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Completed

NCT Number: NCT04026581

Real World Testing of a Brain-Computer Interface

The goal of this project is to test a new AAC-BCI device comparing gel and dry electrode headgear used for communication while providing clinical care. Innovative resources will be employed to support the standard of care without considering limitations based on service billing codes. Clinical services will include AAC assessment, AAC-BCI device and treatment to individuals with minimal movement due to amyotrophic lateral sclerosis (ALS), brain stem strokes, severe cerebral palsy, traumatic brain injury (TBI) and their family support person. This is a descriptive study designed to measure and monitor the communication performance of individuals using the AAC-BCI, any other AAC strategies, their user satisfaction and perceptions of communication effectiveness, and the satisfaction of the family support persons.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Brain Damage, Chronic Brain Diseases Brain Infarction Brain Injuries Brain Injuries, Traumatic Brain Ischemia Brain Stem Infarctions Brain Stem Stroke Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Communication Disorders Craniocerebral Trauma Infarction Ischemia Language Disorders Metabolic Diseases Motor Neuron Disease Necrosis Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Speech Disorders Spinal Cord Diseases Stroke TDP-43 Proteinopathies Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AAC Institute Clinic (ICAN Talk Clinic), Carnegie, Pennsylvania, United States

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About this study

This clinical trial follows a descriptive study design collecting data to measure and monitor variables related to the standard of care in providing speech language pathology augmentative and alternative communication clinical (AAC) assessment and treatment. The study tracks participants through the AAC, speech generating device trial and AAC-BCI trial processes. In addition this study measures and monitors the communication performance of individuals using the AAC-BCI and any other AAC strategies for treatment in the home. Data on communication performance, user satisfaction, and perceptions of communication effectiveness are gathered over monthly visits along with the satisfaction and perceptions of communication effectiveness by the family support persons.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • natural speech does not meet daily communication needs requiring using a speech generating device
  • Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
  • age 14 and above
  • able to read a standard computer screen
  • able to follow instructions
  • English as their native language

Exclusion criteria

  • history of photosensitive epilepsy
  • open sores on the scalp
  • history of uncorrectable hearing loss
  • unavailable to participate during the times scheduled for the study

Treatment and study plan

Speech generating device (SGD) evaluation including BCI access

Behavioral

At the initial evaluation the participants will review the full range of AAC options and speech generating devices (SGDs) and complete a speech and language evaluation. The second evaluation date will involve a trial of SGDs matched to the participant's assessment results. The third visit is the trial of an AAC system with BCI access. Should the dry electrode headgear for BCI access prove ineffective, then the gel electrode cap will be offered to the participant for trial. At the end of the third visit, the evaluation results will be discussed with participant and family, and they will be asked to select the preferred SGD.

Training and treatment

Behavioral

Participants receive training on the selected SGD followed by monthly treatment sessions from the SLP who monitors performance. In some cases the participants' SGD will be an AAC system with BCI access. In this case training will also include an identified system support person. Use of the SGD is monitored on a monthly basis through home visits and/or tele-practice sessions, when requested. Technical support for the SGD is provided on an as needed basis or when requested by the participant or support person.

Primary outcomes

  1. Change in daily communication performance

    Time frame: Baseline vs. 1 month

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  2. Change in daily communication performance

    Time frame: 1 month vs. 2 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  3. Change in daily communication performance

    Time frame: 2 months vs. 3 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  4. Change in daily communication performance

    Time frame: 3 months vs. 4 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  5. Change in daily communication performance

    Time frame: 4 months vs. 5 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  6. Change in daily communication performance

    Time frame: 5 months vs. 6 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  7. Change in daily communication performance

    Time frame: 6 months vs. 7 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  8. Change in daily communication performance

    Time frame: 7 months vs. 8 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  9. Change in daily communication performance

    Time frame: 8 months vs. 9 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  10. Change in daily communication performance

    Time frame: 9 months vs. 10 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  11. Change in daily communication performance

    Time frame: 10 months vs. 11 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  12. Change in daily communication performance

    Time frame: 11 months vs. 12 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  13. Change in daily communication performance

    Time frame: 12 months vs. 13 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  14. Change in daily communication performance

    Time frame: 13 months vs. 14 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  15. Change in daily communication performance

    Time frame: 14 months vs. 15 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  16. Change in daily communication performance

    Time frame: 15 months vs. 16 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  17. Change in daily communication performance

    Time frame: 16 months vs. 17 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  18. Change in daily communication performance

    Time frame: 17 months vs. 18 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  19. Change in daily communication performance

    Time frame: 18 months vs. 19 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  20. Change in daily communication performance

    Time frame: 19 months vs. 20 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  21. Change in daily communication performance

    Time frame: 20 months vs. 21 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  22. Change in daily communication performance

    Time frame: 21 months vs. 22 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  23. Change in daily communication performance

    Time frame: 22 months vs. 23 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

  24. Change in daily communication performance

    Time frame: 23 months vs. 24 months

    Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

Secondary outcomes

  1. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: Baseline vs. 1 month

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  2. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 1 month vs. 2 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  3. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 2 months vs. 3 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  4. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 3 months vs. 4 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  5. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 4 months vs. 5 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  6. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 5 months vs. 6 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  7. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 6 months vs. 7 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  8. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 7 months vs. 8 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  9. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 8 months vs. 9 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  10. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 9 months vs. 10 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  11. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 10 months vs. 11 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  12. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 11 months vs. 12 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  13. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 12 months vs. 13 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  14. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 13 months vs. 14 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  15. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 14 months vs. 15 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  16. User satisfaction of speech generating device (SGD) or daily communication

    Time frame: 15 months vs. 16 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  17. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 16 months vs. 17 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  18. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 17 months vs. 18 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  19. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 18 months vs. 19 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  20. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 19 months vs. 20 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  21. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 20 months vs. 21 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  22. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 21 months vs. 22 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  23. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 22 months vs. 23 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

  24. User satisfaction of speech generating device (SGD) for daily communication

    Time frame: 23 months vs. 24 months

    Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2019
Registry last updated
Dec 6, 2023

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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