Non-Verbal CommunicationNCT06521736
Brain-computer Interface Commercial Readiness
A study testing AAC-BCI device in people with Non-Verbal Communication and Degenerative Neurologic Disease, run by Kendrea Garand at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for people with minimal movement who benefit from expressive communication technology. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Verbal Communication, Degenerative Neurologic Disease
- What is being tested?
- AAC-BCI device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For augmentative and alternative communication, brain-computer interface (AAC-BCI) Users:
- Natural speech does not meet daily communication needs requiring the use of a speech generating device
- Receiving speech therapy from a licensed speech language pathologist
- Has been assessed for and currently using a speech generating device as a means of communication
- Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
- Has a support person who is comfortable with technology, willing to learn a new technology system and is available to set-up the AAC-BCI daily at the user's request.
Show all 26Show fewer
- In-home internet access
- Environment that is suitable for setting up the in-home AAC-BCI system
- Individuals aged 14 or older
- Speaks English
- For Support Persons
- Speaks English
- Willing to be trained to support the AAC-BCI system for the person with a severe disability who uses a speech generating device for communication
- Willing to set-up and clean the AAC-BCI system for at minimum of 10 hours a week up to daily use
- Willing to contact technical support when/if needed for AAC-BCI system
- Willing to complete support person diary documentation
- Able to access In-home internet
- Is 18 years or older
- For PRC Regional Consultants
- 2 or more years of experience as a PRC regional consultant
- 2 or more years of experience providing support to speech-language pathologists working with patients with complex communication needs and movement disorders
- 2 or more years of experience providing support to customers with complex communication needs and movement disorders
- received training on AAC-BCI system
- For Clinicians:
- Licensed speech-language pathologist with AAC experience -Currently treating clients who require AAC support-
- Received AAC-BCI training
Who cannot join
- For AAC-BCI Users:
- Does not own or use a speech generating device
- Unable to participate during the scheduled time periods
- History of photosensitive epilepsy
- History of uncorrectable hearing loss
- Unable to participate during scheduled times
Show all 21Show fewer
- Has a history of open scores on the scalp
- Does not speak English
- For Support Persons:
- Unable to participate during the scheduled time periods
- Can not attend the in-home training sessions
- --Does not speak English
- Does not know how to use the internet
- For PRC Regional Consultants:
- Unable to recommend a speech-language pathologist in their territory
- Unable to recommend an individual with a complex communication and movement disorder.
- For Clinicians:
- Does not have a certificate of clinical competence from the American Speech Language Hearing Association (ASHA)
- Unable to recommend a client to participate with a support person for the clinical trial
- Unable to participate in a 2-day training on the AAC-BCI system
- Unable to participate during the scheduled time periods
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Compatibility Between Brain-Computer Interface and High Efficiency Augmentative and Alternative Communication Systems: Commercial Readiness
The goal of this clinical trial is to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for people with minimal movement who benefit from expressive communication technology. Our clinical trial focuses on up to 8 AAC-BCI users but involves a team of support participants with different roles: an industry partner's consultant, a speech language pathologist (SLP), and the user's in-home support person. Patient and team reported outcome measures data will be collected on usage, performance, reliability and comfort along with performance data of using the AAC-BCI device in the home.
Read the detailed description
Our clinical trial focuses on 8 Alternative Communication Brain-Computer Interface (AAC-BCI) users but involves a team of support participants with different roles: an industry partner's consultant, a speech language pathologist (SLP) and the user's in-home support person. The AAC-BCI user and support person will be recruited from the SLP's clinic and screened to confirm that the individuals meet the inclusion and exclusion criteria before enrollment. The investigators intend to recruit users with a perceived need for Brain-Computer Interface (BCI) access, ex: eye gaze access is deteriorating, unable to determine another access method. The investigators expect that our user participants will be in late-stage amyotrophic lateral sclerosis (ALS), diagnosed with a brainstem stroke, other degenerative neurologic disorder such as Kennedy disease, or have severe quadriplegic cerebral palsy. The support person will be screened to ensure they are comfortable with technology, learning innovative technology and are available to set-up the AAC-BCI daily at the user's request. The home must have internet. A total of 8 enrolled users means that the investigators will have up to 16 team members supported by a consultant. All clinical trial activity will occur in the home. Once consented and enrolled, the first training session with set-up and calibration will occur with the SLP and PRC consultant. The support person must be present. A second training session with a calibration check and use and training on electroencephalogram (EEG) and logfile data collection will occur within one week. The following baseline data will be collected by the consultant and SLP: 1) A functional rating scale; 2) copy spell task (15 minutes); 3) free spell task (15 minutes); National Aeronautics and Space Administration (NASA) Task Load Index (TLX).
