Real World Testing of a Brain-Computer Interface

Cerebral Palsy Clinical Trial

Official title:

Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026581
• Other study ID #: STUDY19010094
• Secondary ID: 90IFDV0002-01-00
• Status: Completed
• Start date: June 5, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• history of photosensitive epilepsy
• open sores on the scalp
• history of uncorrectable hearing loss
• unavailable to participate during the times scheduled for the study

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Stem Infarctions
• Brain Stem Stroke
• Cerebral Palsy
• Motor Neuron Disease
• Speech Disorders
• Traumatic Brain Injury

Intervention

Behavioral:
• Speech generating device (SGD) evaluation including BCI access
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 treatment
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.

Locations

Country	Name	City	State
United States	AAC Institute Clinic (ICAN Talk Clinic)	Carnegie	Pennsylvania
United States	University of Pittsburgh, AAC Performance and Testing Laboratory	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline vs. 1 month
Primary	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.	1 month vs. 2 months
Primary	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.	2 months vs. 3 months
Primary	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.	3 months vs. 4 months
Primary	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.	4 months vs. 5 months
Primary	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.	5 months vs. 6 months
Primary	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.	6 months vs. 7 months
Primary	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.	7 months vs. 8 months
Primary	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.	8 months vs. 9 months
Primary	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.	9 months vs. 10 months
Primary	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.	10 months vs. 11 months
Primary	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.	11 months vs. 12 months
Primary	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.	12 months vs. 13 months
Primary	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.	13 months vs. 14 months
Primary	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.	14 months vs. 15 months
Primary	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.	15 months vs. 16 months
Primary	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.	16 months vs. 17 months
Primary	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.	17 months vs. 18 months
Primary	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.	18 months vs. 19 months
Primary	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.	19 months vs. 20 months
Primary	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.	20 months vs. 21 months
Primary	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.	21 months vs. 22 months
Primary	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.	22 months vs. 23 months
Primary	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.	23 months vs. 24 months
Secondary	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.	Baseline vs. 1 month
Secondary	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.	1 month vs. 2 months
Secondary	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.	2 months vs. 3 months
Secondary	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.	3 months vs. 4 months
Secondary	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.	4 months vs. 5 months
Secondary	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.	5 months vs. 6 months
Secondary	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.	6 months vs. 7 months
Secondary	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.	7 months vs. 8 months
Secondary	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.	8 months vs. 9 months
Secondary	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.	9 months vs. 10 months
Secondary	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.	10 months vs. 11 months
Secondary	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.	11 months vs. 12 months
Secondary	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.	12 months vs. 13 months
Secondary	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.	13 months vs. 14 months
Secondary	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.	14 months vs. 15 months
Secondary	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.	15 months vs. 16 months
Secondary	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.	16 months vs. 17 months
Secondary	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.	17 months vs. 18 months
Secondary	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.	18 months vs. 19 months
Secondary	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.	19 months vs. 20 months
Secondary	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.	20 months vs. 21 months
Secondary	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.	21 months vs. 22 months
Secondary	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.	22 months vs. 23 months
Secondary	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.	23 months vs. 24 months