Spinal Cord InjuryNCT07407725
Clinical Outcome Assessment for AT & BCI
A study testing Eye Tracker, Mouth Operated Joystick and Non-invasive electroencephalogram (EEG) Headset in people with Spinal Cord Injury and ALS (Amyotrophic Lateral Sclerosis), run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
- What is being tested?
- Eye Tracker, Mouth Operated Joystick and Non-invasive electroencephalogram (EEG) Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 12Show fewer
- 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.
Who cannot join
- Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
- Amyotrophic Lateral Sclerosis (ALS):
- ● Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
- Healthy Controls:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Richa Rai, PhD, 312-238-6538, rrai@sralab.org
Sara Prokup, PT, DPT, 312-238-1355, sprokup@sralab.org
About this study
Official title: Development of a Clinical Outcome Assessment for Assistive Technologies and Brain-Computer-Interfaces
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.
- Being tested
- Eye Tracker, Mouth Operated Joystick, Non-invasive electroencephalogram (EEG) Headset, Implantable Brain-Computer-Interface, Personal Assistive Technology
- Keywords
- iBCI, Brain Computer Interface, Assistive Technology, Clinical Outcome Assessment, dADL, digital activities of daily living
- Medical subject headings
- Spinal Cord Injuries, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye TrackerDevice
Also called Tobii Dynavox PCEye 5
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 JoystickDevice
Also called Jouse+
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) HeadsetDevice
Also called EMOTIVE EPOC X
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-InterfaceDevice
Also called Neuralink N1 Implant
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 TechnologyDevice
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 ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
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).
Measured: Day 1
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
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).
Measured: Day 1
Clinical Evaluation
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).
Measured: Day 1
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Section GG
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).
Measured: Day 1
Edinburgh Cognitive and Behavioral ALS Screen (ECAS)
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).
Measured: Day 1
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start8 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Neuralink Corp
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407725
- Sponsor's protocol ID
- STU00224714
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sawyer A, Brannigan J, Spielman L; BCI Functional Outcome Measures Group; Putrino D, Fry A. Development of a novel clinical outcome assessment: digital instrumental activities of daily living. EBioMedicine. 2025 Jun;116:105732. doi: 10.1016/j.ebiom.2025.105732. Epub 2025 May 26.
PubMed 40424668Consortium for Spinal Cord Medicine. Outcomes following traumatic spinal cord injury: clinical practice guidelines for health-care professionals. J Spinal Cord Med. 2000 Winter;23(4):289-316. doi: 10.1080/10790268.2000.11753539. No abstract available.
PubMed 17536300Anderson K, Aito S, Atkins M, Biering-Sorensen F, Charlifue S, Curt A, Ditunno J, Glass C, Marino R, Marshall R, Mulcahey MJ, Post M, Savic G, Scivoletto G, Catz A; Functional Recovery Outcome Measures Work Group. Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research. J Spinal Cord Med. 2008;31(2):133-44. doi: 10.1080/10790268.2008.11760704.
PubMed 18581660Pupillo E, Messina P, Giussani G, Logroscino G, Zoccolella S, Chio A, Calvo A, Corbo M, Lunetta C, Marin B, Mitchell D, Hardiman O, Rooney J, Stevic Z, Bandettini di Poggio M, Filosto M, Cotelli MS, Perini M, Riva N, Tremolizzo L, Vitelli E, Damiani D, Beghi E; EURALS Consortium. Physical activity and amyotrophic lateral sclerosis: a European population-based case-control study. Ann Neurol. 2014 May;75(5):708-16. doi: 10.1002/ana.24150. Epub 2014 May 21.
PubMed 24706338Turner MR, Hardiman O, Benatar M, Brooks BR, Chio A, de Carvalho M, Ince PG, Lin C, Miller RG, Mitsumoto H, Nicholson G, Ravits J, Shaw PJ, Swash M, Talbot K, Traynor BJ, Van den Berg LH, Veldink JH, Vucic S, Kiernan MC. Controversies and priorities in amyotrophic lateral sclerosis. Lancet Neurol. 2013 Mar;12(3):310-22. doi: 10.1016/S1474-4422(13)70036-X.
