mindBEAGLE Device for Consciousness Disorders

Recruiting 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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the mindBEAGLE treatment for consciousness disorders?

Research suggests that brain-computer interfaces, like those used in mindBEAGLE, can help detect signs of consciousness in patients with disorders of consciousness by identifying responses to commands and enabling communication. ^{1 2 3 4 5}

Is the mindBEAGLE device safe for use in humans?

The safety of brain-computer interfaces (BCIs), like the mindBEAGLE device, is still being studied, but research on similar devices shows that identifying risks such as short and long-term safety, cognitive effects, and privacy concerns is important. While there is ongoing research, the safety of these devices in humans is not yet fully known. ^{6 7 8 9 10}

How is the mindBEAGLE treatment different from other treatments for consciousness disorders?

The mindBEAGLE treatment is unique because it uses a brain-computer interface (BCI) to detect awareness in patients with consciousness disorders, even when they can't respond behaviorally. This approach is different from traditional methods that rely on observing patient behavior, making it potentially more accurate for diagnosing and communicating with patients who have limited responsiveness. ^{2 3 11 12 13}

Research Team

Katherine Hill, Ph.D.

Principal Investigator

University of Pittsburgh

Amy Wagner, M.D.

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cortical responses to auditory stimulation predict the prognosis of patients with disorders of consciousness. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Probing command following in patients with disorders of consciousness using a brain-computer interface. [2012]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Brain-computer interfaces for patients with disorders of consciousness. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Detection of response to command using voluntary control of breathing in disorders of consciousness. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment Trials in Disorders of Consciousness: Challenges and Future Directions. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

The RNS System: brain-responsive neurostimulation for the treatment of epilepsy. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Stimulation of vagus nerve for patients with disorders of consciousness: a systematic review. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. [2023]

11. England pubmed.ncbi.nlm.nih.gov

A gaze-independent audiovisual brain-computer Interface for detecting awareness of patients with disorders of consciousness. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Psychometric properties of the disorders of consciousness scale. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Detection of mental imagery and attempted movements in patients with disorders of consciousness using EEG. [2020]