Control of Assistive Devices Via Brain-Computer Interface Technology

Launched by NEURALINK CORP · Nov 26, 2024

Keywords

ClinConnect Summary

The CONVOY study is a small, early feasibility trial to see if people who already have Neuralink’s N1 brain implant can learn to control assistive devices—primarily an Assistive Robotic Arm—using their brain signals. It is a single-arm, open-label study, meaning everyone receives the same intervention and there’s no comparison group. The study plans to enroll about 3 participants of any sex and age group (children, adults, and older adults) who are still enrolled in the PRIME study and have their N1 implant in place. People who have the implant removed, who haven’t shown enough brain-control ability, or who have safety concerns preventing participation would not be eligible.

Participants will be trained to use the N1 implant to steer the robotic arm and possibly other devices. The main question is whether they can reliably modulate brain activity to control the device within about 3 months of first use. Safety is also watched closely: researchers will track device-related adverse events for up to about 72 months. They will also measure quality of life and how attitudes toward assistive devices change every few months, for up to 72 months. The trial is sponsored by Neuralink and taking place at Barrow Neurological Institute in Phoenix, Arizona. This is a device study, and results are not yet available. Enrollment is by invitation and ongoing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Continued enrollment in the PRIME Study.
• • Implanted with the N1 Implant.
• Exclusion Criteria:
• • Explantation or deactivation of the N1 Implant.
• • Insufficient N1 Implant BCI performance demonstrated.
• • Lack of a suitable physical space to perform research sessions.
• • Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.