Portable control systems to operate a hand motor neuroprosthesis for people with tetraplegia
Evaluation of Non-invasive Control Interfaces for Operating Assistive Devices for Tetraplegic Individuals
The study will test whether several fully portable, non‑invasive control methods (for example shoulder‑motion IMUs, surface EMG, touch/contact sensors, and voice) let adults with tetraplegia reliably control a hand motor neuroprosthesis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Bouffard Vercelli - USSAP Academic / other |
| Locations | 1 site (Perpignan) |
| Trial ID | NCT07058506 on ClinicalTrials.gov |
What this trial studies
This interventional study compares multiple non‑invasive control interfaces that capture user intent to operate a motor neuroprosthesis delivering neural electrical stimulation for hand grasp. Participants will use each portable interface to control a software demonstration of a motor action while investigators measure reliability and precision of control. The work builds on prior demonstrations that neural stimulation can produce clinically useful grasping movements, but focuses on validating compact, wearable interfaces intended for integration with a future implanted stimulator. Eligible participants perform standardized tasks at the Perpignan rehabilitation center to generate comparable performance metrics across interfaces.
Who should consider this trial
Good fit: Adults aged 18–80 with a cervical spinal cord injury (AIS A, B, or C), neurologically stable for at least 3 months, who can follow instructions and attend testing sessions are the intended participants.
Not a fit: People with unstable neurologic status, cognitive impairment or legal restrictions on consent, those deprived of liberty, or those without the required social security coverage may not be eligible or likely to benefit.
Why it matters
Potential benefit: If successful, these portable control interfaces could provide people with tetraplegia a practical way to trigger reliable grasping with a hand neuroprosthesis and improve daily independence.
How similar studies have performed: Previous clinical work has shown feasibility of neurostimulation‑induced grasping using external shoulder sensors, myoelectric signals, and implanted stimulators, but direct comparisons of multiple portable non‑invasive interfaces are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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 this trial is running
Perpignan
- Rehabilitation Center Bouffard-Vercelli USSAP — Perpignan, France (Recruiting)
Study contacts
- Principal investigator: Charles FATTAL, MD, PhD — Centre Bouffard Vercelli - USSAP
- Study coordinator: Charles FATTAL Charles FATTAL, MD, PhD
- Email: cfattal@ussap.fr
- Phone: +33 430441100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.