Communication DisordersNCT06337188
Adaptive and Individualized AAC Phase II
A study testing Experimental AAC and Generic AAC in people with Communication Disorders, run by Altec Inc. at 1 site in United States.
Trial summary
The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Communication Disorders
- What is being tested?
- Experimental AAC and Generic AAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to 1 Mar 2026
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults or Children; age greater than or equal to 6 y.o.
- Male or female
- Able to (a) spell, (b) follow 2-3 step directions, (c) read 40 point text
- Have complex communication needs representing a broad spectrum of developmental and acquired severe motor impairments resulting from high spinal cord injury (SCI), chronic Guillain-Barre syndrome, brain stem stroke, cerebral palsy (CP), locked-in syndrome, among others.
- Requires the use of an alternative access strategy to communicate and/or use technology that has been clinically prescribed and manually optimized following current clinical standards.
- Sufficient control and voluntary muscle activation on either the head, hand, or foot (on the basis of clinical evaluation by clinical collaborators at University of Nebraska Medical Center) to use the proposed wearable AAC system for the purpose of this study.
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- Sufficient stamina and developmental maturity (on the basis of clinical evaluation by clinical collaborators at University of Nebraska Medical Center) to attend to the approximately 1-2 hour protocols outlined in Aims 2 and 3 without excess fatigue or distraction.
- Availability for at least 5 testing sessions over the study period.
- No medical or safety restrictions of active head, hand, or foot movement (as determined by clinical collaborators at University of Nebraska Medical Center).
- Clinical evidence of preserved cognition by a score of 0 or 1 on NIHSS Consciousness and Communication item.
- Ability to voluntarily blink eyes or raise eyebrows on command (for head selection) or contract fingers/hand grasp (for hand selection) or rotate foot (for foot selection).
- Able to provide written, informed consent or an accompanying communication partner or parent/guardian (for individuals under 18 y.o) to provide written, informed consent/assent to participate in the study.
- Able to speak and follow directions in English.
Who cannot join
- Non-English speaker.
- Inability to follow simple instructions in English.
- Medical history of musculoskeletal conditions (arthritis, spondylosis, etc.) that causes pain on head, hand, or foot movement.
- Restricted active or passive rotation of head and neck resulting from unstable vertebral, spinal cord, or nerve roots that places the subject at risk for execution of the protocol.
- Medical history of cardiac or respiratory complications, or similar disorders that would severely reduce stamina and/or place the subject at risk for conducting the different motor activities.
- Unable to provide informed assent/consent in English.
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
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Susan Fager, Ph.D., 402-559-0426, sfager@unmc.edu
Jessica Gormley, Ph.D., 402-559-6460, jessica.gormley@unmc.edu
About this study
The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication.
Read the detailed description
The investigators propose an AAC device comprising a versatile access method that automatically learns and customizes a keyboard interface to the residual motor function of the individual. The team comprising scientists, speech researchers and clinicians is developing a prototype AAC system comprising versatile access method and personalized, comprehensive communication software. This will be achieved by developing hardware to support streamlined access across multiple points on the body, designing automated algorithms to rapidly create an expanded AAC interface, inclusive of letters, numbers, symbols, emojis, and word completion options, that is personalized based on the residual motor function of user-specific access points, creating software for point-of-care use of the access technology and interface, and evaluating the resulting AAC system for communication efficacy in individuals with severe motor impairments. The milestone will be to demonstrate that our AAC system improves Information Transfer Rate (ITR) and user experience over conventional AAC devices. The final AAC deliverable will be easily integrated with existing AAC tablets and mobile devices to provide those in need of alternative communication methods with an automatically customized, efficient, and intuitive solution to restore communication access in their daily lives. The project's involvement of human subjects for the purpose of research is primarily focused on testing our AAC system for usability, improved performance, acceptance, and perceived benefit among individuals with severe motor impairments.
- Conditions
- Communication Disorders
- Being tested
- Experimental AAC, Generic AAC
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental AACDevice
Participant receives an AAC system comprising 2 wearable sensors for movement-mediated cursor control and muscle activity mediated cursor selection that is integrated with an adaptive and individualized keyboard to test communication performance.
Generic AACDevice
Participant receives an AAC system that is similar to that used to satisfy their normal daily communication needs such as an eye-tracking device with a generic AAC keyboard to test communication.
| Study group | Role | What they receive |
|---|---|---|
| Experimental and Generic Communication Interfaces for AAC | Experimental | Each participant receives both Experimental and Generic AAC systems to communicate - in that order. Receives: Device: Experimental AAC; Device: Generic AAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)
Measures quantitative ratings on the TSQ-WT scale from a minimum rating of 0 to a maximum rating of 4, where the higher value means a better outcome.
Measured: 1 year
Information Transfer Rate
Measures the speed in meters/second of accurately moving a cursor to a specified target on a computer screen.
Measured: 1 year
National Aeronautics and Space Administration (NASA) Task Load Index
Measures qualitative ratings that are rated on an interval scale ranging from low (1) to high (100) of perceived user demand, performance, effort, and frustration.
