Disorders of Consciousness
Conditions
Keywords
Coma, Locked-in syndrome, Vegetative state, Unresponsive wakefulness syndrome, Minimally conscious state
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 Yes/No 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 Yes/No 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 team's 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 project's 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.
Interventions
DEVICEmindBEAGLE daily device use
If participants are considered responsive, they will continue to use the device daily for the remainder of their stay at inpatient rehab, or until they regain consciousness.
Sponsors
Amy Wagner
The Beckwith Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single arm Phase 2 experimental device efficacy clinical trial To facilitate interpretation of the data generated with this DoC cohort, we will also recruit subjects with locked in syndrome (LIS) receiving care from one or more of our collaborative team and who are not able to communicate via traditional methods but have cognition intact. These patients will follow the same inclusion criteria with the exception of DoC status.
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 16-65 * Medically able to tolerate Disorders of Consciousness (DoC) rehabilitation program as determined by UPMC Physicians * Locked in Syndrome (LIS) patients who show clinical evidence of intact cognition via some form of alternative communication methods * Clinically assessed capacity for functional improvement in the rehabilitation environment * Measuring improvements with pharmacological stimulation (using JFK Coma Recovery Scale) * Electrophysiological prognostic testing confirming brain activity.
Exclusion criteria
* Coma * Bilateral non-response with standard electrophysiological studies * Medical instability * Open scalp wound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment | 18 months | The ability to answer Yes/No questions at over above 40% accuracy using 1 of the following paradigms: 1. auditory evoked potentials; 2. vibro-tactile stimulation with 2 tactors; 3. vibro-tactile stimulation with 3 tactors; 4. vibro-tactile stimulation with 7 tactors; 5. motor imagery. |
| DOC mindBEAGLE Communication Assessment | 18 months | Among DOC patients who pass initial classification assessment: ability to communicate yes/no questions at or above 40% accuracy with one of the two P300 paradigms. mindBEAGLE P300 paradigm #1 1. Baseline - No response to yes/no questions 2. Change in baseline - Response to yes/no questions using mindBEAGLE mindBEAGLE P300 paradigm #2 1. Baseline - 0% accuracy on yes/no questions 2. Change in baseline - 60% or higher in response to yes/no questions. |
| Acceptability of mindBEAGLE treatment by clinical staff. | Within 2 weeks Post-intervention | Clinicians agree that mindBEAGLE is feasible to implement with DOC patients in the inpatient setting. |
| Acceptability of mindBEAGLE treatment by families of DOC patients. | Within 2 weeks Post-intervention | Family/Caregivers of DOC patient agree that the mindBEAGLE was beneficial. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy Wagner, M.D.
University of Pittsburgh
PRINCIPAL_INVESTIGATORKatherine Hill, Ph.D.
University of Pittsburgh
Outcome results
None listed