Disorders of ConsciousnessNCT06426602
mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness
A study testing mindBEAGLE daily device use in people with Disorders of Consciousness, run by Amy Wagner at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- mindBEAGLE daily device use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Coma
- Bilateral non-response with standard electrophysiological studies
- Medical instability
- Open scalp wound
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
UPMC Center for Assistive Technology
Pittsburgh, Pennsylvania, 15213
UPMC Rehabilitation Institute
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Unlocking Functional Communication for Patients With Disorders of Consciousness With Innovative Brain Computer Interface Technology
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.
Read the detailed description
The team's research reflects an integrated clinical and research team who will characterize and implement an aggressive and innovative approach using brain-computer interface (BCI) technology for Disorders of Consciousness (DoC) evaluation, prognostication, and rehabilitation care. The work proposed strives for equity in accessing healthcare systems and technology effectively, even among vulnerable individuals with profound levels of disability due to their DoC state.
The "gold-standard" for assessing cognitive capacity among patients with DoC relies on behavioral response observations and neuroimaging modalities. However, these approaches underestimate patients' capabilities. The current problem is that without other clinical data, rehabilitation teams rely solely on observable behavioral changes in patients' awareness of their environment in order to treat and improve communication. The project's challenge rests with implementing BCI focused assistive technology that identifies a unique and specific electrophysiological biomarker of cognitive and communication capacities that cannot be tapped using current clinical tools. If successful, this approach will allow clinical teams to initiate treatment and communication, avoiding therapeutic delays arising from traditional methods that require behavioral indicators needed to participate in functional communication.
The P300 wave is a positive deflection in the human event-related potential. It is most commonly elicited in an "oddball" paradigm when a subject detects an occasional "target" stimulus in a regular train of standard stimuli.
This project will compare standard awareness training methods used at the UPMC RI Brain Injury program with novel BCI research by using mindBEAGLE, a suite of P300 paradigms (vibrations, sound tones, and mental visualization) used for cognitive and communication assessment and treatment. European studies using the mindBEAGLE system with DoC patients reveal patients' cognitive and communication capabilities that impact current functional assessment and influence prognostication and recovery. The mindBEAGLE gives additional diagnostic data to enhance clinical neuroscience practice by showing reactions to stimuli that benefit from electroencephalogram (EEG) P300 use. However, clinical neuroscience implementation studies have not been conducted. Armed with more detailed and accurate assessments from this study, the investigators are confident that the clinical teams will be able to offer exciting rehabilitation treatments designed by UPMC RI treatment teams, patients, and families that leverage the mindBEAGLE interface for functional communication. Specifically, the EEG-based mindBEAGLE BCI suite will provide a practical platform for cognitive assessment of command following and a communication system for patients with DoC that will allow the research teams to offer more intensive, multidimensional rehabilitation treatments that meet the UPMC ideal of Life Changing Medicine.
- Conditions
- Disorders of Consciousness
- Being tested
- mindBEAGLE daily device use
- Keywords
- Coma, Locked-in syndrome, Vegetative state, Unresponsive wakefulness syndrome, Minimally conscious state
- Medical subject headings
- Consciousness Disorders, Coma, Locked-In Syndrome, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindBEAGLE daily device useDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: mindBEAGLE daily device use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- auditory evoked potentials;
- vibro-tactile stimulation with 2 tactors;
- vibro-tactile stimulation with 3 tactors;
- vibro-tactile stimulation with 7 tactors;
- motor imagery.
Measured: 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
- Baseline - No response to yes/no questions
- Change in baseline - Response to yes/no questions using mindBEAGLE mindBEAGLE P300 paradigm #2
- Baseline - 0% accuracy on yes/no questions
- Change in baseline - 60% or higher in response to yes/no questions.
Measured: 18 months
Acceptability of mindBEAGLE treatment by clinical staff.
Clinicians agree that mindBEAGLE is feasible to implement with DOC patients in the inpatient setting.
Measured: 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.
Measured: Within 2 weeks Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Oct 2024
- Primary completion1 Mar 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amy Wagner
- Sponsor type
- University, hospital or other
- Collaborators
- The Beckwith Institute
- Responsible party
- Sponsor-investigator, Amy Wagner, University of Pittsburgh
- Investigators
- Amy Wagner, M.D., Principal investigator, University of PittsburghKatherine Hill, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426602
- Sponsor's protocol ID
- STUDY23080022
- Other IDs
- BECKW/12863
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: It is possible that the investigators may use the information obtained from this study in other future research studies. All information disseminated to outside collaborators or entities will be done in a de-identified manner so as to mitigate a breach of confidentiality and protect PHI/PII. Data will be coded using unique identifying numbers that do not contain PII. Any links to PII will be kept locally but will not be disseminated to outside collaborators. Any data shared with outside institutions or collaborators will be conducted under the guidelines of an approved data use agreement between the University of Pittsburgh and the collaborating entity. This includes any plans to publish published peer-reviewed manuscripts.