PubMed 23415570Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
PubMed 15672628van Middendorp JJ, Hosman AJ, Donders AR, Pouw MH, Ditunno JF Jr, Curt A, Geurts AC, Van de Meent H; EM-SCI Study Group. A clinical prediction rule for ambulation outcomes after traumatic spinal cord injury: a longitudinal cohort study. Lancet. 2011 Mar 19;377(9770):1004-10. doi: 10.1016/S0140-6736(10)62276-3. Epub 2011 Mar 4.
PubMed 21377202Fessler EB, Brown RT, Miller RK. Rebooting Instrumental Activities of Daily Living for the 21st Century. Ann Intern Med. 2022 Feb;175(2):278-279. doi: 10.7326/M21-3065. Epub 2021 Dec 21. No abstract available.
PubMed 34928697Lu X, Yao Y, Jin Y. Digital exclusion and functional dependence in older people: Findings from five longitudinal cohort studies. EClinicalMedicine. 2022 Oct 31;54:101708. doi: 10.1016/j.eclinm.2022.101708. eCollection 2022 Dec.
PubMed 36353265Mois G, Rogers WA. Developing a Framework for Digital Activities of Daily Living. Gerontologist. 2024 Oct 1;64(10):gnae110. doi: 10.1093/geront/gnae110.
PubMed 39163564Rigby P, Ryan SE, Campbell KA. Electronic aids to daily living and quality of life for persons with tetraplegia. Disabil Rehabil Assist Technol. 2011;6(3):260-7. doi: 10.3109/17483107.2010.522678. Epub 2010 Oct 1.
PubMed 20883120Fairman, A. D., Indradhirmaya, F. A., Osal, R. B. & Saptono, A. Iterative User-Centered Design of the Mobile Device Assessment Tool (MoDAT). Technologies 13, 358 (2025).
Dohle, E. et al. Outcome measures in implantable brain-computer interface research: a systematic review. 2024.10.15.24315534 Preprint at https://doi.org/10.1101/2024.10.15.24315534 (2024).
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.
PubMed 27815685Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21. doi: 10.1016/s0022-510x(99)00210-5.
PubMed 10540002
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Clinical Outcome Assessment for Assistive Technologies and Brain-Computer-Interfaces
- ClinicalTrials.gov ID
- NCT07407725
- Acronym / sponsor ID
- STU00224714
- Keywords
- iBCI, Brain Computer Interface, Assistive Technology, Clinical Outcome Assessment, dADL, digital activities of daily living
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Neuralink Corp
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| AT/BCI User | Experimental | Device: Eye Tracker, Device: Mouth Operated Joystick, Device: Non-invasive electroencephalogram (EEG) Headset, Device: Implantable Brain-Computer-Interface, Device: Personal Assistive Technology, Device: Voice ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye TrackerAlso: Tobii Dynavox PCEye 5The 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. | Device | AT/BCI User |
| Mouth Operated JoystickAlso: Jouse+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. | Device | AT/BCI User |
| Non-invasive electroencephalogram (EEG) HeadsetAlso: EMOTIVE EPOC XThe 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. | Device | AT/BCI User |
| Implantable Brain-Computer-InterfaceAlso: Neuralink N1 ImplantParticipants 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. | Device | AT/BCI User |
| Personal Assistive TechnologyParticipants 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. | Device | AT/BCI User |
| Voice ControlThe 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. | Device | AT/BCI User |
Primary outcome
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.
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).
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).
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).
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).
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).
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).
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).
6 secondary outcomes
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: Day 1
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Time frame: Day 1
Clinical Evaluation
Time frame: Day 1
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Section GG
Time frame: Day 1
Edinburgh Cognitive and Behavioral ALS Screen (ECAS)
Time frame: Day 1
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 40424668Sawyer A, Brannigan J, Spielman L; BCI Functional Outcome Measures Group; Putrino D, Fry A. Development of a novel clinical outcome assessment: digital instrumental activities of daily living. EBioMedicine. 2025 Jun;116:105732. doi: 10.1016/j.ebiom.2025.105732. Epub 2025 May 26.
