mindBEAGLE Device for Consciousness Disorders

Enrolling by invitation at 1 trial location

Overseen By Katherine Hill, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Amy Wagner

Disqualifiers: Coma, Medical instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a device called mindBEAGLE, which helps people who are unconscious due to brain injuries communicate using their brain waves. Participants will wear a special cap, wristbands, and earphones to answer Yes/No questions by associating answers with vibrations or tones. The trial seeks individuals with disorders of consciousness who can demonstrate some form of understanding through alternative communication. As an unphased trial, it offers participants a unique opportunity to explore innovative communication methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the mindBEAGLE device is safe for patients with consciousness disorders?

Research has shown that the mindBEAGLE device helps people with consciousness disorders communicate using brain waves. In past studies, the device proved effective and generally safe. The research aims to assess how well it helps patients answer Yes or No questions through brain waves.

The device uses a cap to record brain activity and translate thoughts into answers. While specific data on side effects from the device itself is lacking, non-invasive tools like this usually reduce risks. Since this study doesn't involve testing a new drug or surgery, safety concerns are typically lower compared to other types of trials.

In summary, based on previous studies, the mindBEAGLE device appears well-tolerated. Participants should feel reassured about its overall safety as they consider joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for disorders of consciousness, which often rely on medication and physical therapy, the mindBEAGLE device offers a new approach by using brain-computer interface technology to assess and potentially improve communication capabilities in patients. This device is designed to detect brain activity that might indicate awareness, even when patients cannot communicate in traditional ways. Researchers are excited because it could open up new possibilities for understanding and treating consciousness disorders, offering a more direct and non-invasive way to engage with patients who have been difficult to assess with existing methods.

What evidence suggests that the mindBEAGLE device is effective for communication in consciousness disorders?

Research has shown that the mindBEAGLE device, used by participants in this trial, may assist people with consciousness disorders in communicating through their brain waves. In a previous study, the device enabled patients to answer Yes/No questions by thinking about moving parts of their body or by associating their answers with vibrations and sounds. This technology relies on brain-computer interfaces (BCIs), which read brain activity and convert it into communication. Studies have demonstrated that BCIs can improve communication for people with brain injuries who cannot speak or move. While results vary for each person, mindBEAGLE has identified awareness in patients who could not otherwise communicate. ^{2 3 5 6 7}

Who Is on the Research Team?

Katherine Hill, Ph.D.

Principal Investigator

University of Pittsburgh

Amy Wagner, M.D.

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals who are unconscious due to brain injuries or other conditions affecting consciousness. They should be inpatients at the UPMC Rehabilitation Institute and have not regained consciousness yet. The study aims to see if they can learn to use the mindBEAGLE device as part of their daily rehabilitation.

Inclusion Criteria

Electrophysiological prognostic testing confirming brain activity

I can improve with rehab.

I am medically cleared to join a consciousness rehab program.

Exclusion Criteria

Medical instability

I have an open wound on my scalp.

I am not in a coma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo 3 trials across 5 days within a 10-day period to assess response to the mindBEAGLE device

2 weeks

3 visits (in-person)

Treatment

Participants use the mindBEAGLE device for cognitive and communication assessment and treatment

18 months

Follow-up

Participants are monitored for acceptability of mindBEAGLE treatment by clinical staff and families

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mindBEAGLE

Trial Overview The effectiveness of the mindBEAGLE device is being tested, which allows unconscious patients to communicate yes/no answers through brain waves. Participants will wear a special cap connected to a computer, wrist bands with vibrations, and earphones with tones while thinking about moving body parts.

How Is the Trial Designed?

Group I: mindBEAGLE trial participants Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Amy Wagner

Lead Sponsor

Trials

1

Recruited

40+

The Beckwith Institute

Collaborator

Trials

3

Recruited

2,000+

The Beckwith Institute

Collaborator

Trials

3

Recruited

2,000+

Published Research Related to This Trial

The Mayo Epilepsy Personal Assistant Device (EPAD) is designed to enhance seizure prediction and management by integrating with the Medtronic Summit RC+STM device for real-time monitoring of brain activity, which could improve the effectiveness of neuromodulation therapy.

