Virtual Reality Assessment of Control Interfaces for the Use a Neuroprosthesis in Individuals With Tetraplegia

NCT07642804 | Completed

• 2 other identifiers: 2025-A01444-45101099916
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intervention Study

Keywords

tetraplegia; upper limb; functional electrical stimulation; neuroprosthesis; virtual reality; control interfaces

Outcome Measures

Primary Outcomes (1)

• Efficacy indicators

  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

Secondary Outcomes (5)

• Time workload indicators

  At day 1

• Indicators of satisfaction, comfort, pleasure of use and subjective workload

  At day 1

• Indicators of satisfaction, comfort, pleasure of use and subjective workload

  At day 1

• Indicator of appropriation: quality of the embodiement in the VR environment Appropriation

  At day 1

• Indicator of tolerance: cyberkinetosis

  At day 1

Study Arms (1)

Patients with complete tetraplegia AIS A or B, with a neurological level ≥ C7

EXPERIMENTAL

Device: Virtual reality used as a simulation tool to evaluate and optimize the use of control interfaces

Interventions

Virtual reality used as a simulation tool to evaluate and optimize the use of control interfaces DEVICE

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.

Patients with complete tetraplegia AIS A or B, with a neurological level ≥ C7

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Bouffard Vercelli - USSAP: lead
• Institut National de Recherche en Informatique et en Automatique: collaborator

Study Sites (1)

Rehabilitation Center Bouffard-Vercelli USSAP

Perpignan, 66000, France

Location

Related Publications (8)

• Moullet, E., Carpentier, J., Azevedo-Coste, C., & Bailly, F. (2024, November). I-GRIP, a Grasping Movement Intention Estimator for Intuitive Control of Assistive Devices. In 2024 IEEE-RAS 23rd International Conference on Humanoid Robots (Humanoids) (pp. 957-964).

  BACKGROUND

• Fonseca L, Tigra W, Navarro B, Guiraud D, Fattal C, Bo A, Fachin-Martins E, Leynaert V, Gelis A, Azevedo-Coste C. Assisted Grasping in Individuals with Tetraplegia: Improving Control through Residual Muscle Contraction and Movement. Sensors (Basel). 2019 Oct 18;19(20):4532. doi: 10.3390/s19204532.

  PMID: 31635286 BACKGROUND

• Fonseca L, Bo A, Guiraud D, Navarro B, Gelis A, Azevedo-Coste C. Investigating Upper Limb Movement Classification on Users with Tetraplegia as a Possible Neuroprosthesis Interface. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:5053-5056. doi: 10.1109/EMBC.2018.8513418.

  PMID: 30441476 BACKGROUND

• Tigra W, Dali M, William L, Fattal C, Gelis A, Divoux JL, Coulet B, Teissier J, Guiraud D, Azevedo Coste C. Selective neural electrical stimulation restores hand and forearm movements in individuals with complete tetraplegia. J Neuroeng Rehabil. 2020 May 19;17(1):66. doi: 10.1186/s12984-020-00676-4.

  PMID: 32429963 BACKGROUND

• Fonseca L, Guiraud D, Hiairrassary A, Fattal C, Azevedo-Coste C. A Residual Movement Classification Based User Interface for Control of Assistive Devices by Persons With Complete Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2022;30:569-578. doi: 10.1109/TNSRE.2022.3156269. Epub 2022 Mar 21.

  PMID: 35235517 BACKGROUND

• Coste CA, William L, Fonseca L, Hiairrassary A, Andreu D, Geffrier A, Teissier J, Fattal C, Guiraud D. Activating effective functional hand movements in individuals with complete tetraplegia through neural stimulation. Sci Rep. 2022 Oct 6;12(1):16189. doi: 10.1038/s41598-022-19906-x.

  PMID: 36202865 BACKGROUND

• Fattal C, Teissier J, Geffrier A, Fonseca L, William L, Andreu D, Guiraud D, Azevedo-Coste C. Restoring Hand Functions in People with Tetraplegia through Multi-Contact, Fascicular, and Auto-Pilot Stimulation: A Proof-of-Concept Demonstration. J Neurotrauma. 2022 May;39(9-10):627-638. doi: 10.1089/neu.2021.0381. Epub 2022 Feb 2.

  PMID: 35029125 BACKGROUND

• Azevedo Coste C, Guiho T, Ferreira F, Bailly F, Degeorge B, Geffrier A, Andreu D, Teissier J, Guiraud D, Fattal C. Restoring hand grasping for patients with a complete tetraplegia with selective epineural stimulation: a parsimonious thus relevant clinical approach. J Neuroeng Rehabil. 2026 Jan 14;23(1):111. doi: 10.1186/s12984-025-01857-9.

  PMID: 41535942 BACKGROUND

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• CHRISTINE AZEVEDO, PhD

  Institut National de Recherche en Informatique et en Automatique

  STUDY DIRECTOR

• CHARLES FATTAL, MD, PhD

  Centre Bouffard Vercelli - USSAP

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: April 10, 2026
• Primary Completion: May 7, 2026
• Study Completion: May 27, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

FR (1)