Clinical Trial

Control Interfaces for Operating Assistive Devices

Study acronym: SENSORS
Recruiting
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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.
Trial Details
NCT Number NCT07058506
Lead Sponsor Centre Bouffard Vercelli - USSAP
Collaborators: NEURINNOV, Institut National de Recherche en Informatique et en Automatique
Conditions Tetraplegia
Enrollment 30 participants
Start Date 2024-11-18
Primary Completion 2024-11-18 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-10