Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
About this trial
This feasibility and safety trial is enrolling 2 participants with impaired speech and severe upper-limb impairment, e.g. due to cervical spinal cord injury, to test the safety of the Connexus Brain-Computer Interface (BCI). BCI is a technique using a computer and connected electrodes on the brain surface to record brain activity and to use that activity to control an external devise or assistive communication system. If included, participants will undergo implantation and evaluation of the BCI system. Final testing of device safety will be performed up to 6 years after implantation.
Included participants
What’s involved
Type
Details
- Participants will undergo implantation and evaluation of the Connexus Brain-Computer Interface (BCI) and complete functional assessments related to communication (speech) and computer control performance. - BCI is a technique using a computer and connected electrodes on the brain to record brain activity and to use that activity to control an external device. - Final testing of device safety and effectiveness will be performed after 6 years.
Potential benefits
Main benefits
General health
Additional benefits
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Recruiting
- Trial start date
- 1 Jan 2026
- Organisation
- Paradromics
- Trial recruitment status
- Recruiting
- Trial start date
- 1 Jan 2026
- Organisation
- Paradromics
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more