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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
3
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.
Barrow Neurological Institute
Phoenix, Arizona, United States
Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant.
Time frame: 3-months following first use of the assistive device
Rate of Device-Related Adverse Events (AE)
Time frame: Up to 72 months after enrollment
Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: From enrollment, every 3 months, up to 72 months
Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score
Time frame: From enrollment, every 3 months, up to 72 months
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