Communication DisordersNCT04247828

Adaptive and Individualized AAC

A study testing Experimental AAC and Generic AAC in people with Communication Disorders, run by Altec Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This project will test the feasibility of developing a smart augmentative or alternative communication (AAC) system that is effective in delivering communication capabilities that automatically adapt to the users' physical abilities. Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
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: 30 participants
Where: 2 sitesUnited States
Study dates: 6 Jan 2020to 31 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Control Subjects:
Adults and Children; >12yo
Male or Female
All participants will be: (a) able to spell, (b) able to follow 2-3 step directions, (c) have functional vision sufficient to read 40 point text
No history of communication disorders;
No history of neurological disorders affecting speech or head movement.

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Subjects with SPI:
Adults or Children; age>12yo
Male or Female
All participants will be: (a) able to spell, (b) able to follow 2-3 step directions, (c) have functional vision sufficient to read 40 point text, and (d) have a motor impairment that requires the use of an alternative access strategy to communicate and/or use technology.
Current or prospective AAC user with complex communication needs representing a broad spectrum of developmental and acquired SPI disabilities resulting from high spinal cord injury, chronic Guillain-Barré syndrome, brain stem stroke, cerebral palsy, locked-in syndrome, among others;
Sufficient head control and voluntary facial muscle activation (on the basis of clinical evaluation by Dr. Susan Fager and her team) to use the proposed wearable EMG/IMU sensor for the purposes of this study;
Evidence of at least partial voluntary head movement in at least 2 degrees of freedom (Individual differences in providing controlled movements of the head in various degrees of freedom due to their disease or trauma is not only acceptable but desirable);
Sufficient stamina and developmental maturity (on the basis of clinical evaluation by Dr. Susan Fager) to attend to the approximately 1-hour protocol outlined in Aims 1 and 3 without excess fatigue or distraction;
Availability for at least 3-4 testing sessions over the study period;
No medical or safety restrictions of active head and neck movement (as determined by Dr. Susan Fager in consultation with her clinical team);
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.

Who cannot join

Control Subjects
Non-English speaker;
Inability to follow simple instructions in English;
Restricted ROM of the head or neck;
Pain with head movement
Medical history of cardiac or respiratory complications, or disorders that would place the subject at risk for conducting the different motor activities;

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Skin disorders that result in open lesions or hyper-sensitive/fragile skin on the forehead, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;
Unable to provide informed consent in English.
Subjects with SPI
Non-English speaker;
Inability to follow simple instructions in English;
Medical history of musculoskeletal conditions (arthritis, spondylosis, etc.) that severely limit head movement or causes pain on head 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;
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;
Skin disorders that result in open lesions or hyper-sensitive/fragile skin on the forehead, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;
Unable to provide informed consent in English.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Madonna Rehabilitation Hospital Institute for Rehabilitation Science and Engineering
Lincoln, Nebraska, 68506
Altec Inc.
Natick, Massachusetts, 01760

Other trials in United States

About this study

Read the detailed description

The diversity of the more than 1.3% of Americans who suffer from severe physical impairments (SPIs) preclude the use of common augmentative or alternative communication (AAC) solutions such as manual signs, gestures or interaction with a touchscreen for communication. This clinical trial will test the feasibility of developing a smart-AAC system designed using individually adaptive access methods and AAC interfaces to accommodate the unique manifestations of motor impairments specific to each user. The investigators will demonstrate the proof-of-concept that a single surface electromyographic (sEMG) and inertial measurement unit (IMU) hybrid sensor worn on the forehead can provide improvements in information transfer rate (ITR) and communication accuracy when integrated with an AAC interface that is optimized compared to a conventional (non-adaptable) interface for subjects with SPI.

Conditions: Communication Disorders
Being tested: Experimental AAC, Generic AAC
Keywords: Communication, Severe Physical Impairments, Spinal Cord Injury
Medical subject headings: Communication Disorders, Communication, Spinal Cord Injuries

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 a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptive and individualized keyboard to test communication performance.
Generic AACDevice
Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance.

Study groups in NCT04247828
Study group	Role	What they receive
Experimental and Generic Communication Interfaces for AAC	Experimental	Receives both Experimental and Generic AAC systems to communicate. Each participant will receive both devices, with Experimental AAC presented first (Day 1) and Generic AAC presented second (Day 2; reference). Receives: Device: Experimental AAC; Device: Generic AAC

What is being measured

The primary outcome is the main question the study is designed to answer.

