An observational study in Amyotrophic Lateral Sclerosis, Brain Stem Stroke and Cerebral Palsy, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by University of Pittsburgh · Observational
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.
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.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's enrollment of 19 is below the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals with severe communication disabilities and minimal movement impairment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Speech generating device (SGD) evaluation including BCI access
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.
Behavioral: Training and treatment
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 23 months vs. 24 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 23 months vs. 24 months
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee.
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Sep 2023, 51 months.
Of 127 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's 51 months is below that.
Counting every sponsor, half of 136 studies reached it within 64 months; a quarter within 29 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amyotrophic Lateral Sclerosis →