The roles of the team members are as follows:
- Industry partner's consultant: Participate in initial and follow-up AAC-BCI training sessions, provide technology support as needed via phone call, virtual meeting, or home visit. Complete required inventory and data forms. Conduct monthly home visits.
- Speech Language Pathologist (SLP): Participate in initial and follow-up AAC-BCI training sessions. Provide treatment and standard of clinical care as needed via phone call, virtual meeting, or home visit. Complete required data forms related to clinical care and support. Complete inventory and data forms.
- AAC-BCI User: Participate in initial set-up, calibration, and training sessions. Use at home at least 10 hours a week with EEG activity. Use system for daily communication during time they are wearing it. Participate in monthly home visit with SLP and weekly follow-up call with researcher to collect data. Complete surveys on effectiveness when trying to communicate and effectiveness when not trying to communicate.
- Support Person: Participate in initial set-up, calibration, and training sessions. Agree to set-up for AAC-BCI user in the home so that the user is wearing the headgear, and the EEG electrodes are active for at least 10 hours a week. Complete recommended cleaning and storage of equipment after use. Participate at monthly visits with consultant, contacts with the SLP and weekly call with researchers. Complete data collection forms.
At the end of the 6-month study, participants will complete a Qualtrics survey to rate the overall commercial readiness of the AAC-BCI device along with rating the AAC-BCI device on satisfaction, performance, reliability, and comfort.
- Being tested
- AAC-BCI device
- Keywords
- speech generating device, user-satisfaction, performance
- Medical subject headings
- Nonverbal Communication, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAC-BCI deviceDevice
Participants without speech and severe movement disorders will be trained on the augmentative and alternative communication, brain-computer interface (AAC-BCI) system, using it for at least 10 hours per week in their homes for communication and other control functions. Participants will have daily support for using the AAC-BCI from trained caregivers along with intervention support from consultants and speech language pathologists.
| Study group | Role | What they receive |
|---|---|---|
| Testing commercial readiness of an AAC-BCI device | Experimental | Participants with severe movement disabilities will use the augmentative and alternative communication, brain-computer interface (AAC-BCI) device at least 10 hours a week in their homes receiving supported from a caregiver, speech language pathologist and consultant and rate the intervention on user satisfaction, performance, reliability, comfort and overall readiness for commercialization. Receives: Device: AAC-BCI device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Commercial readiness of augmentative and alternative communication brain-computer interface (AAC-BCI) system.
Stakeholder participants agree "yes" that the Alternative Communication Brain-Computer Interface (AAC-BCI) system is ready for product release with an average combined agreement of 70% on a binary yes/no scale.
Measured: 6 months
Secondary outcomes (4)
Alternative Communication Brain-Computer Interface (AAC-BCI) system user-satisfaction
Participants rate degree of satisfaction associated with use of the Alternative Communication Brain-Computer Interface (AAC-BCI) system for communication using a five-point Likert Scale where 1= Very Dissatisfied, 2= Dissatisfied, 3= Neither Satisfied or Dissatisfied, 4= Satisfied, and 5= Very Satisfied; 1-3 is a negative outcome, and 4-5 are a positive outcome.
Measured: 6 months
Alternative Communication Brain-Computer Interface (AAC-BCI) system performance
Participants rate degree of satisfaction with the overall performance of the Alternative Communication Brain-Computer Interface (AAC-BCI) system during communication using a five-point Likert Scale where 1= Very Dissatisfied, 2= Dissatisfied, 3= Neither Satisfied or Dissatisfied, 4= Satisfied, and 5= Very Satisfied; 1-3 is a negative outcome, and 4-5 are a positive outcome.
