An interventional study of mindBEAGLE daily device use in Disorders of Consciousness, sponsored by Amy Wagner. Enrolling by invitation at 2 sites in United States. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Amy Wagner · Not applicable, Interventional, and Supportive care
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.
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.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 40 is below the median of 47 across 191 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →This is the only study on the registry with Amy Wagner as lead sponsor.
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Exclusion Criteria:
Patients identified as "disorders of consciousness" admitted to UPMC Rehabilitation Institute will be considered for the trial. As patients will not be able to communicate, health care proxy will provide consent. Participants will undergo 3 trials across 5 days within a 10-day period (2-3 hours each ) to assess if they are responding to the device.
Device: mindBEAGLE 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.
Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment
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.
Time frame: 18 months
DOC mindBEAGLE Communication Assessment
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.
Time frame: 18 months
Acceptability of mindBEAGLE treatment by clinical staff.
Clinicians agree that mindBEAGLE is feasible to implement with DOC patients in the inpatient setting.
Time frame: Within 2 weeks Post-intervention
Acceptability of mindBEAGLE treatment by families of DOC patients.
Family/Caregivers of DOC patient agree that the mindBEAGLE was beneficial.
Time frame: Within 2 weeks Post-intervention
Plan to share: Yes — It is possible that the investigators may use the information obtained from this study in other future research studies. All information disseminated to outside collaborators or entities will be done in a de-identified manner so as to mitigate a breach of confidentiality and protect PHI/PII. Data will be coded using unique identifying numbers that do not contain PII. Any links to PII will be kept locally but will not be disseminated to outside collaborators. Any data shared with outside institutions or collaborators will be conducted under the guidelines of an approved data use agreement between the University of Pittsburgh and the collaborating entity. This includes any plans to publish published peer-reviewed manuscripts.
Ran from Oct 2024 to primary completion in Mar 2026, 17 months.
Of 89 non-industry interventional studies with no phase under Consciousness Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's 17 months is below that.
Counting every sponsor, half of 94 studies reached it within 19 months; a quarter within 8 and three quarters within 52.
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