Measured: 1 year
Secondary outcomes (4)
Character-to-character Movement Time
Measures the duration in seconds required to move a cursor to a specified target on a computer screen.
Measured: 1 year
Path Efficiency
Measures the ratio of an ideal cursor path between targets to the actual path traveled.
Measured: 1 year
Frequency of Selecting Word Completion Options
Measures the number of times per session a predicted word is chosen in place of spelling out the individual letters of the word.
Measured: 1 year
Number of Written Disfluencies
Measures the number of times per session a target is substituted, inserted, or deleted as well as the number of pauses between target selections.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start3 Dec 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication DisordersStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Gianluca De Luca, M.S., Principal investigator, Altec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337188
- Sponsor's protocol ID
- AAC PhII
- Status last verified
- Sep 2025
- First submitted
- 18 Mar 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive and Individualized AAC Phase II
- ClinicalTrials.gov ID
- NCT06337188
- Acronym / sponsor ID
- AAC PhII
- Conditions
- Communication Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Altec Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Nebraska
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 29 Mar 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 overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication.
Detailed description
The investigators propose an AAC device comprising a versatile access method that automatically learns and customizes a keyboard interface to the residual motor function of the individual. The team comprising scientists, speech researchers and clinicians is developing a prototype AAC system comprising versatile access method and personalized, comprehensive communication software. This will be achieved by developing hardware to support streamlined access across multiple points on the body, designing automated algorithms to rapidly create an expanded AAC interface, inclusive of letters, numbers, symbols, emojis, and word completion options, that is personalized based on the residual motor function of user-specific access points, creating software for point-of-care use of the access technology and interface, and evaluating the resulting AAC system for communication efficacy in individuals with severe motor impairments. The milestone will be to demonstrate that our AAC system improves Information Transfer Rate (ITR) and user experience over conventional AAC devices. The final AAC deliverable will be easily integrated with existing AAC tablets and mobile devices to provide those in need of alternative communication methods with an automatically customized, efficient, and intuitive solution to restore communication access in their daily lives. The project's involvement of human subjects for the purpose of research is primarily focused on testing our AAC system for usability, improved performance, acceptance, and perceived benefit among individuals with severe motor impairments.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental and Generic Communication Interfaces for AAC | Experimental | Device: Experimental AAC, Device: Generic AACEach participant receives both Experimental and Generic AAC systems to communicate - in that order. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Adults or Children; age greater than or equal to 6 y.o.
- Male or female
- Able to (a) spell, (b) follow 2-3 step directions, (c) read 40 point text
- Have complex communication needs representing a broad spectrum of developmental and acquired severe motor impairments resulting from high spinal cord injury (SCI), chronic Guillain-Barre syndrome, brain stem stroke, cerebral palsy (CP), locked-in syndrome, among others.
- Requires the use of an alternative access strategy to communicate and/or use technology that has been clinically prescribed and manually optimized following current clinical standards.
Key exclusion criteria (6 listed)
- Non-English speaker.
- Inability to follow simple instructions in English.
- Medical history of musculoskeletal conditions (arthritis, spondylosis, etc.) that causes pain on head, hand, or foot movement.
- Restricted active or passive rotation of head and neck resulting from unstable vertebral, spinal cord, or nerve roots that places the subject at risk for execution of the protocol.
- Medical history of cardiac or respiratory complications, or similar disorders that would severely reduce stamina and/or place the subject at risk for conducting the different motor activities.
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 |
|---|---|---|
| Experimental AACParticipant receives an AAC system comprising 2 wearable sensors for movement-mediated cursor control and muscle activity mediated cursor selection that is integrated with an adaptive and individualized keyboard to test communication performance. | Device | Experimental and Generic Communication Interfaces for AAC |
| Generic AACParticipant receives an AAC system that is similar to that used to satisfy their normal daily communication needs such as an eye-tracking device with a generic AAC keyboard to test communication. | Device | Experimental and Generic Communication Interfaces for AAC |
Primary outcome
Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)
Time frame: 1 year
Measures quantitative ratings on the TSQ-WT scale from a minimum rating of 0 to a maximum rating of 4, where the higher value means a better outcome.
Information Transfer Rate
Time frame: 1 year
Measures the speed in meters/second of accurately moving a cursor to a specified target on a computer screen.
National Aeronautics and Space Administration (NASA) Task Load Index
Time frame: 1 year
Measures qualitative ratings that are rated on an interval scale ranging from low (1) to high (100) of perceived user demand, performance, effort, and frustration.
4 secondary outcomes
Character-to-character Movement Time
Time frame: 1 year
Path Efficiency
Time frame: 1 year
Frequency of Selecting Word Completion Options
Time frame: 1 year
Number of Written Disfluencies
Time frame: 1 year
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 30 Sep 2025.
- 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.
Gianluca De Luca, M.S. principal investigator
Altec Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental AAC and Generic AAC in people with Communication Disorders, run by Altec Inc. 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 13 inclusion and 6 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 30 Sep 2025. 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 Bhawna Shiwani, M.S. (5085458217, bshiwani@altecresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.