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

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

This project will test a Digital Assessment Interface to see if it can measure how well different assistive technologies and brain-computer interfaces help adults with spinal cord injury or ALS use computers, phones, and other digital systems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shirley Ryan AbilityLab (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07407725 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with spinal cord injury at C1–T1 or with ALS who can communicate (directly or with assistance), can tolerate approximately 3-hour sessions, and who fit the implant or non-implant cohort criteria are ideal candidates.

Not a fit: People without ALS or spinal cord injury, those with severe cognitive impairment or inability to communicate or tolerate study sessions, or those enrolled in conflicting trials are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this could give clinicians and people with motor impairments a standard score to compare devices and choose the technology that best improves digital independence.

How similar studies have performed: Prior work has shown that BCIs and assistive technologies can restore communication and control for some people, but a standardized digital assessment index to compare these tools is novel and has limited prior validation.

Eligibility 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):

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 this trial is running

Chicago, Illinois

• Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Arun Jayaraman, PT, PhD

Conditions Spinal Cord Injury; ALS; iBCI; Brain Computer Interface; Assistive Technology; Clinical Outcome Assessment; dADL; digital activities of daily living