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Virtual Reality Assessment of Control Interfaces for the Use a Neuroprosthesis in Individuals With Tetraplegia (I-GRIP)

8. června 2026 aktualizováno: Centre Bouffard Vercelli - USSAP

Relevance of Virtual Reality Assessment of Control Interfaces for a Neuroprosthesis That Stimulates the Upper Limbs of Quadriplegic Individuals

With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices. The operating principle of the device we are interested in is to provide a set of predefined functional electrical stimulation (FES) configurations that activate specific hand movements (hand opening, palmar grasp, key grip, etc.), from which the user selects the one that is suitable for performing a task. The user control is usually based on commands from the contralateral limb (pressing a button, shoulder movement, or voluntary muscle contractions). These stereotypical and unintuitive commands hinder any possibility of bimanual tasks. Hands-free voice interfaces have been tested but have contextual limitations, particularly in terms of discretion or usability for certain activities such as eating. Furthermore, it is difficult to evaluate the performance of control interfaces and adjust them prior to the implantation of the stimulation neuroprosthesis. The aim of the I-GRIP project is to establish a methodology that is sufficiently realistic to enable people to envision their future use of a neuroprosthesis. Such a tool would also enable future candidates for implantation to better understand the device's potential. This approach would also make it possible to customize the technology prior to implantation (choice and adjustment of control interfaces, training, configuration of algorithms for analyzing movements evoked by stimulation, etc.).

Our main hypothesis is that two control interfaces (HMI1 and HMI2) will allow the user to control the completion of a grasping task (approach, grasp, hold) for each target object in the virtual environment simulating electrical stimulation of the forearm muscles.

Přehled studie

Detailní popis

Immersive, semi-immersive, or non-immersive VR has mainly been used for therapeutic rehabilitation purposes in patients with spinal cord injuries who have motor impairments in their upper limbs. A recent literature review in 2024 highlights a strong trend emerging from the analysis of all publications on the subject, namely an analytical gain in strength with no impact on manual dexterity, this gain being all the more significant the longer the training lasted (> 15 hours in total). In the field of functional electrical muscle stimulation, which is of interest to us here, Ajiboye et al. 2017 proposed post-implantation training of an upper limb (UL) stimulation neuroprosthesis in a quadriplegic patient under the control of a Brain Computer Interface (BCI) and compared object grasping performance in immersive VR and non-VR. Given that VR training was longer than non-VR training, movements were found to be smoother and more precise in VR. The uniqueness of this experiment lies in having established proof of concept around a subject's ability to control single and multi-coordinated movements with 80 to 100% accuracy using their thoughts, first using a virtual upper limb (UL) and then their own UL activated by FES to drink a cup of coffee and bring food to their mouth. It also highlighted the real value of immersive virtual reality in learning movements.

A recent publication of a clinical case study focused on the use of a Leap Motion optical hand tracking controller in a semi-immersive environment [Ahmed Al Nattah 2024]. Leap Motion, which is mainly used in kinematic assessments, is introduced in this publication for the purpose of rehabilitating the hand of an incomplete quadriplegic participant equipped with sensors and invited to perform exercises of increasing difficulty in custom-built video games offering both visual and auditory feedback. Beyond the promising therapeutic benefits observed in this single case study, this semi-immersive experience can be transposed into full immersion in applications such as the optimization and customization of neuroprosthesis control interfaces. VR is playing an increasingly decisive role in movement rehabilitation. It is part of the therapeutic arsenal that now aims to offer a fun, meaningful, and motivating approach to encourage the repetition of gestures and movements and, in fact, learning. However, its use as a tool for designing and evaluating the performance of assistive technology control interfaces has been little explored in studies, which justifies the approach adopted in this project.

With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices. Such an environment would ultimately enable future users to prepare for the use of these devices and to project themselves into their use. This approach would also make it possible to customize the technology prior to implantation (choice and adjustment of control interfaces, training, configuration of algorithms for analyzing movements evoked by stimulation, etc.). In general, it is important to advance control interfaces to improve their ergonomics and usability. Here, we wish to show that virtual reality allows participants to realistically project themselves into an experience of using a neuroprosthesis that controls wrist extension and finger flexion/extension movements.

