mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Disorders of Consciousness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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mindBEAGLE trial participants

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.

Group Type EXPERIMENTAL

mindBEAGLE daily device use

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.