mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness

Conditions

• Disorders of Consciousness

Eligibility Criteria

Sex

ALL

Age

16 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• mindBEAGLE daily device use — 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.

Study Details

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.

Key Dates

Start date

Oct 1, 2024

Status verified

Jun 2026

Primary completion

Mar 1, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: 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.

Primary Outcome Measure

Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment [ Time Frame: 18 months ]

Locations (2)

Find similar trials in Pittsburgh, PA

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