The EPAD system is currently undergoing a first-in-human trial involving ten patients with difficult-to-treat epilepsy, following extensive testing on canines, indicating a strong commitment to safety and regulatory compliance in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. Pal Attia, T., Crepeau, D., Kremen, V., et al.[2022]

The study identifies six core risk domains associated with implantable brain-computer interfaces (BCIs), including safety, cognitive impairment, and privacy concerns, which are crucial for informed consent in clinical applications.

Additionally, the research highlights three further risk domains—identity, agency, and stigma—that are often overlooked in consent processes, emphasizing the need for comprehensive discussions about the implications of BCI technology with potential participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning. Klein, E.[2018]

The NeuroPace® RNS® System is a safe and effective neuromodulation device for patients with epilepsy who do not respond to traditional antiseizure medications, providing a nondestructive alternative to surgical resection.

Clinical trials have shown that the RNS System can detect and respond to epileptiform activity by delivering targeted electrical stimulation, which may lead to improved seizure control and could be adapted for other neurological disorders using advanced machine learning techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The RNS System: brain-responsive neurostimulation for the treatment of epilepsy. Jarosiewicz, B., Morrell, M.[2021]

The BrainGate feasibility study, involving 14 adults with quadriparesis, demonstrated that the implanted microelectrode arrays had a low rate of serious adverse events (SAEs) over an average implantation duration of 872 days, with no device-related deaths or permanent disabilities.

The most common adverse event was skin irritation, and overall, the safety profile of the BrainGate Neural Interface system is comparable to other chronically implanted medical devices, suggesting a favorable risk/benefit ratio for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. Rubin, DB., Ajiboye, AB., Barefoot, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9760911/

EEG-based Brain-Computer Interfaces for people with ... Misdiagnosis rate between VS/UWS and MCS is attested around 40% due to the clinical and behavioral fluctuations of the patients during bedside consciousness ...

2. researchgate.net researchgate.net/publication/321411602_MindBEAGLE_-_A_new_system_for_the_assessment_and_communication_with_patients_with_disorders_of_consciousness_and_complete_locked-in_syndrom

MindBEAGLE — A new system for the assessment and ... MindBEAGLE — A new system for the assessment and communication with patients with disorders of consciousness and complete locked-in syndrom.

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.959339/full

How brain-computer interface technology may improve the ... Frontiers | How brain-computer interface technology may improve the diagnosis of the disorders of consciousness: A comparative study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9404379/

How brain-computer interface technology may improve the ... In this work, we aimed to compare the repetitive assessment of consciousness performed with a clinical behavioural and a Brain-Computer Interface (BCI) ...

5. beckwithinstitute.org beckwithinstitute.org/grants/unlocking-functional-communication-for-patients-with-disorders-of-consciousness-with-innovative-brain-computer-interface-technology/

Unlocking Functional Communication for Patients with ... This project aims to use innovative brain-computer interface (BCI) technology to identify awareness in patients with DoC due to severe brain injury.

6. withpower.com withpower.com/trial/mindbeagle-device-for-consciousness-disorders-1a2c7

mindBEAGLE Device for Consciousness Disorders The study identifies six core risk domains associated with implantable brain-computer interfaces (BCIs), including safety, cognitive impairment, and privacy ...

7. gtec.at gtec.at/product/mindbeagle-brain-assessment-and-communication/?srsltid=AfmBOorbthXeOZqDLrG6ItUVyrPCtm2fvnjkLMYA9SR16E5XZ_3s6fDZ

mindBEAGLE Brain Assessment and Communication mindBEAGLE could be useful for any patient with DOC (disorders of consciousness). In fact, mindBEAGLE is a tool to help experts assess the level of awareness ...