Testing Portable Non-Invasive Control Devices to Help People with Tetraplegia Move Their Hands

What this Trial Is About

This research focuses on evaluating non-invasive control interfaces for operating assistive devices in people with tetraplegia, a condition causing paralysis affecting all four limbs. Researchers aim to assess the performance of six different control interfaces that detect user intent to operate a motor neuroprosthesis. These interfaces include voice commands, inertial measurement unit IMU sensors, surface electromyography EMG sensors, a switch button, a joystick, and an Ear-Switch sensor. The goal is to determine if participants can effectively use at least two of these interfaces to control motor actions in a consistent software environment. Participants will go through six study sessions over the course of the trial. The process starts with a selection visit and an inclusion visit, which includes clinical exams and personalized audio recordings for speech recognition. Then, three experimental visits assess all six control interfaces, followed by detailed evaluation of the two best interfaces, including their combined use. The final visit involves a clinical and psychological follow-up to ensure safety. The study focuses on fully portable interfaces designed to be part of a future implanted medical device for daily use. Throughout the study, participants will perform tasks to test the accuracy and reliability of the control interfaces, including modulating movement intensity shown on a screen. Researchers will assess clinical performance, ease of use, user feedback, pain, adverse effects, and satisfaction with the interfaces. Outcome measures include efficacy indicators on the first day and various feasibility and tolerance indicators across sessions. The study aims to confirm that these interfaces can support daily use for individuals with tetraplegia.

Control Interfaces for Operating Assistive Devices