Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07058506

Control Interfaces for Operating Assistive Devices

Led by Centre Bouffard Vercelli - USSAP · Updated on 2025-07-10

30

Participants Needed

1

Research Sites

58 weeks

Total Duration

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Sponsors

C

Centre Bouffard Vercelli - USSAP

Lead Sponsor

N

NEURINNOV

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Control Interfaces for Operating Assistive Devices

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Spinal cord injury defined by an AIS A, B or C score (complete or incomplete motor deficit below the lesion)
  • Spinal cord injury at the neurological level above C7
  • Age 18 to 80 years
  • Neurological stability for more than 3 months with no changes in muscle testing
  • Ability to follow instructions for testing and provide feedback on device use
  • Signed informed consent after full information
  • Affiliation with a social security system (excluding State Medical Aid)
Not Eligible

You will not qualify if you...

  • Deprivation of liberty by judicial or administrative decision
  • Adults 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rehabilitation Center Bouffard-Vercelli USSAP

Perpignan, France, 66000

Actively Recruiting

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Research Team

C

Charles FATTAL Charles FATTAL, MD, PhD

CONTACT

D

David GUIRAUD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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