Control Interfaces for Operating Assistive Devices

NCT07058506 | Recruiting

• 2 other identifiers: 2024-A01014-43101099916
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Neurinnov, in collaboration with the CBV USSAP center and the CAMIN INRIA team, has conducted clinical investigations using various control interfaces, including EMG, IMU, contact sensors, and voice commands, to operate a motor neuroprosthesis. This neuroprosthesis is based on neural electrical stimulation, enabling the activation of multiples muscles via a single electrode. The clinical investigations have successfully demonstrated the feasibility of achieving grasping movements induced by neural electrical stimulation, which are controlled by the participant through external interfaces. These external interfaces were based on existing technologies but were only suitable for research purposes due to their lack of portability. The current investigation aims to validate fully portable interfaces designed by Neurinnov, which are intended to be integral components of a future medical device that includes an implanted stimulator and its neural electrodes. The study's goal is to demonstrate that these interfaces can be used by participants with sufficient success rate (clinical performance) to support daily use. Our main hypothesis is that the participants can effectively use at least two of the six control interfaces presented to them to detect their intention to perform a motor action within a software environment under constant conditions. These interfaces include voice commands, inertial measurement unit (IMU) sensors, surface electromyography (EMG) sensors, switch, joystick, and earswitch.

Conditions

Tetraplegia

Keywords

Tetraplegia; Non-invasive control interfaces; Sensors

Outcome Measures

Primary Outcomes (1)

• Efficacy indicators

  Success rate: describes the ability of a control interface to execute requested functions under specified conditions Evaluation criterion: (Number of correctly recognized commands) / (Number of correctly recognized commands + Number of incorrectly recognized commands). Rate in percentage %

  At Day 1

Secondary Outcomes (12)

• Time workload indicators

  At Day 1

• Indicator of feasibility: Ease of installation, calibration, and learning of each control interface (CI)

  At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4

• Indicator of feasibility: Ease of placing the control interface

  At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4

• Indicator of feasibility: Ease of learning to use the control interface

  At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4

• Indicator of feasibility: User feedback concerning usability of the control interface

  At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4

Study Arms (1)

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

EXPERIMENTAL

Device: Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis

Interventions

Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis DEVICE

No intervention

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 C score (AIS A, B or C): complete or incomplete motor deficit below the lesion. This is a standard for describing spinal cord 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
• NEURINNOV: collaborator
• Institut National de Recherche en Informatique et en Automatique: collaborator

Study Sites (1)

Rehabilitation Center Bouffard-Vercelli USSAP

Perpignan, 66000, France

RECRUITING

Related Publications (6)

• 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

• 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

• 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, 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

• 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

• 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

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Charles FATTAL, MD, PhD

  Centre Bouffard Vercelli - USSAP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles FATTAL Charles FATTAL, MD, PhD

CONTACT

+33 430441100; cfattal@ussap.fr

David GUIRAUD, PhD

CONTACT

33 0434348028; david.guiraud@neurinnov.com

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 6, 2025
• First Posted: July 10, 2025
• Study Start: November 18, 2024
• Primary Completion: November 18, 2024
• Study Completion: December 31, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)