NCT07058506 Control Interfaces for Operating Assistive Devices
| NCT ID | NCT07058506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Bouffard Vercelli - USSAP |
| Condition | Tetraplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2024-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-11-18 with a primary completion date of 2024-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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). 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.
Contact & Investigator
Charles FATTAL, MD, PhD
PRINCIPAL INVESTIGATOR
Centre Bouffard Vercelli - USSAP
Frequently Asked Questions
Who can join the NCT07058506 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tetraplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07058506 currently recruiting?
Yes, NCT07058506 is actively recruiting participants. Contact the research team at cfattal@ussap.fr for enrollment information.
Where is the NCT07058506 trial being conducted?
This trial is being conducted at Perpignan, France.
Who is sponsoring the NCT07058506 clinical trial?
NCT07058506 is sponsored by Centre Bouffard Vercelli - USSAP. The principal investigator is Charles FATTAL, MD, PhD at Centre Bouffard Vercelli - USSAP. The trial plans to enroll 30 participants.