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NCT Number: NCT07407725

Clinical Outcome Assessment for AT & BCI

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.

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Key information

Conditions

Spinal Cord Injury ALS (Amyotrophic Lateral Sclerosis) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases Spinal Cord Injuries TDP-43 Proteinopathies Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eye Tracker

Device

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

Mouth Operated Joystick

Device

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+

Non-invasive electroencephalogram (EEG) Headset

Device

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

Implantable Brain-Computer-Interface

Device

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

Personal Assistive Technology

Device

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

Device

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 outcomes

  1. Performance Outcomes (PerfOs)

    Time frame: 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.

  2. Demographics and Medical Intake Questionnaire

    Time frame: Day 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).

  3. NASA Task Load Index

    Time frame: Through 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).

  4. NASA Task Load Index - Clinician's perspective

    Time frame: Through 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).

  5. System Usability Scale (SUS)

    Time frame: 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).

  6. System Usability Scale (SUS) - Clinician's perspective

    Time frame: 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 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).

  7. Qualitative Questionnaire

    Time frame: Through 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).

  8. Psychosocial Impact of Assistive Devices (PIAD)

    Time frame: 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).

Secondary outcomes

  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

    Time frame: Day 1

    Classification of motor and sensory impairments that result from a spinal cord injury. This study involves an abbreviated version of the ISNCSCI in the medical intake questionnaire to include C1-T1 sensation, upper extremity and lower extremity motor scores, and a sacral sparing gathered through a short questionnaire. These scores will be translated into a modified ASIA (American Spinal Injury Association Impairment Scale) score for use in the characterization of AT/BCI systems (secondary objective).

  2. Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)

    Time frame: Day 1

    This scale, as part of the medical intake questionnaire, measures activities of daily living and global function for patients with ALS. The ALSFRS-R provides an estimate of a patient's degree of functional impairment, which can be evaluated serially to objectively assess any response to treatment or progression of disease. This will be utilized in the characterization of the Assistive Technology/Brain Computer Interface systems (secondary objective).

  3. Clinical Evaluation

    Time frame: Day 1

    Components of the clinical evaluation, such as comfort level with an Assistive Technology device and the use and experience with other Assistive Technology devices will be factored into the characterization of the Assistive Technology/Brain Computer Interface systems (secondary objective).

  4. Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Section GG

    Time frame: Day 1

    Standardized evaluation of functional abilities and goals related to self-care and mobility. This assessment provides detailed item-level information on patient function, using a 6-point scale to rate the level of assistance required for various activities, and will be used in the validation of the index and in the characterization of the Assistive Technology/Brain Computer Interface systems (secondary objectives).

  5. Edinburgh Cognitive and Behavioral ALS Screen (ECAS)

    Time frame: Day 1

    Comprehensive screening tool for cognitive and behavioral changes in individuals with amyotrophic lateral sclerosis, which will enable the study team to screen for cognitive changes that may impact study participation and inform Assistive Technology/Brain Computer Interface characterization (secondary objective).

  6. World Health Organization Quality of Life-BREF (WHOQOL-BREF)

    Time frame: Day 1

    Self-report questionnaire that addresses 4 quality of life domains: physical health, psychological health, social relationships, and environment. 2 other items measure overall quality of life and general health. This patient-reported outcome will be used in the validation of the index and in the characterization of the Assistive Technology/Brain Computer Interface systems (secondary objectives).

Study contacts

Contact information is provided by the study sponsor or research team.

Arun Jayaraman, PT, PhD

CONTACT

[email protected]

312-238-6875

Richa Rai, PhD

CONTACT

[email protected]

312-238-6538

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Neuralink Corp

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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