Recruiting

Digital Assessment Interface

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT07407725

Conditions

Spinal Cord Injury

ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Eye Tracker

Mouth Operated Joystick

Non-invasive electroencephalogram (EEG) Headset

Implantable Brain-Computer-Interface

Personal Assistive Technology

Study Details

Brief summary:

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).

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.

Conditions

Spinal Cord Injury

ALS (Amyotrophic Lateral Sclerosis)

Study ID

NCT07407725

Start date

Jan 8, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: AT/BCI User

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.

Interventions

Eye Tracker

The intervention consists of two 40-minute training sessions using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The first session includes an orientation to the eye-tracking device, calibration, and setup adjustments, after which the clinician will confirm feasibility. Training begins with a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Participants are encouraged to complete all levels and focus on challenging primitives. In-clinic and at-home sessions are scheduled on separate days, with a rest period for in-clinic visits, ensuring adequate rest and retention of learned skills.

Mouth Operated Joystick

The intervention consists of two 40-minute training sessions using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The first session includes an orientation to the mouth-operated joystick device, calibration, and setup adjustments, after which the clinician will confirm feasibility. Training begins with a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Participants are encouraged to complete all levels and focus on challenging primitives. In-clinic and at-home sessions are scheduled on separate days, with a rest period for in-clinic visits, ensuring adequate rest and retention of learned skills.

Non-invasive electroencephalogram (EEG) Headset

The intervention consists of two 40-minute training sessions using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The first session includes an orientation to the non-invasive EEG headset device, calibration, and setup adjustments, after which the clinician will confirm feasibility. Training begins with a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Participants are encouraged to complete all levels and focus on challenging primitives. In-clinic and at-home sessions are scheduled on separate days, with a rest period for in-clinic visits, ensuring adequate rest and retention of learned skills.

Implantable Brain-Computer-Interface

Participants with an invasive Brain Computer Interface (BCI) implant, primarily recruited via Neuralink, will use the Neuralink N1 or any other implanted BCI. The intervention consists of one 40-minute training session using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The session begins with setup assistance and calibration to ensure proper positioning. Training includes a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Participants are encouraged to complete all levels and focus on the most challenging primitives. Prior experience with the device justifies the single-session design.

Personal Assistive Technology

Participants already using a personal assistive technology device will complete one 40-minute training session with a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The session begins with setup assistance and positioning. Training includes a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Participants are encouraged to complete all levels and focus on the most challenging primitives. Since the device is already familiar, only a single session is required.

Voice Control

The intervention consists of two 40-minute training sessions using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The first session includes an orientation to voice control, after which the clinician will confirm feasibility. Training begins with a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Participants are encouraged to complete all levels and focus on challenging primitives. In-clinic and at-home sessions are scheduled on separate days, with a rest period for in-clinic visits, ensuring adequate rest and retention of learned skills.

Primary outcome measure

  • Performance Outcomes (PerfOs) [ Time Frame: Through study completion, every visit during the Digital Assessment Interface. ]
  • Demographics and Medical Intake Questionnaire [ Time Frame: Day 1 ]
  • NASA Task Load Index [ Time Frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface. ]
  • NASA Task Load Index - Clinician's perspective [ Time Frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface. ]
  • System Usability Scale (SUS) [ Time Frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface. ]
  • System Usability Scale (SUS) - Clinician's perspective [ Time Frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface. ]
  • Qualitative Questionnaire [ Time Frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface. ]
  • Psychosocial Impact of Assistive Devices (PIAD) [ Time Frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface ]

Central Contacts and Locations

Central contacts

Arun Jayaraman, PT, PhD

312-238-6875ajayaraman@sralab.org

Richa Rai, PhD

312-238-6538rrai@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Richa Rai, PhD

312-238-6538rrai@sralab.org

Sara Prokup, PT, DPT

312-238-1355sprokup@sralab.org

Principal Investigator:

Arun Jayaraman, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • iBCI
  • Brain Computer Interface
  • Assistive Technology
  • Clinical Outcome Assessment
  • dADL
  • digital activities of daily living

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-05-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.