Measuring how assistive technologies and brain-computer interfaces help people use digital devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a simulated set of online and digital tasks that reflect important daily digital activities and asks participants to complete them using a range of assistive technologies and BCIs. Participants will include healthy volunteers, people with ALS or spinal cord injury who have an implanted invasive BCI, and people with ALS or spinal cord injury without implants. Devices tested include eye trackers, mouth-operated joysticks, non-invasive EEG headsets, implantable BCIs, and personal assistive technology, and results will be combined into a standardized Digital Assessment Interface score. The goal is to create an objective index of digital independence that can be used to compare and interpret functional benefit across tools.

Why it matters

Who can join: the full rules

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):

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.

Amyotrophic Lateral Sclerosis (ALS):

Inclusion criteria:

* 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.

Exclusion criteria:

● Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.

Healthy Controls:

Inclusion criteria:

* 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.

Exclusion criteria:

* 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;
* Current or prior diagnosis or condition that could confound study assessments.

Where it's running

• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Arun Jayaraman, PT, PhD
• Email: ajayaraman@sralab.org
• Phone: 312-238-6875

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.