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Behavioural Intervention
Brain-Computer Interface for Neurodegenerative Disease
N/A
Waitlist Available
Led By Katharine J Hill, PhD
Research Sponsored by Katharine Katya Joan Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is 18 years or older
Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
Must not have
History of photosensitive epilepsy
History of uncorrectable hearing loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test a new communication device for people with limited movement. The study will involve 8 users and a team of support participants including a consultant, a speech-language pathologist, and an
Who is the study for?
This trial is for individuals with neurodegenerative diseases or nervous system disorders who have limited movement and could benefit from technology that helps them communicate. Participants will use an AAC-BCI device at home, supported by a team including a consultant, speech therapist, and in-home support person.
What is being tested?
The study tests the readiness of an AAC-BCI device for market release by assessing its usage, performance, reliability, and comfort when used by patients in their homes. It involves both patient feedback and objective performance data collection.
What are the potential side effects?
Since this trial involves using a communication assistance device rather than medication or invasive procedures, traditional side effects are not expected. However, users may experience discomfort or fatigue from using the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My condition limits my ability to use a keyboard or communication device.
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I am 14 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures triggered by flashing lights.
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I have permanent hearing loss that cannot be fixed.
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I have had open sores on my scalp.
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I do not speak English.
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I cannot attend training sessions at home.
Select...
I do not speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Commercial readiness of augmentative and alternative communication brain-computer interface (AAC-BCI) system.
Secondary study objectives
Alternative Communication Brain-Computer Interface (AAC-BCI) system comfort
Alternative Communication Brain-Computer Interface (AAC-BCI) system performance
Alternative Communication Brain-Computer Interface (AAC-BCI) system reliability
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Testing commercial readiness of an AAC-BCI deviceExperimental Treatment1 Intervention
Participants with severe movement disabilities will use the augmentative and alternative communication, brain-computer interface (AAC-BCI) device at least 10 hours a week in their homes receiving supported from a caregiver, speech language pathologist and consultant and rate the intervention on user satisfaction, performance, reliability, comfort and overall readiness for commercialization.
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Who is running the clinical trial?
Katharine Katya Joan HillLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
348 Previous Clinical Trials
180,758 Total Patients Enrolled
PRCUNKNOWN
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