Measured: 6 months
Alternative Communication Brain-Computer Interface (AAC-BCI) system reliability
Participants rate degree of satisfaction with the overall reliability of the Alternative Communication Brain-Computer Interface (AAC-BCI) system features and functions during daily use using a five-point Likert Scale where 1= Very Dissatisfied, 2= Dissatisfied, 3= Neither Satisfied or Dissatisfied, 4= Satisfied, and 5= Very Satisfied; 1-3 is a negative outcome, and 4-5 are a positive outcome.
Measured: 6 months
Alternative Communication Brain-Computer Interface (AAC-BCI) system comfort
Participant rate degree of satisfaction with the overall comfort of using the Alternative Communication Brain-Computer Interface (AAC-BCI) system during daily use using a five-point Likert Scale where 1= Very Dissatisfied, 2= Dissatisfied, 3= Neither Satisfied or Dissatisfied, 4= Satisfied, and 5= Very Satisfied; 1-3 is a negative outcome, and 4-5 are a positive outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start13 Sep 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Verbal CommunicationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical trial employs a Single Group Assignment model to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for individuals with minimal movement capabilities. The study involves up to 8 AAC-BCI users diagnosed with conditions such as late-stage amyotrophic lateral sclerosis (ALS), brainstem stroke, or severe quadriplegic cerebral palsy, supported by an industry partner's consultant, a speech language pathologist (SLP), and the user's in-home support person. Participants will be trained on the device, using it at least 10 hours per week at home. The primary objective is to achieve 80% stakeholder agreement on the device's readiness for product release. Secondary objectives focus on safety, performance, and user satisfaction. The study's design ensures comprehensive data collection on the AAC-BCI system's usability and performance, providing critical insights for future development and larger-scale trials.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kendrea Garand
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Michigan, PRC
- Responsible party
- Sponsor-investigator, Kendrea Garand, University of Pittsburgh
- Investigators
- Katharine J Hill, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521736
- Sponsor's protocol ID
- STUDY24040169
- Other IDs
- 2SB1DC015142-04
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data shared with other investigators will all be de-identified and not traceable back to any specific participant. Data Use Agreements will be in place prior to the transferring of any data leaving the institution. Published primary research data developed with federal funding will be shared on request by other researchers in accordance with University and federal policies (i.e. National Institutes of Health (NIH) and/or National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) ). Mr. Malcomson (PRC) and Dr. Huggins at the University of Michigan do not have access to any of the research documents, but analyzed data results will be shared to review progress and reporting.
Publications
Hill K, Kovacs T, Shin S. Reliability of brain-computer interface language sample transcription procedures. J Rehabil Res Dev. 2014;51(4):579-90. doi: 10.1682/JRRD.2013.05.0102.
PubMed 25144171Hill K, Kovacs T, Shin S. Critical issues using brain-computer interfaces for augmentative and alternative communication. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S8-15. doi: 10.1016/j.apmr.2014.01.034.
PubMed 25721552Huggins JE, Alcaide-Aguirre RE, Hill K. Effects of text generation on P300 brain-computer interface performance. Brain Comput Interfaces (Abingdon). 2016;3(2):112-120. doi: 10.1080/2326263X.2016.1203629. Epub 2016 Jul 4.
PubMed 28261630Hill K, Huggins J, Woodworth C. Interprofessional Practitioners' Opinions on Features and Services for an Augmentative and Alternative Communication Brain-Computer Interface Device. PM R. 2021 Oct;13(10):1111-1121. doi: 10.1002/pmrj.12525. Epub 2021 Jan 23.
PubMed 33236859
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compatibility Between Brain-Computer Interface and High Efficiency Augmentative and Alternative Communication Systems: Commercial Readiness
- ClinicalTrials.gov ID
- NCT06521736
- Acronym / sponsor ID
- STUDY24040169
- Keywords
- speech generating device, user-satisfaction, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Kendrea GarandUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Michigan, PRC
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 26 Jul 2024 (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.