- Background: PubMed 17536300Consortium for Spinal Cord Medicine. Outcomes following traumatic spinal cord injury: clinical practice guidelines for health-care professionals. J Spinal Cord Med. 2000 Winter;23(4):289-316. doi: 10.1080/10790268.2000.11753539. No abstract available.
- Background: PubMed 18581660Anderson K, Aito S, Atkins M, Biering-Sorensen F, Charlifue S, Curt A, Ditunno J, Glass C, Marino R, Marshall R, Mulcahey MJ, Post M, Savic G, Scivoletto G, Catz A; Functional Recovery Outcome Measures Work Group. Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research. J Spinal Cord Med. 2008;31(2):133-44. doi: 10.1080/10790268.2008.11760704.
- Background: PubMed 24706338Pupillo E, Messina P, Giussani G, Logroscino G, Zoccolella S, Chio A, Calvo A, Corbo M, Lunetta C, Marin B, Mitchell D, Hardiman O, Rooney J, Stevic Z, Bandettini di Poggio M, Filosto M, Cotelli MS, Perini M, Riva N, Tremolizzo L, Vitelli E, Damiani D, Beghi E; EURALS Consortium. Physical activity and amyotrophic lateral sclerosis: a European population-based case-control study. Ann Neurol. 2014 May;75(5):708-16. doi: 10.1002/ana.24150. Epub 2014 May 21.
- Background: PubMed 23415570Turner MR, Hardiman O, Benatar M, Brooks BR, Chio A, de Carvalho M, Ince PG, Lin C, Miller RG, Mitsumoto H, Nicholson G, Ravits J, Shaw PJ, Swash M, Talbot K, Traynor BJ, Van den Berg LH, Veldink JH, Vucic S, Kiernan MC. Controversies and priorities in amyotrophic lateral sclerosis. Lancet Neurol. 2013 Mar;12(3):310-22. doi: 10.1016/S1474-4422(13)70036-X.
- Background: PubMed 15672628Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
- Background: PubMed 21377202van Middendorp JJ, Hosman AJ, Donders AR, Pouw MH, Ditunno JF Jr, Curt A, Geurts AC, Van de Meent H; EM-SCI Study Group. A clinical prediction rule for ambulation outcomes after traumatic spinal cord injury: a longitudinal cohort study. Lancet. 2011 Mar 19;377(9770):1004-10. doi: 10.1016/S0140-6736(10)62276-3. Epub 2011 Mar 4.
- Background: PubMed 34928697Fessler EB, Brown RT, Miller RK. Rebooting Instrumental Activities of Daily Living for the 21st Century. Ann Intern Med. 2022 Feb;175(2):278-279. doi: 10.7326/M21-3065. Epub 2021 Dec 21. No abstract available.
- Background: PubMed 36353265Lu X, Yao Y, Jin Y. Digital exclusion and functional dependence in older people: Findings from five longitudinal cohort studies. EClinicalMedicine. 2022 Oct 31;54:101708. doi: 10.1016/j.eclinm.2022.101708. eCollection 2022 Dec.
- Background: PubMed 39163564Mois G, Rogers WA. Developing a Framework for Digital Activities of Daily Living. Gerontologist. 2024 Oct 1;64(10):gnae110. doi: 10.1093/geront/gnae110.
- Background: PubMed 20883120Rigby P, Ryan SE, Campbell KA. Electronic aids to daily living and quality of life for persons with tetraplegia. Disabil Rehabil Assist Technol. 2011;6(3):260-7. doi: 10.3109/17483107.2010.522678. Epub 2010 Oct 1.
- BackgroundFairman, A. D., Indradhirmaya, F. A., Osal, R. B. & Saptono, A. Iterative User-Centered Design of the Mobile Device Assessment Tool (MoDAT). Technologies 13, 358 (2025).
- WHO- Global report on assistive technologyLink provided by the sponsor.
- CMS- IRF-PAI Section GGLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Tracker, Mouth Operated Joystick and Non-invasive electroencephalogram (EEG) Headset in people with Spinal Cord Injury and ALS (Amyotrophic Lateral Sclerosis), run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arun Jayaraman, PT, PhD (312-238-6875, ajayaraman@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Outcomes (PerfOs) (time frame: Through study completion, every visit during the Digital Assessment Interface.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07407725, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.