About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Comparison of 5 interfaces used to capture user intent to operate a neuroprosthesis
DeviceNo intervention
Treatment groups
Trial outcomes
Primary outcomes
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 %
Secondary outcomes
Time workload indicators
Latency between the user's actual intention and its detection, measured in seconds.
Indicator of feasibility: Ease of installation, calibration, and learning of each control interface (CI)
Evaluation criterion: Time tracked by the sensor control software, measured in minutes.
Indicator of feasibility: Ease of placing the control interface
Evaluation criterion: The number of times a third party (participant's caregiver or clinician) needed physical assistance and/or requested additional instructions to position the sensor.
Indicator of feasibility: Ease of learning to use the control interface
Evaluation criterion: The number of repetitions required for the participant to learn the interface. At Day 2 for the points 1, 2 and 3 and at Day 3 for the point 4
Sponsors and contacts
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Centre Bouffard Vercelli - USSAP
Lead sponsor
NEURINNOV
Collaborator
Institut National de Recherche en Informatique et en Automatique
Collaborator