The goal of this clinical trial is to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for people with minimal movement who benefit from expressive communication technology. Our clinical trial focuses on up to 8 AAC-BCI users but involves a team of support participants with different roles: an industry partner's consultant, a speech language pathologist (SLP), and the user's in-home support person. Patient and team reported outcome measures data will be collected on usage, performance, reliability and comfort along with performance data of using the AAC-BCI device in the home.
Detailed description
Our clinical trial focuses on 8 Alternative Communication Brain-Computer Interface (AAC-BCI) users but involves a team of support participants with different roles: an industry partner's consultant, a speech language pathologist (SLP) and the user's in-home support person. The AAC-BCI user and support person will be recruited from the SLP's clinic and screened to confirm that the individuals meet the inclusion and exclusion criteria before enrollment. The investigators intend to recruit users with a perceived need for Brain-Computer Interface (BCI) access, ex: eye gaze access is deteriorating, unable to determine another access method. The investigators expect that our user participants will be in late-stage amyotrophic lateral sclerosis (ALS), diagnosed with a brainstem stroke, other degenerative neurologic disorder such as Kennedy disease, or have severe quadriplegic cerebral palsy. The support person will be screened to ensure they are comfortable with technology, learning innovative technology and are available to set-up the AAC-BCI daily at the user's request. The home must have internet. A total of 8 enrolled users means that the investigators will have up to 16 team members supported by a consultant. All clinical trial activity will occur in the home. Once consented and enrolled, the first training session with set-up and calibration will occur with the SLP and PRC consultant. The support person must be present. A second training session with a calibration check and use and training on electroencephalogram (EEG) and logfile data collection will occur within one week. The following baseline data will be collected by the consultant and SLP: 1) A functional rating scale; 2) copy spell task (15 minutes); 3) free spell task (15 minutes); National Aeronautics and Space Administration (NASA) Task Load Index (TLX).
The roles of the team members are as follows:
- Industry partner's consultant: Participate in initial and follow-up AAC-BCI training sessions, provide technology support as needed via phone call, virtual meeting, or home visit. Complete required inventory and data forms. Conduct monthly home visits.
- Speech Language Pathologist (SLP): Participate in initial and follow-up AAC-BCI training sessions. Provide treatment and standard of clinical care as needed via phone call, virtual meeting, or home visit. Complete required data forms related to clinical care and support. Complete inventory and data forms.
- AAC-BCI User: Participate in initial set-up, calibration, and training sessions. Use at home at least 10 hours a week with EEG activity. Use system for daily communication during time they are wearing it. Participate in monthly home visit with SLP and weekly follow-up call with researcher to collect data. Complete surveys on effectiveness when trying to communicate and effectiveness when not trying to communicate.
- Support Person: Participate in initial set-up, calibration, and training sessions. Agree to set-up for AAC-BCI user in the home so that the user is wearing the headgear, and the EEG electrodes are active for at least 10 hours a week. Complete recommended cleaning and storage of equipment after use. Participate at monthly visits with consultant, contacts with the SLP and weekly call with researchers. Complete data collection forms.
At the end of the 6-month study, participants will complete a Qualtrics survey to rate the overall commercial readiness of the AAC-BCI device along with rating the AAC-BCI device on satisfaction, performance, reliability, and comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical trial employs a Single Group Assignment model to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for individuals with minimal movement capabilities. The study involves up to 8 AAC-BCI users diagnosed with conditions such as late-stage amyotrophic lateral sclerosis (ALS), brainstem stroke, or severe quadriplegic cerebral palsy, supported by an industry partner's consultant, a speech language pathologist (SLP), and the user's in-home support person. Participants will be trained on the device, using it at least 10 hours per week at home. The primary objective is to achieve 80% stakeholder agreement on the device's readiness for product release. Secondary objectives focus on safety, performance, and user satisfaction. The study's design ensures comprehensive data collection on the AAC-BCI system's usability and performance, providing critical insights for future development and larger-scale trials.
