Amyotrophic Lateral Sclerosis (ALS), Quadriplegia, Spinal Cord Injury Cervical, Spinal Cord Injury (SCI), Tetraplegia/Tetraparesis
Conditions
Keywords
brain computer interface, robotic arm, assistive device, Neuralink N1 Implant, Neuralink, N1 Implant, ALS, Spinal cord injury, Quadriplegia, tetraplegia, Robot, external device control, neuroprosthetics
Brief summary
The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.
Interventions
DEVICEAssistive Robotic Arm
The intervention involves using the N1 Implant, a wireless brain-computer interface (BCI), to enable participants to control the Assistive Robotic Arm through neural signals.
Sponsors
Neuralink Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant. | 3-months following first use of the assistive device |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Device-Related Adverse Events (AE) | Up to 72 months after enrollment |
| Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS) | From enrollment, every 3 months, up to 72 months |
| Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score | From enrollment, every 3 months, up to 72 months |
Countries
United States
Outcome results
None listed