Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07407725

Development of a Clinical Outcome Assessment for Assistive Technologies and Brain-Computer-Interfaces

Led by Shirley Ryan AbilityLab · Updated on 2026-05-05

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

Shirley Ryan AbilityLab

Lead Sponsor

N

Neuralink Corp

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new way to measure how assistive technologies (ATs) and brain-computer interfaces (BCIs) help people with severe motor impairments operate digital devices like computers and phones. This study aims to create a standardized Digital Assessment Interface (DAI) that simulates important online and digital tasks. The goal is to develop an index that combines performance, clinician-reported, and patient-reported outcomes to compare and quantify the real-world benefits of different ATs and BCIs across various user groups, including those with spinal cord injury (SCI), amyotrophic lateral sclerosis (ALS), and healthy individuals. Participants will use several assistive devices, including eye trackers, mouth-operated joysticks, non-invasive EEG headsets, implantable BCIs, voice control systems, and their personal assistive technologies. Training sessions involve practicing digital tasks such as clicking, typing, scrolling, and drawing through a customized Digital Training Interface. The study includes multiple sessions both in-clinic and at home, with rest periods to ensure comfort and skill retention. Participants experience the devices in a randomized order to assess their functional performance comprehensively. During the study, participants will complete various assessments including performance outcomes on the DAI, questionnaires on task load and system usability from both participant and clinician perspectives, and psychosocial impact surveys. Additional evaluations include neurological classifications, functional rating scales, cognitive assessments, and quality of life measures. These outcomes will be measured at every visit through study completion. The involvement typically lasts about three hours per session, with breaks as needed, and the study will continue until June 2027, aiming to ensure reliable and valid measurement of digital independence for users of assistive technologies and BCIs.

CONDITIONS

Brief Title

Clinical Outcome Assessment for AT & BCI

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at or above 18 years old
  • Diagnosis of spinal cord injury at the level of T1 or above (between C1 and T1)
  • Ability to communicate independently, with a support device, or with a legal representative
  • Ability to participate in a study session for about 3 hours, including breaks as needed
  • Diagnosis of amyotrophic lateral sclerosis (ALS)
  • No history of neurological or psychiatric disorders for healthy controls
  • Ability to provide written informed consent for healthy controls
Not Eligible

You will not qualify if you...

  • Participation in another trial that conflicts with this study or may interfere with clinical endpoints
  • Cognitive, visual, or auditory deficits that interfere with study participation for healthy controls
  • Any current or prior diagnosis or condition that could confound study assessments for healthy controls
  • Other conflicts that would prevent proper participation or affect data validity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Several days depending on device training schedule

Participants receive training sessions using various assistive technology and brain-computer interface devices. Training includes orientation, calibration, and guided tutorials with practice levels to improve digital activity control. Sessions occur both in-clinic and at home on separate days, with rest periods to ensure skill retention. Some devices require two 40-minute sessions, while familiar devices or implanted BCI require one 40-minute session.

Multiple visits including in-clinic and at-home sessions

Monitoring

Duration - Up to study completion (approximately 1 to 2 years)

Throughout the trial, participants complete performance assessments and questionnaires after each device training session to evaluate usability, task load, and psychosocial impact.

Visits after each training session for assessments

Trial Site Locations

Total: 1 location

1

Shirley Ryan AbilityLab

Chicago, Illinois, United States, 60611

Actively Recruiting

Loading map...

Research Team

A

Arun Jayaraman, PT, PhD

R

Richa Rai, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

Similar Trials

A Neuroprosthesis for Seated Posture and Balance

Spinal Cord Injury

Actively Recruiting

1 location

A Multiple Ascending Dose Phase 1 Study to Assess the Safety...

ALS (Amyotrophic Lateral Sclerosis)

Actively Recruiting

12 locations

Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord...

Spinal Cord Injury Cervical

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

A clinical prediction rule for ambulation outcomes after traumatic spinal cord injury: a longitudinal cohort study.

Joost J van Middendorp, Allard J F Hosman, A Rogier T Donders...

https://pubmed.ncbi.nlm.nih.gov/21377202