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Measuring Computer Independence With Assistive Technology in Spinal Cord Injury and ALS

Develops a score for how well assistive devices help people operate computers.

Key facts

Who runs it
Shirley Ryan AbilityLab
Where
Chicago, United StatesSee the site
Trial code
Registry title
Clinical Outcome Assessment for AT & BCI
Status
Recruiting
People taking part
60 people, planned
Started
8 Jan 2026
Expected to end
Jun 2027
Type of study
Interventional
Treatments tested
  • Eye Tracker
  • Mouth Operated Joystick
  • Non-invasive electroencephalogram (EEG) Headset
  • Implantable Brain-Computer-Interface
  • Personal Assistive Technology
  • Voice Control
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with spinal cord injury or ALS, with or without an implanted brain-computer interface, and healthy adults. They test computer tasks with assistive tools.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Spinal cord injury at level T1 or above (between C1 and T1), or a diagnosis of amyotrophic lateral sclerosis (ALS). Healthy controls need no history of neurological or psychiatric disorders.
Earlier treatment
Some ALS or spinal cord injury participants have had an invasive brain-computer interface implanted. Others have no implanted device.

Main reasons for not taking part

  • Taking part in another trial that would conflict with this study
  • Healthy controls: hearing, vision or thinking problems that would interfere with the study
  • Healthy controls: a current or past condition that could confound the assessments
  • Cannot take part in a study session of about 3 hours (breaks allowed)

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • Age at or above 18 years old
  • Diagnosis of spinal cord injury, at the level of T1 or above levels (between C1 and T1)
  • Ability to communicate independently or with a support device, or with a legal representative
  • Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed
  • Age at or above 18 years old
  • Diagnosis of amyotrophic lateral sclerosis
  • Ability to communicate independently, with a support device, or with a legal representative
  • Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed
  • Age at or above 18 years old
  • No history of neurological or psychiatric disorders
  • Ability to provide written informed consent
  • Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed

Who cannot take part

  • Current or prior diagnosis or condition that could confound study assessments
  • Participation in another trial that would conflict with the current study or clinical endpoint interference may occur; Amyotrophic Lateral Sclerosis (ALS):
  • ● Participation in another trial that would conflict with the current study or clinical endpoint interference may occur
  • Healthy Controls:
  • Participation in another trial that would conflict with the current study or clinical endpoint interference may occur
  • Cognitive, visual, or auditory deficits that would interfere with study participation

Other criteria

  • Enrollment will involve three different cohorts, namely a cohort of healthy participant, a cohort of ALS/SCI participant who underwent the implant of an invasive BCI device, and a cohort of ALS/SCI participants without any implanted BCI device
  • Below are listed the inclusion and exclusion criteria for each diagnostic group
  • Spinal Cord Injury (SCI):

Where in United States

  • Shirley Ryan AbilityLabChicago, United StatesContact: Richa Rai, PhDTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The group in the trial

  • AT/BCI UserTreatment being tested

    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.

    Treatment: Eye Tracker, Mouth Operated Joystick, Non-invasive electroencephalogram (EEG) Headset, Implantable Brain-Computer-Interface, Personal Assistive Technology, and Voice Control

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Development of a Clinical Outcome Assessment for Assistive Technologies and Brain-Computer-Interfaces
Plain-language title
Measuring Computer Independence With Assistive Technology in Spinal Cord Injury and ALSGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 November 2026