Publications
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.
PubMed 36132425Godbolt 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.
PubMed 24002309Mainali 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.
PubMed 35534661Torres-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.
PubMed 34363901
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unlocking Functional Communication for Patients With Disorders of Consciousness With Innovative Brain Computer Interface Technology
- ClinicalTrials.gov ID
- NCT06426602
- Acronym / sponsor ID
- STUDY23080022
- Conditions
- Disorders of Consciousness
- Keywords
- Coma, Locked-in syndrome, Vegetative state, Unresponsive wakefulness syndrome, Minimally conscious state
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amy WagnerUniversity, hospital or other
- Collaborators
- The Beckwith Institute
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The team's research reflects an integrated clinical and research team who will characterize and implement an aggressive and innovative approach using brain-computer interface (BCI) technology for Disorders of Consciousness (DoC) evaluation, prognostication, and rehabilitation care. The work proposed strives for equity in accessing healthcare systems and technology effectively, even among vulnerable individuals with profound levels of disability due to their DoC state.
The "gold-standard" for assessing cognitive capacity among patients with DoC relies on behavioral response observations and neuroimaging modalities. However, these approaches underestimate patients' capabilities. The current problem is that without other clinical data, rehabilitation teams rely solely on observable behavioral changes in patients' awareness of their environment in order to treat and improve communication. The project's challenge rests with implementing BCI focused assistive technology that identifies a unique and specific electrophysiological biomarker of cognitive and communication capacities that cannot be tapped using current clinical tools. If successful, this approach will allow clinical teams to initiate treatment and communication, avoiding therapeutic delays arising from traditional methods that require behavioral indicators needed to participate in functional communication.
The P300 wave is a positive deflection in the human event-related potential. It is most commonly elicited in an "oddball" paradigm when a subject detects an occasional "target" stimulus in a regular train of standard stimuli.
This project will compare standard awareness training methods used at the UPMC RI Brain Injury program with novel BCI research by using mindBEAGLE, a suite of P300 paradigms (vibrations, sound tones, and mental visualization) used for cognitive and communication assessment and treatment. European studies using the mindBEAGLE system with DoC patients reveal patients' cognitive and communication capabilities that impact current functional assessment and influence prognostication and recovery. The mindBEAGLE gives additional diagnostic data to enhance clinical neuroscience practice by showing reactions to stimuli that benefit from electroencephalogram (EEG) P300 use. However, clinical neuroscience implementation studies have not been conducted. Armed with more detailed and accurate assessments from this study, the investigators are confident that the clinical teams will be able to offer exciting rehabilitation treatments designed by UPMC RI treatment teams, patients, and families that leverage the mindBEAGLE interface for functional communication. Specifically, the EEG-based mindBEAGLE BCI suite will provide a practical platform for cognitive assessment of command following and a communication system for patients with DoC that will allow the research teams to offer more intensive, multidimensional rehabilitation treatments that meet the UPMC ideal of Life Changing Medicine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| mindBEAGLE trial participants | Experimental | Device: mindBEAGLE daily device usePatients 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- Coma
- Bilateral non-response with standard electrophysiological studies
- Medical instability
- Open scalp wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindBEAGLE daily device useIf 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. | Device | mindBEAGLE trial participants |
Primary outcome
Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment
Time frame: 18 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 Assessment
Time frame: 18 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.
Time frame: 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.
Time frame: Within 2 weeks Post-intervention
Family/Caregivers of DOC patient agree that the mindBEAGLE was beneficial.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 36132425Kondziella 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.
- Background: PubMed 24002309Godbolt 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.
- Background: PubMed 35534661Mainali 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.
- Background: PubMed 34363901Torres-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.
- Individual participant dataSharing planned: Yes. It is possible that the investigators may use the information obtained from this study in other future research studies. All information disseminated to outside collaborators or entities will be done in a de-identified manner so as to mitigate a breach of confidentiality and protect PHI/PII. Data will be coded using unique identifying numbers that do not contain PII. Any links to PII will be kept locally but will not be disseminated to outside collaborators. Any data shared with outside institutions or collaborators will be conducted under the guidelines of an approved data use agreement between the University of Pittsburgh and the collaborating entity. This includes any plans to publish published peer-reviewed manuscripts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Wagner, M.D. principal investigator
University of Pittsburgh
Katherine Hill, Ph.D. principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindBEAGLE daily device use in people with Disorders of Consciousness, run by Amy Wagner at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06426602, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.