Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426602
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-15
First Post:
2024-01-16
Brief Title:
mindBEAGLE Unlocking Functional Communication for Patients With Disorders of Consciousness
Sponsor:
Amy Wagner
Organization:
University of Pittsburgh
Study Overview
Official Title:
Unlocking Functional Communication for Patients With Disorders of Consciousness With Innovative Brain Computer Interface Technology
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 test how effective the mindBEAGLE device is in allowing people who are unconscious due to a brain injury or other condition to communicate using brain waves to answer YesNo questions Participants will wear a cap that will be connected to a computer that measures brain waves wrist bands that vibrate at different strengths and ear phones that create different levels of loud tones and will be asked to associate YesNo answers with the vibrations or tones They will also be asked to think about moving different parts of their body to answer Yes or No The mindBEAGLE device has already been proven effective for this kind of communication in a previous study and the study team would like to trial it on a population of unconscious people who enter the UPMC Rehabilitation Institute to see if patients are able to be trained to use the device as part of their everyday inpatient rehabilitation until they are discharged or until they are able to regain consciousness
Detailed Description:
The teams research reflects an integrated clinical and research team who will characterize and implement an aggressive and innovative approach using brain-computer interface BCI technology for Disorders of Consciousness DoC evaluation prognostication and rehabilitation care The work proposed strives for equity in accessing healthcare systems and technology effectively even among vulnerable individuals with profound levels of disability due to their DoC state
The gold-standard for assessing cognitive capacity among patients with DoC relies on behavioral response observations and neuroimaging modalities However these approaches underestimate patients capabilities The current problem is that without other clinical data rehabilitation teams rely solely on observable behavioral changes in patients awareness of their environment in order to treat and improve communication The projects challenge rests with implementing BCI focused assistive technology that identifies a unique and specific electrophysiological biomarker of cognitive and communication capacities that cannot be tapped using current clinical tools If successful this approach will allow clinical teams to initiate treatment and communication avoiding therapeutic delays arising from traditional methods that require behavioral indicators needed to participate in functional communication
The P300 wave is a positive deflection in the human event-related potential It is most commonly elicited in an oddball paradigm when a subject detects an occasional target stimulus in a regular train of standard stimuli
This project will compare standard awareness training methods used at the UPMC RI Brain Injury program with novel BCI research by using mindBEAGLE a suite of P300 paradigms vibrations sound tones and mental visualization used for cognitive and communication assessment and treatment European studies using the mindBEAGLE system with DoC patients reveal patients cognitive and communication capabilities that impact current functional assessment and influence prognostication and recovery The mindBEAGLE gives additional diagnostic data to enhance clinical neuroscience practice by showing reactions to stimuli that benefit from electroencephalogram EEG P300 use However clinical neuroscience implementation studies have not been conducted Armed with more detailed and accurate assessments from this study the investigators are confident that the clinical teams will be able to offer exciting rehabilitation treatments designed by UPMC RI treatment teams patients and families that leverage the mindBEAGLE interface for functional communication Specifically the EEG-based mindBEAGLE BCI suite will provide a practical platform for cognitive assessment of command following and a communication system for patients with DoC that will allow the research teams to offer more intensive multidimensional rehabilitation treatments that meet the UPMC ideal of Life Changing Medicine
The gold-standard for assessing cognitive capacity among patients with DoC relies on behavioral response observations and neuroimaging modalities However these approaches underestimate patients capabilities The current problem is that without other clinical data rehabilitation teams rely solely on observable behavioral changes in patients awareness of their environment in order to treat and improve communication The projects challenge rests with implementing BCI focused assistive technology that identifies a unique and specific electrophysiological biomarker of cognitive and communication capacities that cannot be tapped using current clinical tools If successful this approach will allow clinical teams to initiate treatment and communication avoiding therapeutic delays arising from traditional methods that require behavioral indicators needed to participate in functional communication
The P300 wave is a positive deflection in the human event-related potential It is most commonly elicited in an oddball paradigm when a subject detects an occasional target stimulus in a regular train of standard stimuli
This project will compare standard awareness training methods used at the UPMC RI Brain Injury program with novel BCI research by using mindBEAGLE a suite of P300 paradigms vibrations sound tones and mental visualization used for cognitive and communication assessment and treatment European studies using the mindBEAGLE system with DoC patients reveal patients cognitive and communication capabilities that impact current functional assessment and influence prognostication and recovery The mindBEAGLE gives additional diagnostic data to enhance clinical neuroscience practice by showing reactions to stimuli that benefit from electroencephalogram EEG P300 use However clinical neuroscience implementation studies have not been conducted Armed with more detailed and accurate assessments from this study the investigators are confident that the clinical teams will be able to offer exciting rehabilitation treatments designed by UPMC RI treatment teams patients and families that leverage the mindBEAGLE interface for functional communication Specifically the EEG-based mindBEAGLE BCI suite will provide a practical platform for cognitive assessment of command following and a communication system for patients with DoC that will allow the research teams to offer more intensive multidimensional rehabilitation treatments that meet the UPMC ideal of Life Changing Medicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BECKW12863 | OTHER_GRANT | UPMC Beckwith Institute | None |