Control Interfaces for Operating Assistive Devices

Recruiting now · Not applicable

Conditions studied: Tetraplegia

In brief

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.

Key facts

Study ID

NCT07058506

Run by

Centre Bouffard Vercelli - USSAP

People needed

30

Starts

2024-11-18

Expected to finish

2025-12-31

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Rehabilitation Center Bouffard-Vercelli USSAP — Perpignan, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.