Assistive Technologies for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to develop a new tool to measure how well assistive technologies (ATs) and brain-computer interfaces (BCIs) help people with severe motor impairments use digital devices independently. Participants will test various devices, such as eye trackers and mouth-operated joysticks, to assess their effectiveness in performing digital tasks. The study will focus on individuals with amyotrophic lateral sclerosis (ALS) or spinal cord injuries (SCI) who can communicate and participate in a study session for up to three hours. Researchers will use the Digital Assessment Interface (DAI) to evaluate these technologies. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance digital independence for individuals with severe motor impairments.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It only mentions that participation in another conflicting trial is not allowed.
What prior data suggests that these assistive technologies and brain-computer interfaces are safe for users?
Research has shown that assistive technologies (ATs) and brain-computer interfaces (BCIs) are generally well-tolerated by people with severe movement difficulties. A review of ATs indicates that these tools are safe and helpful for those with neurological disabilities. Common tools like eye trackers and mouth-operated joysticks assist users in communicating and interacting with digital devices. Studies have found these tools to be safe and free from major side effects.
For brain-computer interfaces, research on non-invasive options like EEG headsets (which monitor brain activity) has shown they are safe. People using these devices have not reported serious negative effects. Individuals with conditions like ALS (amyotrophic lateral sclerosis) often use them to aid communication.
Since the Digital Assessment Interface (DAI) uses these types of technologies, the safety evidence from these studies suggests it should be well-tolerated. Overall, the tools tested in this trial have a strong safety record.12345Why are researchers excited about this trial?
Researchers are excited about the Digital Assessment Interface (DAI) for ALS because it integrates advanced assistive technologies like eye trackers, mouth-operated joysticks, and non-invasive EEG headsets. Unlike traditional methods that focus on symptom management, DAI aims to enhance communication and interaction for individuals with ALS by using brain-computer interfaces that can better adapt to each user's needs. This personalized approach could significantly improve the quality of life for patients by allowing more intuitive control over their environment.
What evidence suggests that this Digital Assessment Interface is effective for improving digital independence in ALS?
Research has shown that assistive technologies (ATs) and brain-computer interfaces (BCIs) can help people with ALS (a disease that weakens muscles) use digital devices more independently. In this trial, participants in the AT/BCI User arm will undergo training and digital assessment using various assistive technologies, including eye trackers, mouth-operated joysticks, and non-invasive EEG headsets. Eye-tracking devices, for example, enable individuals with limited movement to control computers by moving their eyes. Studies have found that BCIs, which read brain signals, can also help users manage digital systems effectively. Direct comparisons of eye trackers and BCIs show promise in assisting ALS patients. Overall, these technologies can ease the use of digital devices for people with severe movement difficulties.16789
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?
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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
Citations
Clinical Outcome Assessment for AT & BCI
Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, ...
New technologies and Amyotrophic Lateral Sclerosis
The present work reviews the current technologies for ALS patients already in place or being under evaluation with published publications, ...
A Comparison of a Brain-Computer Interface and an Eye ...
A comparative study between both technologies in an ALS patient is carried out: an eye tracker and a visual P300-based BCI. The purpose of the ...
4.
napier-repository.worktribe.com
napier-repository.worktribe.com/preview/2858270/Eye-Tracking_Assistive_Technologies_for_Individuals_With_Amyotrophic_Lateral_Sclerosis.pdfEye-Tracking Assistive Technologies for Individuals With ...
For individuals with. ALS, where mobility is limited to the movement of the eyes, the use of eye-tracking-based applications can be applied to achieve some ...
A Comparison of a Brain-Computer Interface and an Eye ...
A comparative study between both technologies in an ALS patient is carried out: an eye tracker and a visual P300-based BCI. The purpose of the study presented ...
Assistive Technologies for Individuals with a Disability ... - PMC
This narrative review aims to explore the integration, benefits, and challenges of assistive technologies in individuals with neurological disabilities.
7.
researchgate.net
researchgate.net/publication/395969525_Eye-Tracking_and_BCI_Integration_for_Assistive_Communication_in_Locked-In_Syndrome_Pilot_Study_with_Healthy_Participants(PDF) Eye-Tracking and BCI Integration for Assistive ...
Eye-tracking (ET) systems are common communication tools in early LIS but become ineffective as oculomotor function declines. EEG-based Brain- ...
Fully Implanted Brain–Computer Interface in a Locked ...
We report on a communication system that involves a totally implantable brain–computer interface for home use by a locked-in patient with ALS.
Supporting effective alternative access for individuals with ...
Our review of the literature revealed a range of combinations of access solutions including technology such as eye tracking, head tracking, switches, joysticks, ...
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