mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness (NCT06426602) | Clinical Trial Compass
By InvitationNot Applicable
mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness
United States40 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Coma
* Bilateral non-response with standard electrophysiological studies
* Medical instability
* Open scalp wound
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically studying patients with disorders of consciousness, could you help me understand whether my family member's current level of consciousness — whether they're in a vegetative state, minimally conscious state, or something else — is what the mindBEAGLE system is designed to assess?
2The trial is measuring how accurately the mindBEAGLE system can classify brain responses and support communication in people with disorders of consciousness — what does that mean practically, and could it change how my loved one's care team understands what they're aware of or able to communicate?
3Because this trial is 'enrolling by invitation only,' what would it take for my family member to be considered, and is there a reason their care team might or might not refer them?
4The study is also measuring how acceptable the mindBEAGLE technology feels to families like ours — what does our involvement actually look like during the sessions, and is there anything emotionally or logistically demanding we should prepare for?
5Since this is listed as Phase NA — meaning it's not a traditional drug trial — what is already known about whether mindBEAGLE is safe to use with someone in my loved one's condition, and are there any risks we should weigh against trying standard assessment approaches instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment
Timeframe: 18 months
2
DOC mindBEAGLE Communication Assessment
Timeframe: 18 months
3
Acceptability of mindBEAGLE treatment by clinical staff.
Timeframe: Within 2 weeks Post-intervention
4
Acceptability of mindBEAGLE treatment by families of DOC patients.