Participants will be equipped with a virtual reality headset that will project a virtual scene with various everyday objects and a representation of their hand. They will have to move their arm towards one of the objects in the scene, then trigger hand movements using one of the available control interfaces to grasp the object and manipulate it. Two methods of controlling the opening and closing movements of the fingers will be tested: HMI1: two physical buttons activated by pressing with the opposite hand to send commands, and HMI2 - shared control: the reaching movement of the arm towards the object is tracked using a video camera and automatically select the appropriate opening and gripping movements. HMI1 therefore requires a stereotypical action (pressing a button), while HMI2 allows automatic selection of grasping movements by observing the natural movements of approaching the object, which are observed by a camera and interpreted by an algorithm.

The experimental aspects of the study will be conducted over 2 sessions:

  • (V1) Selection Visit: The selection visit will be conducted by the coordinating investigator, who will monitor the participant throughout the trial.
  • (V2) Inclusion Visit: This visit will include: Clinical examination Collection of the signed consent form
  • (V3 to V4) Experimental Visits: V3 (session 1): Taking measurements of the user to customize the models used for the virtual environment (2 hours max) V4 (session 2): Virtual immersion experiment (2 hours max)
  • (V5) End-of-Study Visit: This final visit will consist of a clinical and psychological follow-up consultation to ensure the absence of any adverse effects.

Typ studie

Intervenční

Zápis (Aktuální)

10

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Perpignan, Francie, 66000
        • Rehabilitation Center Bouffard-Vercelli USSAP

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Spinal cord injury defined by an AIS A, B or score (AIS A, B): complete or incomplete motor deficit below the lesion. This is a standard for describing spinalcord injuries that has been internationally agreed upon.
  • Spinal cord injury at the neurological level > C7
  • Age greater than or equal to 18 and less than or equal to 80 years
  • A history of more than 3 months of neurological stability, with no changes in muscle testing.
  • Participants capable of following instructions for testing and providing feedback on the use of the device.
  • Participants who have signed the informed consent form to participate in the study after being fully informed.
  • Participants affiliated with a social security system (either as a beneficiary or a dependent), excluding those covered by State Medical Aid (AME).

Exclusion Criteria:

  • • Participant deprived of liberty (by judicial or administrative decision).

    • Adult participants are under legal protection or unable to provide informed consent.
    • Participation in another ongoing clinical trial.
    • Unstable psychiatric condition.
    • Severe cognitive impairment.
    • Unstable acute medical condition
    • Insufficient proficiency in spoken and written French.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Pacienti s úplným tetraplegií AIS A nebo B, s neurologickou úrovní ≥ C7
With a view to implanting a neuroprosthesis for the upper limb in individuals with complete tetraplegia, this study aims to validate virtual reality as a simulation tool for evaluating and optimizing the piloting interfaces of these type of assistive devices.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Efficacy indicators
Časové okno: At Day 1
Success rate (%) of the task (approach the object, grasp it with the dedicated grip, hold it for 5 seconds) over 10 repetitions for the each control modality. The expected success rate is at least 90% over all 10 repetitions for each control modality after a short learning phase.
At Day 1

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time workload indicators
Časové okno: At day 1
Task execution time (seconds) for each of the HMIs
At day 1
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Časové okno: At day 1

Enjoyability of the control interface, reflecting the user's mood, motivation, or frustration.

Evaluation criterion: For each HMI, after 10 repetitions, appropriate section of the questionnaire National Aeronautics and Space Administration Task Load Index (NASA-TLX). For each item, the score min is 0 and max 100.

At day 1
Indicators of satisfaction, comfort, pleasure of use and subjective workload
Časové okno: At day 1
Measuring the patient experience Evaluation criterion: For each HMI, after 10 repetitions, appropriate section of the questionnaire PREMs.
At day 1
Indicator of appropriation: quality of the embodiement in the VR environment Appropriation
Časové okno: At day 1
Appropriation indicator - Virtual Embodiment Questionnaire (VEQ) (French version) before and after personalization of the environment
At day 1
Indicator of tolerance: cyberkinetosis
Časové okno: At day 1
SSQ - Simulator Sickness Questionnaire (French version) at the end of the experiment
At day 1

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: CHARLES FATTAL, MD, PhD, Centre Bouffard Vercelli - USSAP
  • Ředitel studie: CHRISTINE AZEVEDO, PhD, Institut National de Recherche en Informatique et en Automatique

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. dubna 2026

Primární dokončení (Aktuální)

7. května 2026

Dokončení studie (Aktuální)

27. května 2026

Termíny zápisu do studia

První předloženo

8. června 2026

První předloženo, které splnilo kritéria kontroly kvality

8. června 2026

První zveřejněno (Aktuální)

11. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2025-A01444-45
  • 101099916 (Jiné číslo grantu/financování: HORIZON-EIC-2022-PATHFINDEROPEN-01-01)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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