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

NCT04804384 | Recruiting

• 1 other identifier: RC31/19/0502
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 objects. The main objective is to evaluate the impact of the use of a self-controlled prehension neuroprosthesis on the ability to perform a standardized grasping task, consisting of grasping, relocating and releasing a glass (palmar grasp) or a spoon (key-pinch), compared to a condition without the use of the prehension neuroprosthesis.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Success rate of a main standardized gripping task performed

  The primary endpoint is a comparison of the success rate of a main standardized gripping task performed with the activated and inactivated prehension neuroprosthesis. This task consists of grasping, moving and releasing either an object with a palmar grasp (glass) or a key grip between thumb and index (to catch the handle of a spoon or a key). During the visit T3, the patient chooses the main functional task from the two standardized tasks (the other becomes the secondary task). The evaluation consists of 24 trials with active or inactive prehension neuroprosthesis (12 activated and 12 inactivated). The criterion selected as a success corresponds to the success of at least 70 percent of the tests, i.e. 8 out of 12 trials in each condition. This success / failure score is made from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis, from data collected during the visit T4 (5th and last day).

  5 days

Secondary Outcomes (9)

• Comparison of success rate

  5 days

• Qualitative analysis

  2 days

• Analysis of the quality

  5 days

• Analysis of the the duration

  5 days

• Comparison of the Action Research Arm Test score

  5 days

Study Arms (1)

Experimental

EXPERIMENTAL

Device: Prehension neuroprosthesis

Interventions

Prehension neuroprosthesis DEVICE

The experimental condition corresponds to patients in the condition where the prehension neuroprosthesis is active, which means that the extensor muscles of the fingers and thumb will be stimulated by the prehension neuroprosthesis to ensure the opening of the hand. The prehension neuroprosthesis designates a functional electrical stimulation device controlled by the patient which will itself trigger the stimulation of the extensor muscles of the fingers (closed-loop control), according to stimuli which it controls voluntarily. The goal is to restore an opening of the fingers to capture objects. The control condition corresponds to the patients in the condition where the prehension neuroprosthesis is inactive.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, 31500, France

RECRUITING

Related Publications (1)

• Le Guillou R, Froger J, Morin M, Couderc M, Cormier C, Azevedo-Coste C, Gasq D. Specifications and functional impact of a self-triggered grasp neuroprosthesis developed to restore prehension in hemiparetic post-stroke subjects. Biomed Eng Online. 2024 Dec 21;23(1):129. doi: 10.1186/s12938-024-01323-y.

  PMID: 39709421 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David GASQ, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David GASQ, MD

CONTACT

5 61 32 28 42; gasq.d@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 18, 2021
• Study Start: August 30, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)