* The subject is in an exclusion period determined by a previous study;
* The subject is under the protection of justice, guardianship or curatorship;
* The subject refuses to sign or give consent;
* It is not possible to give the subject enlightened information.
* The patient is pregnant, parturient, or breastfeeding;
* Patient with pacemaker;
* Unstable epilepsy;
* Unstable cardiovascular pathology (coronary heart disease, major hypertension, heart failure);
* Dermatological problems counter-indicating the application of surface electrodes;
* Musculotendinous retractions or joint stiffness of the fingers and wrist preventing passive opening of the hand sufficient to perform the functional tasks evaluated;
* Active elbow extension limited to not reaching the ipsilateral knee, the subject sitting (limitation of the approach);
* Upper limb pain limiting movements;
* Major sensory disorders corresponding to a score of the Modified Erasmus Nottingham Sensory Assessment English version of the upper limb \<10/44;
* Severe aphasia with aphasia severity scale of the Boston Diagnostic Severity Aphasia Examination \<= 3, 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 bell test if the difference between omissions in the left and right fields is greater than or equal to 6;
* Common extensor digitorum muscle and / or extensor thumb muscle non-stimulable with the neuroprosthesis.

Primary outcomes:
measure: Rate of success of the main functional task
timeFrame: Third day
Secondary outcomes:
measure: Rate of success of the secondary functional task
timeFrame: Third day
measure: Comparison of the Action Research Arm Test (ARAT) performed with the inactivated (first day) and activated (day three) neuroprosthesis
timeFrame: First and third day
measure: Psychosocial Impact of Assistive Devices (PIADS) questionnaire
timeFrame: Third day
measure: Subscale "Device" from the questionnaire Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
timeFrame: Third day
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
city: Toulouse
country: France
facility: CHU de TOULOUSE
Study officials:
affiliation: Institut National de Recherche en Informatique et en Automatique
name: Christine Azevedo, PhD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Jérôme Froger, MD
role: PRINCIPAL_INVESTIGATOR
References: