Clinical Outcome Assessment for AT & BCI

NCT07407725 | Recruiting

• 1 other identifier: STU00224714
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Performance Outcomes (PerfOs)

  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.

  Through study completion, every visit during the Digital Assessment Interface.

• Demographics and Medical Intake Questionnaire

  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).

  Day 1

• NASA Task Load Index

  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).

  Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.

• NASA Task Load Index - Clinician's perspective

  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).

  Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.

• System Usability Scale (SUS)

  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).

  Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.

• System Usability Scale (SUS) - Clinician's perspective

  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).

  Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.

• Qualitative Questionnaire

  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).

  Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.

• Psychosocial Impact of Assistive Devices (PIAD)

  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).

  Through study completion, every visit after an attempt or completion of the Digital Assessment Interface

Secondary Outcomes (6)

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

  Day 1

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

  Day 1

• Clinical Evaluation

  Day 1

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

  Day 1

• Edinburgh Cognitive and Behavioral ALS Screen (ECAS)

  Day 1

Study Arms (1)

AT/BCI User

EXPERIMENTAL

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; Device: Mouth Operated Joystick; Device: Non-invasive electroencephalogram (EEG) Headset; Device: Implantable Brain-Computer-Interface; Device: Personal Assistive Technology; Device: Voice Control

Interventions

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.

Also known as: Tobii Dynavox PCEye 5

AT/BCI User

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.

Also known as: Jouse+

AT/BCI User

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.

Also known as: EMOTIVE EPOC X

AT/BCI User

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.

Also known as: Neuralink N1 Implant

AT/BCI User

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.

AT/BCI User

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.

AT/BCI User

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Spinal Cord Injury (SCI):
• 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.
• Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
• Amyotrophic Lateral Sclerosis (ALS):
• 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.
• ● Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
• Healthy Controls:
• Age at or above 18 years old;
• No history of neurological or psychiatric disorders;

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Neuralink Corp: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (23)

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  BACKGROUND

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  BACKGROUND

• Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4. No abstract available.

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  BACKGROUND

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Related Links

• WHO- Global report on assistive technology
• CMS- IRF-PAI Section GG

MeSH Terms

Conditions

Spinal Cord Injuries; Amyotrophic Lateral Sclerosis

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Arun Jayaraman, PT, PhD

CONTACT

312-238-6875; ajayaraman@sralab.org

Richa Rai, PhD

CONTACT

312-238-6538; rrai@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 12, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)