Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521736
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Brain-computer Interface Commercial Readiness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Compatibility Between Brain-Computer Interface and High Efficiency Augmentative and Alternative Communication Systems Commercial Readiness
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface AAC-BCI device for people with minimal movement who benefit from expressive communication technology Our clinical trial focuses on up to 8 AAC-BCI users but involves a team of support participants with different roles an industry partners consultant a speech language pathologist SLP and the users in-home support person Patient and team reported outcome measures data will be collected on usage performance reliability and comfort along with performance data of using the AAC-BCI device in the home
Detailed Description:
Our clinical trial focuses on 8 Alternative Communication Brain-Computer Interface AAC-BCI users but involves a team of support participants with different roles an industry partners consultant a speech language pathologist SLP and the users in-home support person The AAC-BCI user and support person will be recruited from the SLPs clinic and screened to confirm that the individuals meet the inclusion and exclusion criteria before enrollment The investigators intend to recruit users with a perceived need for Brain-Computer Interface BCI access ex eye gaze access is deteriorating unable to determine another access method The investigators expect that our user participants will be in late-stage amyotrophic lateral sclerosis ALS diagnosed with a brainstem stroke other degenerative neurologic disorder such as Kennedy disease or have severe quadriplegic cerebral palsy The support person will be screened to ensure they are comfortable with technology learning innovative technology and are available to set-up the AAC-BCI daily at the users request The home must have internet A total of 8 enrolled users means that the investigators will have up to 16 team members supported by a consultant All clinical trial activity will occur in the home Once consented and enrolled the first training session with set-up and calibration will occur with the SLP and PRC consultant The support person must be present A second training session with a calibration check and use and training on electroencephalogram EEG and logfile data collection will occur within one week The following baseline data will be collected by the consultant and SLP 1 A functional rating scale 2 copy spell task 15 minutes 3 free spell task 15 minutes National Aeronautics and Space Administration NASA Task Load Index TLX
The roles of the team members are as follows
Industry partners consultant Participate in initial and follow-up AAC-BCI training sessions provide technology support as needed via phone call virtual meeting or home visit Complete required inventory and data forms Conduct monthly home visits
Speech Language Pathologist SLP Participate in initial and follow-up AAC-BCI training sessions Provide treatment and standard of clinical care as needed via phone call virtual meeting or home visit Complete required data forms related to clinical care and support Complete inventory and data forms
AAC-BCI User Participate in initial set-up calibration and training sessions Use at home at least 10 hours a week with EEG activity Use system for daily communication during time they are wearing it Participate in monthly home visit with SLP and weekly follow-up call with researcher to collect data Complete surveys on effectiveness when trying to communicate and effectiveness when not trying to communicate
Support Person Participate in initial set-up calibration and training sessions Agree to set-up for AAC-BCI user in the home so that the user is wearing the headgear and the EEG electrodes are active for at least 10 hours a week Complete recommended cleaning and storage of equipment after use Participate at monthly visits with consultant contacts with the SLP and weekly call with researchers Complete data collection forms
At the end of the 6-month study participants will complete a Qualtrics survey to rate the overall commercial readiness of the AAC-BCI device along with rating the AAC-BCI device on satisfaction performance reliability and comfort
The roles of the team members are as follows
Industry partners consultant Participate in initial and follow-up AAC-BCI training sessions provide technology support as needed via phone call virtual meeting or home visit Complete required inventory and data forms Conduct monthly home visits
Speech Language Pathologist SLP Participate in initial and follow-up AAC-BCI training sessions Provide treatment and standard of clinical care as needed via phone call virtual meeting or home visit Complete required data forms related to clinical care and support Complete inventory and data forms
AAC-BCI User Participate in initial set-up calibration and training sessions Use at home at least 10 hours a week with EEG activity Use system for daily communication during time they are wearing it Participate in monthly home visit with SLP and weekly follow-up call with researcher to collect data Complete surveys on effectiveness when trying to communicate and effectiveness when not trying to communicate
Support Person Participate in initial set-up calibration and training sessions Agree to set-up for AAC-BCI user in the home so that the user is wearing the headgear and the EEG electrodes are active for at least 10 hours a week Complete recommended cleaning and storage of equipment after use Participate at monthly visits with consultant contacts with the SLP and weekly call with researchers Complete data collection forms
At the end of the 6-month study participants will complete a Qualtrics survey to rate the overall commercial readiness of the AAC-BCI device along with rating the AAC-BCI device on satisfaction performance reliability and comfort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None