Movement Time
Time needed to navigate a cursor to and select a target on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein lower movement times equate to better performance.
Measured: 1 Day
Path-to-Target Movement Variability
Path smoothness relative to the optimal, straight path between targets on a computer screen by control of head movement and facial muscle contractions for each AAC device. Variability is estimated as a distance of pixels as estimated from a computer screen operating with a resolution of 1920 pixels x 1080 pixels, wherein smaller variability scores equate to better performance.
Measured: 1 Day
Target Selection Accuracy
Percentage of accurate selections of targets on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein higher accuracy scores equate to better performance.
Measured: 1 Day
Information Transfer Rate
Human motor performance relative to the speed and accuracy of cursor-to-target movements on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein higher information transfer rates equate to better performance.
Measured: 1 Day
AAC Device Usability
Self-report of perceived AAC device usability as captured via a Likert scale anchored from 1 ("very difficult") to 7 ("very easy"), wherein higher usability scores equate to better performance.
Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202031 Aug 2021

First posted30 Jan 2020
Study start6 Jan 2020
Primary completion31 Aug 2021
Study completion31 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04247828
Sponsor's protocol ID: AAC Phase I
Status last verified: Feb 2022
First submitted: 21 Jan 2020
Last updated: 6 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Communication Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adaptive and Individualized AAC
ClinicalTrials.gov ID: NCT04247828
Acronym / sponsor ID: AAC Phase I
Conditions: Communication Disorders
Keywords: Communication, Severe Physical Impairments, Spinal Cord Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Altec Inc.Industry (pharma, biotech, devices)
Collaborators: Madonna Rehabilitation Hospital
Study start: 6 Jan 2020 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 30 Jan 2020 (actual)
Results: Posted 6 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 AACReceives both Experimental and Generic AAC systems to communicate. Each participant will receive both devices, with Experimental AAC presented first (Day 1) and Generic AAC presented second (Day 2; reference).

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (18 listed)

Adults and Children; >12yo
Male or Female
All participants will be: (a) able to spell, (b) able to follow 2-3 step directions, (c) have functional vision sufficient to read 40 point text
No history of communication disorders;
No history of neurological disorders affecting speech or head movement.

Key exclusion criteria (16 listed)

Control Subjects
Non-English speaker;
Inability to follow simple instructions in English;
Restricted ROM of the head or neck;
Pain with head movement

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 a single hybrid wearable sensor for head-mediated cursor control 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 comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance.	Device	Experimental and Generic Communication Interfaces for AAC

Primary outcome

Movement Time
Time frame: 1 Day
Time needed to navigate a cursor to and select a target on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein lower movement times equate to better performance.
Path-to-Target Movement Variability
Time frame: 1 Day
Path smoothness relative to the optimal, straight path between targets on a computer screen by control of head movement and facial muscle contractions for each AAC device. Variability is estimated as a distance of pixels as estimated from a computer screen operating with a resolution of 1920 pixels x 1080 pixels, wherein smaller variability scores equate to better performance.
Target Selection Accuracy
Time frame: 1 Day
Percentage of accurate selections of targets on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein higher accuracy scores equate to better performance.
Information Transfer Rate
Time frame: 1 Day
Human motor performance relative to the speed and accuracy of cursor-to-target movements on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein higher information transfer rates equate to better performance.
AAC Device Usability
Time frame: 1 Day
Self-report of perceived AAC device usability as captured via a Likert scale anchored from 1 ("very difficult") to 7 ("very easy"), wherein higher usability scores equate to better performance.

Results and safety

Results posted to the registry on 6 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental and Generic Communication Interfaces for AAC	30	21

Primary outcome: Movement Time

Time frame: 1 Day. Mean (Standard Deviation). Unit: Seconds

Measure	Experimental and Generic Communication Interfaces for AAC n = 21
Experimental AAC	2.5 (1.9)
Generic AAC	2.9 (2.0)

Population analysed: All participants (control, SPI) experienced both the Experimental AAC (Day 1) and Generic AAC (reference, Day 2) devices. Of N=30 participants, N=9 were not analyzed as they could not complete the study protocol due to COVID-19 mandated restrictions in participant recruitment.

Primary outcome: Path-to-Target Movement Variability

Time frame: 1 Day. Mean (Standard Deviation). Unit: pixels

Measure	Experimental and Generic Communication Interfaces for AAC n = 21
Experimental AAC	49.7 (9.4)
Generic AAC	74.0 (9.5)

Primary outcome: Target Selection Accuracy

Time frame: 1 Day. Mean (Standard Deviation). Unit: Percentage of Accurate Target Selections

Measure	Experimental and Generic Communication Interfaces for AAC n = 21
Experimental AAC	96.3 (6.3)
Generic AAC	94.5 (9.8)

Primary outcome: Information Transfer Rate

Time frame: 1 Day. Mean (Standard Deviation). Unit: Bits/min

Measure	Experimental and Generic Communication Interfaces for AAC n = 21
Experimental AAC	45.8 (20.0)
Generic AAC	36.6 (16.2)

Adverse events

Time frame: 3 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental and Generic Communication Interfaces for AAC	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): Not all recruited patients could complete the study protocol due to mandated patient recruitment restrictions resulting from the covid-19 emergency.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.

Related trials for Communication Disorders

Recruiting
Using Non-invasive Brain Stimulation to Explore Potential Treatments to Reduce Speech Errors in Adults Who Stutter
Stuttering, Fluency Disorder
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
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Recruiting
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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.

Paola Contessa, PhD principal investigator

Altec Inc.

2 sites 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 2 sites 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 18 inclusion and 16 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 6 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Movement Time (time frame: 1 Day). The study lists 5 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 NCT04247828.

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 6 Apr 2022.