Amyotrophic Lateral SclerosisNCT04026581
Real World Testing of a Brain-Computer Interface
An observational study of Amyotrophic Lateral Sclerosis and Brain Stem Stroke, run by University of Pittsburgh at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Brain Stem Stroke, Cerebral Palsy
- What is being tested?
- Speech generating device (SGD) evaluation including BCI access and Training and treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2019to 30 Sep 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with severe communication disabilities and minimal movement impairment.
Who may be able to join
- 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
Who cannot join
- history of photosensitive epilepsy
- open sores on the scalp
- history of uncorrectable hearing loss
- unavailable to participate during the times scheduled for the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AAC Institute Clinic (ICAN Talk Clinic)
Carnegie, Pennsylvania, 15102
University of Pittsburgh, AAC Performance and Testing Laboratory
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System
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.
Read the detailed description
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.
- Conditions
- Amyotrophic Lateral Sclerosis, Brain Stem Stroke, Cerebral Palsy, Traumatic Brain Injury, Speech Disorders
- Being tested
- Speech generating device (SGD) evaluation including BCI access, Training and treatment
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Cerebral Palsy, Brain Injuries, Traumatic, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech generating device (SGD) evaluation including BCI accessBehavioural
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 treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Assessment | A comprehensive AAC assessment collecting clinical and personal data required to select a speech-generating device (SGD) is conducted along with a trial of three AAC technology solutions, followed by a trial for BCI access to an AAC system. Receives: Behavioral: Speech generating device (SGD) evaluation including BCI access | |
| Training and Treatment | AAC training and treatment services will be provided and communication performance outcomes monitored over the course of studying clinical treatment services. At monthly home visits the SLP gathers clinical and personal data on communication performance outcomes and user satisfaction of their AAC system and any alternative access methods. Receives: Behavioral: Training and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: Baseline vs. 1 month
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 1 month vs. 2 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 2 months vs. 3 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 3 months vs. 4 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 4 months vs. 5 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 5 months vs. 6 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 6 months vs. 7 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 7 months vs. 8 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 8 months vs. 9 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 9 months vs. 10 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 10 months vs. 11 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 11 months vs. 12 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 12 months vs. 13 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 13 months vs. 14 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 14 months vs. 15 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 15 months vs. 16 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 16 months vs. 17 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 17 months vs. 18 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 18 months vs. 19 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 19 months vs. 20 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 20 months vs. 21 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 21 months vs. 22 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 22 months vs. 23 months
Change in daily communication performance
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Measured: 23 months vs. 24 months
Secondary outcomes (24)
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: Baseline vs. 1 month
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 1 month vs. 2 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 2 months vs. 3 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 3 months vs. 4 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 4 months vs. 5 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 5 months vs. 6 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 6 months vs. 7 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 7 months vs. 8 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 8 months vs. 9 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 9 months vs. 10 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 10 months vs. 11 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 11 months vs. 12 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 12 months vs. 13 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 13 months vs. 14 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 14 months vs. 15 months
User satisfaction of speech generating device (SGD) or daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 15 months vs. 16 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 16 months vs. 17 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 17 months vs. 18 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 18 months vs. 19 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 19 months vs. 20 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 20 months vs. 21 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 21 months vs. 22 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 22 months vs. 23 months
User satisfaction of speech generating device (SGD) for daily communication
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
Measured: 23 months vs. 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start5 Jun 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Katya Hill, University of Pittsburgh
- Investigators
- Katya Hill, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026581
- Sponsor's protocol ID
- STUDY19010094
- Other IDs
- 90IFDV0002-01-00
- Status last verified
- Dec 2023
- First submitted
- 17 Jul 2019
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System
- ClinicalTrials.gov ID
- NCT04026581
- Acronym / sponsor ID
- STUDY19010094
- Conditions
- Amyotrophic Lateral Sclerosis, Brain Stem Stroke, Cerebral Palsy, Traumatic Brain Injury, Speech Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Jul 2019 (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 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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment | – | Behavioral: Speech generating device (SGD) evaluation including BCI accessA comprehensive AAC assessment collecting clinical and personal data required to select a speech-generating device (SGD) is conducted along with a trial of three AAC technology solutions, followed by a trial for BCI access to an AAC system. |
| Training and Treatment | – | Behavioral: Training and treatmentAAC training and treatment services will be provided and communication performance outcomes monitored over the course of studying clinical treatment services. At monthly home visits the SLP gathers clinical and personal data on communication performance outcomes and user satisfaction of their AAC system and any alternative access methods. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with severe communication disabilities and minimal movement impairment.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- history of photosensitive epilepsy
- open sores on the scalp
- history of uncorrectable hearing loss
- unavailable to participate during the times scheduled for the study
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 |
|---|---|---|
| Speech generating device (SGD) evaluation including BCI accessAt 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. | Behavioural | Assessment |
| Training and treatmentParticipants 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. | Behavioural | Training and Treatment |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
24 secondary outcomes
User satisfaction of speech generating device (SGD) for daily communication
Time frame: Baseline vs. 1 month
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 1 month vs. 2 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 2 months vs. 3 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 3 months vs. 4 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 4 months vs. 5 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 5 months vs. 6 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 6 months vs. 7 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 7 months vs. 8 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 8 months vs. 9 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 9 months vs. 10 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 10 months vs. 11 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 11 months vs. 12 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 12 months vs. 13 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 13 months vs. 14 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 14 months vs. 15 months
User satisfaction of speech generating device (SGD) or daily communication
Time frame: 15 months vs. 16 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 16 months vs. 17 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 17 months vs. 18 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 18 months vs. 19 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 19 months vs. 20 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 20 months vs. 21 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 21 months vs. 22 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 22 months vs. 23 months
User satisfaction of speech generating device (SGD) for daily communication
Time frame: 23 months vs. 24 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 6 Dec 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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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.
Katya Hill, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Brain Stem Stroke, run by University of Pittsburgh 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 6 inclusion and 4 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 Dec 2023. 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?
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?
Change in daily communication performance (time frame: Baseline vs. 1 month). The study lists 24 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 6 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.