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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Crossover Assignment
Intervention Model Description
Participants will complete the assessment with up to four different devices, and any existing device or iBCI they use in their daily life. It is a randomized, within-subject crossover interventional study in which participants complete standardized digital tasks using multiple assistive technologies in randomized order. There is one arm per technology within each participant.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: 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.
    Other names:
    • Tobii Dynavox PCEye 5
  • Device: 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.
    Other names:
    • Jouse+
  • Device: 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.
    Other names:
    • EMOTIVE EPOC X
  • Device: 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.
    Other names:
    • Neuralink N1 Implant
  • Device: 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.

Recruiting Locations

Shirley Ryan AbilityLab
Chicago 4887398, Illinois 4896861 60611
Contact:
Richa Rai, PhD
312-238-6538
rrai@sralab.org

More Details

Status
Recruiting
Sponsor
Shirley Ryan AbilityLab

Study Contact

Arun Jayaraman, PT, PhD
312-238-6875
ajayaraman@sralab.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.