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Enrolling by invitation NCT06710626

Control of Assistive Devices Via Brain-Computer Interface Technology

No phase Interventional Tetraplegia/Tetraparesis Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Spinal Cord Injury (SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assistive Robotic Arm.
Who it may be relevant to
Registry conditions: Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS), Quadriplegia, Spinal Cord Injury (SCI). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CONVOY: An Early Feasibility Study of Neural Control of Assistive Devices Via Brain-Computer Interface Technology

Overview

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

  • Device Assistive 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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Barrow Neurological Institute — Phoenix

Identifiers

NCT: NCT06710626 · N1-EFS-100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