Brain-Computer Interface for Neurodegenerative Disease

Overseen By Jane Huggins, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Katharine Katya Joan Hill

Disqualifiers: No speech device, Epilepsy, Hearing loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new communication device for individuals who have difficulty moving and speaking. The device, called AAC-BCI, enables communication using brain signals instead of direct touch. It targets those who cannot speak well enough to meet daily needs and already use a speech device. Participants need a tech-savvy support person at home to assist with setup and ensure smooth operation. The trial evaluates the device's performance in real-life settings, focusing on ease of use, reliability, and comfort. As an unphased trial, it offers participants the chance to contribute to innovative research that could significantly enhance communication for those with speech difficulties.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this AAC-BCI device is safe for users with minimal movement?

Studies have shown that AAC-BCI devices can help people with severe speech and physical impairments communicate. Research indicates these devices can support communication for individuals with neurodegenerative diseases who have limited movement. However, they might not work well for everyone.

The AAC-BCI device tested in this trial targets people with limited movement who could benefit from technology that aids expression. Although no clear data exists on severe side effects, researchers continue to study the device's safety and effectiveness. Studies suggest the device is generally well-tolerated, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AAC-BCI device is unique because it combines brain-computer interface technology with augmentative and alternative communication tools, offering a new way for individuals with severe movement disabilities to communicate. Unlike traditional communication aids that rely on physical input, this device translates brain signals directly into actions, allowing for hands-free communication. Researchers are excited about its potential to improve user satisfaction, performance, and reliability, making it a promising option for those who find current devices inadequate or challenging to use.

What evidence suggests that the AAC-BCI device is effective for neurodegenerative disease?

Research shows that the AAC-BCI device, used in this trial, can assist people with neurodegenerative diseases who have severe movement difficulties. Studies have demonstrated that this device improves communication by using brain signals to control a computer. Real-world tests have successfully enabled individuals with limited movement to communicate more effectively. Reviews of similar devices highlight their potential to enhance communication for those with severe disabilities. These devices are designed to be reliable and comfortable for home use. ^{2 5 6 7 8}

Who Is on the Research Team?

Katharine J Hill, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

For augmentative and alternative communication, brain-computer interface (AAC-BCI) Users:

Natural speech does not meet daily communication needs requiring the use of a speech generating device

Has been assessed for and currently using a speech generating device as a means of communication

Exclusion Criteria

For AAC-BCI Users:

Does not own or use a speech generating device

I cannot participate in the study during the scheduled times.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Calibration

Initial set-up, calibration, and training sessions with AAC-BCI device, including EEG and logfile data collection

1 week

2 visits (in-person)

Home Use and Monitoring

Participants use the AAC-BCI device at home for at least 10 hours a week, with monthly home visits and weekly follow-up calls for data collection

6 months

Monthly home visits, weekly follow-up calls

Follow-up

Participants complete a survey to rate the overall commercial readiness of the AAC-BCI device

1 week

What Are the Treatments Tested in This Trial?

Interventions

• AAC-BCI device

Trial Overview 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.

How Is the Trial Designed?

Group I: Testing commercial readiness of an AAC-BCI device Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Katharine Katya Joan Hill

Lead Sponsor

Trials

1

Recruited

40+

Kendrea Garand

Lead Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

PRC

Collaborator

Trials

1

Recruited

40+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9374067/

A systematic review of research on augmentative and ... Face stimuli effectively prevent brain-computer interface inefficiency in patients with neurodegenerative disease. Clin. Neurophysiol. 124 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04026581

Real World Testing of a Brain-Computer Interface | ... Individuals with severe communication disabilities and minimal movement impairment. ... Neurodegenerative Diseases. TDP-43 Proteinopathies. Neuromuscular Diseases.

3. withpower.com withpower.com/trial/phase-neurodegenerative-diseases-8-2024-94c75

Brain-Computer Interface for Neurodegenerative Disease This trial is for individuals with neurodegenerative diseases or nervous system disorders who have limited movement and could benefit from technology that helps ...

4. researchgate.net researchgate.net/publication/362305134_A_systematic_review_of_research_on_augmentative_and_alternative_communication_brain-computer_interface_systems_for_individuals_with_disabilities

A systematic review of research on augmentative and ... Augmentative and alternative communication brain-computer interface (AAC-BCI) ... in patients with neurodegenerative disease. Clin. Neurophysiol.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8442856/

Considering Augmentative and Alternative Communication ... Face stimuli effectively prevent brain–computer interface inefficiency in patients with neurodegenerative disease. Clinical Neurophysiology, 124(5), 893–900 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35966988/

A systematic review of research on augmentative and ... Results suggest that AAC-BCI systems show promise for supporting communication for people with SSPI, but they remain ineffective for some individuals.

7. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.952380/full

A systematic review of research on augmentative and ... Face stimuli effectively prevent brain-computer interface inefficiency in patients with neurodegenerative disease. Clin. Neurophysiol. 124 ...

8. ohsu.edu ohsu.edu/university-center-excellence-development-disability/systematic-review-research-aac-brain-computer

Systematic Review of Research on AAC Brain-Computer ... This systematic review shows where things stand with AAC-BCI research for people with disabilities, and what researchers can do better in the future.