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NCT06426602

mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness

Enrolling by Invitation
NAAges 16–65InterventionalSupportive care
Amy Wagner
~40 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:mindBEAGLE daily device use

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment
Measured over 18 months
+3 more outcomes measured

Conditions

Disorders of Consciousness

Explore related trials

Consciousness DisordersLocked-In StateMinimally conscious stateUnresponsive wakefulness syndromeVegetative State

Where it's being run

2 sites across 1 states
Pennsylvania2

Study leadership

  • Amy Wagner, M.D. · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
  • Katherine Hill, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment18 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 Assessment18 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.