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NCT07407725

Clinical Outcome Assessment for AT & BCI

Recruiting
NAAges 18+InterventionalSupportive care
Shirley Ryan AbilityLab
~60 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Eye TrackerMouth Operated JoystickNon-invasive electroencephalogram (EEG) HeadsetImplantable Brain-Computer-InterfacePersonal Assistive TechnologyVoice Control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance Outcomes (PerfOs)
Measured over Through study completion, every visit during the Digital Assessment Interface.
+7 more outcomes measured

Conditions

Spinal Cord Injury
ALS (Amyotrophic Lateral Sclerosis)

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Arun Jayaraman, PT, PhD
[email protected]
312-238-6875
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Eligibility criteria

Inclusion

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.
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.
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

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

What this trial measures

  • Performance Outcomes (PerfOs)Through study completion, every visit during the Digital Assessment Interface.

    Quantitative metrics will be extracted from a customized Digital Assessment Interface simulating digital activities of daily living (dADLs, e.g., online shopping, texting, gaming, booking appointments). Metrics will be collected for each motor primitive (clicking, scrolling, typing, click-and-drag) to evaluate performance, including click accuracy, time to target, number of errors, cursor trajectory, words per minute, and percentage of correct letters/characters.

  • Demographics and Medical Intake QuestionnaireDay 1

    Demographic characteristics such as age and sex will be considered for index development (primary objective), along with level of education and race/ethnicity for index validation and characterization of Assistive Technology/Brain Computer Interface systems (secondary objective). Medical intake information, including diagnosis, will be considered for index development (primary), validation (secondary), and device characterization (secondary).

  • NASA Task Load IndexThrough study completion, every visit after an attempt or completion of the Digital Assessment Interface.

    A self-report questionnaire for measuring the perceived workload of the use of each assistive technology across 6 domains: mental demand, physical demand, temporal demand, performance, effort, and frustration. This will be conducted to inform index development (primary objective) as well as validation and device characterization (secondary objectives).

  • NASA Task Load Index - Clinician's perspectiveThrough study completion, every visit after an attempt or completion of the Digital Assessment Interface.

    A self-report questionnaire for measuring the perceived workload of the use of each assistive technology across 6 domains: mental demand, physical demand, temporal demand, performance, effort, and frustration. This will be conducted as a clinician-reported outcome, where the clinician will evaluate the participant's level of fatigue in performing digital activities of daily living. This measure will be used to inform index development (primary objective) as well as validation and device characterization (secondary objectives).

  • System Usability Scale (SUS)Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.

    A brief 10-item questionnaire that measures a system's overall perceived usability. Items are rated on a 5-point Likert scale to measure ease of use, complexity, and user experience. This will be conducted as an outcome measure for index development (primary objective) as well as validation and device characterization (secondary objectives).

  • System Usability Scale (SUS) - Clinician's perspectiveThrough study completion, every visit after an attempt or completion of the Digital Assessment Interface.

    A brief 10-item questionnaire that measures a system's overall perceived usability. Items are rated on a 5-point Likert scale to measure ease of use, complexity, and user experience. This will be conducted as a clinician-reported outcome, where the clinician will evaluate the participant's usability of the experimental device in performing digital activities of daily living. This measure will be used to inform index development (primary objective) as well as validation and device characterization (secondary objectives).

  • Qualitative QuestionnaireThrough study completion, every visit after an attempt or completion of the Digital Assessment Interface.

    Modified version of the Canadian Occupational Performance Measure (COPM) to better capture functional digital independence. The qualitative questionnaire is conducted via a semi-structured interview to help participants identify goals in the area of digital independence and rate their performance and satisfaction on a scale. This measure will be used to inform index development (primary objective) as well as validation and device characterization (secondary objectives).

  • Psychosocial Impact of Assistive Devices (PIAD)Through study completion, every visit after an attempt or completion of the Digital Assessment Interface

    Self-report questionnaire designed to measure the effects of an assistive device on functional independence, well-being, and quality of life. It is a patient-reported outcome measure that assesses perceptions of competence, adaptability, and self-esteem, helping to understand the user's experience and predict device adoption/abandonment. This measure will be used to inform index development (primary objective) as well as validation and device characterization (secondary objectives).