mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness

NCT06426602 | Enrolling By Invitation FDA Device

• 2 other identifiers: STUDY23080022BECKW/12863
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Disorders of Consciousness

Keywords

Coma; Locked-in syndrome; Vegetative state; Unresponsive wakefulness syndrome; Minimally conscious state

Outcome Measures

Primary Outcomes (4)

• Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment

  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.

  18 months

• DOC mindBEAGLE Communication Assessment

  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.

  18 months

• Acceptability of mindBEAGLE treatment by clinical staff.

  Clinicians agree that mindBEAGLE is feasible to implement with DOC patients in the inpatient setting.

  Within 2 weeks Post-intervention

• Acceptability of mindBEAGLE treatment by families of DOC patients.

  Family/Caregivers of DOC patient agree that the mindBEAGLE was beneficial.

  Within 2 weeks Post-intervention

Study Arms (1)

mindBEAGLE trial participants

EXPERIMENTAL

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.

Device: mindBEAGLE daily device use

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.

mindBEAGLE trial participants

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Amy Wagner: lead
• The Beckwith Institute: collaborator

Study Sites (2)

UPMC Center for Assistive Technology

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Rehabilitation Institute

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (4)

• Kondziella D, Amiri M, Othman MH, Beghi E, Bodien YG, Citerio G, Giacino JT, Mayer SA, Lawson TN, Menon DK, Rass V, Sharshar T, Stevens RD, Tinti L, Vespa P, McNett M, Venkatasubba Rao CP, Helbok R; Curing Coma Campaign Collaborators. Incidence and prevalence of coma in the UK and the USA. Brain Commun. 2022 Sep 1;4(5):fcac188. doi: 10.1093/braincomms/fcac188. eCollection 2022.

  PMID: 36132425 BACKGROUND

• Godbolt AK, Deboussard CN, Stenberg M, Lindgren M, Ulfarsson T, Borg J. Disorders of consciousness after severe traumatic brain injury: a Swedish-Icelandic study of incidence, outcomes and implications for optimizing care pathways. J Rehabil Med. 2013 Sep;45(8):741-8. doi: 10.2340/16501977-1167.

  PMID: 24002309 BACKGROUND

• Mainali S, Aiyagari V, Alexander S, Bodien Y, Boerwinkle V, Boly M, Brown E, Brown J, Claassen J, Edlow BL, Fink EL, Fins JJ, Foreman B, Frontera J, Geocadin RG, Giacino J, Gilmore EJ, Gosseries O, Hammond F, Helbok R, Claude Hemphill J, Hirsch K, Kim K, Laureys S, Lewis A, Ling G, Livesay SL, McCredie V, McNett M, Menon D, Molteni E, Olson D, O'Phelan K, Park S, Polizzotto L, Javier Provencio J, Puybasset L, Venkatasubba Rao CP, Robertson C, Rohaut B, Rubin M, Sharshar T, Shutter L, Sampaio Silva G, Smith W, Stevens RD, Thibaut A, Vespa P, Wagner AK, Ziai WC, Zink E, I Suarez J; Curing Coma Campaign collaborators. Proceedings of the Second Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness. Neurocrit Care. 2022 Aug;37(1):326-350. doi: 10.1007/s12028-022-01505-3. Epub 2022 May 10.

  PMID: 35534661 BACKGROUND

• Torres-Saavedra PA, Winter KA. An Overview of Phase 2 Clinical Trial Designs. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):22-29. doi: 10.1016/j.ijrobp.2021.07.1700. Epub 2021 Aug 4.

  PMID: 34363901 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Coma; Locked-In Syndrome; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Unconsciousness; Quadriplegia; Paralysis; Neuromuscular Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Amy Wagner, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Katherine Hill, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: May 23, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)