| Arm | Type | Receives |
|---|---|---|
| Testing commercial readiness of an AAC-BCI device | Experimental | Device: AAC-BCI deviceParticipants with severe movement disabilities will use the augmentative and alternative communication, brain-computer interface (AAC-BCI) device at least 10 hours a week in their homes receiving supported from a caregiver, speech language pathologist and consultant and rate the intervention on user satisfaction, performance, reliability, comfort and overall readiness for commercialization. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Natural speech does not meet daily communication needs requiring the use of a speech generating device
- Receiving speech therapy from a licensed speech language pathologist
- Has been assessed for and currently using a speech generating device as a means of communication
- Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
- Has a support person who is comfortable with technology, willing to learn a new technology system and is available to set-up the AAC-BCI daily at the user's request.
Key exclusion criteria (21 listed)
- For AAC-BCI Users:
- Does not own or use a speech generating device
- Unable to participate during the scheduled time periods
- History of photosensitive epilepsy
- History of uncorrectable hearing loss
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 |
|---|---|---|
| AAC-BCI deviceParticipants without speech and severe movement disorders will be trained on the augmentative and alternative communication, brain-computer interface (AAC-BCI) system, using it for at least 10 hours per week in their homes for communication and other control functions. Participants will have daily support for using the AAC-BCI from trained caregivers along with intervention support from consultants and speech language pathologists. | Device | Testing commercial readiness of an AAC-BCI device |
Primary outcome
Commercial readiness of augmentative and alternative communication brain-computer interface (AAC-BCI) system.
Time frame: 6 months
Stakeholder participants agree "yes" that the Alternative Communication Brain-Computer Interface (AAC-BCI) system is ready for product release with an average combined agreement of 70% on a binary yes/no scale.
4 secondary outcomes
Alternative Communication Brain-Computer Interface (AAC-BCI) system user-satisfaction
Time frame: 6 months
Alternative Communication Brain-Computer Interface (AAC-BCI) system performance
Time frame: 6 months
Alternative Communication Brain-Computer Interface (AAC-BCI) system reliability
Time frame: 6 months
Alternative Communication Brain-Computer Interface (AAC-BCI) system comfort
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 25144171Hill K, Kovacs T, Shin S. Reliability of brain-computer interface language sample transcription procedures. J Rehabil Res Dev. 2014;51(4):579-90. doi: 10.1682/JRRD.2013.05.0102.
- Background: PubMed 25721552Hill K, Kovacs T, Shin S. Critical issues using brain-computer interfaces for augmentative and alternative communication. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S8-15. doi: 10.1016/j.apmr.2014.01.034.
- Background: PubMed 28261630Huggins JE, Alcaide-Aguirre RE, Hill K. Effects of text generation on P300 brain-computer interface performance. Brain Comput Interfaces (Abingdon). 2016;3(2):112-120. doi: 10.1080/2326263X.2016.1203629. Epub 2016 Jul 4.
- Background: PubMed 33236859Hill K, Huggins J, Woodworth C. Interprofessional Practitioners' Opinions on Features and Services for an Augmentative and Alternative Communication Brain-Computer Interface Device. PM R. 2021 Oct;13(10):1111-1121. doi: 10.1002/pmrj.12525. Epub 2021 Jan 23.
- Individual participant dataSharing planned: Yes. Data shared with other investigators will all be de-identified and not traceable back to any specific participant. Data Use Agreements will be in place prior to the transferring of any data leaving the institution. Published primary research data developed with federal funding will be shared on request by other researchers in accordance with University and federal policies (i.e. National Institutes of Health (NIH) and/or National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) ). Mr. Malcomson (PRC) and Dr. Huggins at the University of Michigan do not have access to any of the research documents, but analyzed data results will be shared to review progress and reporting.
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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. This study is not recruiting at the moment.
Katharine J Hill, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAC-BCI device in people with Non-Verbal Communication and Degenerative Neurologic Disease, run by Kendrea Garand 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 26 inclusion and 21 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: finished, as of the sponsor's last update on 12 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Commercial readiness of augmentative and alternative communication brain-computer interface (AAC-BCI) system. (time frame: 6 months). 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 NCT06521736, which also lists 4 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 12 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.