mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness

Enrolling by invitation · Not applicable

Conditions studied: Disorders of Consciousness

In brief

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 facts

Study ID

NCT06426602

Run by

Amy Wagner

People needed

40

Starts

2024-10-01

Expected to finish

2026-12-01

Last updated by the study team

2026-06-04

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Coma
• Bilateral non-response with standard electrophysiological studies
• Medical instability
• Open scalp wound

Where it is running

• UPMC Center for Assistive Technology — Pittsburgh, Pennsylvania, United States
• UPMC Rehabilitation Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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