Assistive Technologies for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers. Clinicians and researchers currently lack a common framework to objectively quantify how much a given AT or BCI improves real-world function or to compare across tools. This project seeks to address this gap by developing a standardized method to objectively assess or compare the functional benefit of these tools on digital independence, i.e., the ability to independently operate computers, phones, and other digital systems, by creating a unique Digital Assessment Interface (DAI).
This assessment will be a simulation of online and digital activities that prior work has determined is important to functional daily living in the digital domain. Participants will complete this assessment with various ATs and BCIs, and these scores will be used to create an index, which will be comprised of performance outcomes, clinician-reported outcomes, and patient-reported outcomes.
The tool aims to quantify and compare digital task performance across devices and user populations. The primary objective of this study is to develop an index. The index will quantify functional performance of individuals using various ATs and BCIs. The secondary objectives are to extensively evaluate the psychometric properties of the index, such as the validity, responsiveness, reliability, and floor/ceiling effects both globally and across different devices and impairment levels, ensuring that it can reliably measure the impact of an AT or BCI on a user's ability to independently operate digital systems; and to characterize the familiarization and use of specific BCI and AT systems with reference to a normative healthy control population.
Are You a Good Fit for This Trial?
This trial is for individuals with severe motor impairments due to conditions like spinal cord injury or ALS, also known as Lou Gehrig's Disease. Participants should be reliant on assistive technologies or brain-computer interfaces for digital device interaction.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Training and Assessment
Participants undergo training and complete digital assessments using various assistive technologies and brain-computer interfaces
Follow-up
Participants are monitored for safety and effectiveness after the assessment phase
What Are the Treatments Tested in This Trial?
Interventions
- Digital Assessment Interface (DAI)
Trial Overview
The study is testing various assistive tools including mouth-operated joysticks, eye trackers, personal tech, implantable BCIs, and EEG headsets. The goal is to develop a standardized method to assess these tools' impact on users' digital independence.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, non-invasive electroencephalogram (EEG) headset), brain-computer-interfaces, and applicable personal ATs. Participants will experience each of these devices in a randomized order. Participants in this arm will include individuals with a diagnosis of amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), or healthy individuals.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shirley Ryan AbilityLab
Lead Sponsor
Neuralink Corp
Industry Sponsor
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