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mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness

StatusEnrolling by Invitation
PhaseNot applicable
SponsorAmy Wagner
Started
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Record History

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  1. Primary completion date changed from estimate of Mar 2026 to Mar 1, 2026v8
  2. Primary completion date: Dec 2025 to Mar 2026
    • Study completion date: Dec 2025 to Dec 2026
    v7
  3. Primary completion date: Jun 2025 to Dec 2025
    • Study completion date: Jul 2025 to Dec 2025
    v6
  4. Start date changed from estimate of Oct 2024 to Oct 1, 2024v5
  5. Enrollment target: 15 to 40v4 Show 4 more changesShow less
    • Start date: Aug 2024 to Oct 2024
    • Trial status: Recruiting to Enrolling by Invitation
    • Eligibility criteria expanded, about 19 words
    • Site details revised at 2 of 2 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2024 to Aug 2024
    • Site details revised at 2 of 2 sites
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06426602
Lead Sponsor Amy Wagner
Collaborators: The Beckwith Institute
Conditions
(from sponsor)		 Disorders of Consciousness
Related terms Coma, Consciousness Disorders, Locked-In Syndrome, Persistent Vegetative State
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov