Brain-Computer Interface Device for Severe Neurological Disorders

(BRAVO Trial)

Overseen By Adelyn Tu-Chan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Karunesh Ganguly

Disqualifiers: Dementia, Active depression, Substance abuse, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the PMT/Blackrock Combination Device, which uses brain signals to help people with severe neurological disorders control devices for movement and speech. The focus is on conditions like stroke, ALS, or spinal cord injuries, where individuals have lost independence and can't perform daily tasks. The trial seeks participants who have serious difficulty using their arms due to these conditions and live within two hours of UCSF.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform lives.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this brain-computer interface device is safe for use in severe neurological disorders?

Research has shown that the PMT/Blackrock Combination Device has been tested for safety and effectiveness in controlling devices using brain signals. The device employs a method called electrocorticography (ECoG), which involves placing sensors on the brain's surface to detect electrical activity.

Previous studies have found that the device remains safe and reliable over time. Specifically, the NeuroPort Electrode, a component of this system, is designed for safe and effective long-term use. This indicates that the device functions well without causing major issues for users over extended periods.

While specific details about side effects are not provided, available information suggests that the treatment is generally well-tolerated. This is encouraging for those considering participation in a clinical trial with this device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PMT/Blackrock Combination Device because it offers a groundbreaking approach for severe neurological disorders. Unlike traditional treatments that rely on medications or physical therapies, this device uses an electrocorticography-based brain-computer interface to directly connect the brain with external devices. This novel mechanism allows for real-time communication between the brain and technology, which has the potential to restore lost functions or improve the quality of life for patients with severe neurological impairments. The precision and immediacy of this interface set it apart from existing treatments, promising more personalized and effective interventions.

What evidence suggests that this brain-computer interface device is effective for severe neurological disorders?

Research has shown that the PMT/Blackrock Combination Device, used by participants in this trial, might enable individuals with severe brain disorders to control devices with their thoughts. This trial will specifically examine the electrocorticography (ECoG)-based brain-computer interface, which effectively records brain activity and potentially allows users to control devices with their minds. The NeuroPort Electrode, a component of this device, is recognized for its safety and stability over extended periods, making it a reliable choice for ongoing use. Early research suggests that this technology could aid in movement and speech by interpreting complex brain signals. The device is under study for its potential to significantly enhance communication and movement for those affected by these disorders. ^{1 2 4 6 7}

Who Is on the Research Team?

Karunesh Ganguly, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults over 21 with severe limitations in upper limb use due to conditions like stroke, ALS, MS, or spinal cord injury. They must have significant disability and be at least one year post-symptom onset for strokes or injuries. Participants need to live within two hours of UCSF and cannot be pregnant, have certain mental health issues, substance abuse history, major organ failure, prior brain surgery or seizures.

Inclusion Criteria

I need help with daily activities due to my disability.

I have limited use of my arms due to a neurological condition.

It has been over a year since my stroke or spinal cord injury.

Exclusion Criteria

I have a history of seizures.

Inability to comply with study follow-up visits

Has a CSF drainage system or an active CSF leak

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Assessment

Participants undergo training and assessment of their ability to control a complex robotic system using ECoG signals

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

What Are the Treatments Tested in This Trial?

Interventions

• PMT/Blackrock Combination Device

Trial Overview The trial is testing a device combining PMT/Blackrock technology that uses brain signals (ECoG) for controlling motor and speech devices in those severely affected by neurological disorders.

How Is the Trial Designed?

Group I: Electrocorticography-based brain computer interface Experimental Treatment 1 Intervention

PMT/Blackrock Combination Device is already approved in United States for the following indications:

Approved in United States as PMT/Blackrock Combination Device for:

• Severe neurological disorders requiring motor and speech control assistance

Who Is Running the Clinical Trial?

Karunesh Ganguly

Lead Sponsor

Trials

1

Recruited

3+

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Brain-Machine Interface (BMI) technology allows users to control devices like robotic arms and tablets using their brain activity, showing promise for helping individuals with motor disabilities.

Regular use of BMI can enhance brain plasticity, potentially leading to improved neurological recovery and functional reorganization of the sensorimotor nervous system in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Brain-Machine Interface and Neuro-Rehabilitation]. Ushiba, J.[2019]

Brain-machine interface (BMI) technology has advanced significantly over the past decade and is nearing clinical application to help restore neural functions in patients with severe neurological impairments.

In addition to its therapeutic potential, BMI serves as a valuable tool for studying brain signal processing and understanding neural dysfunction, which could lead to new treatments for various neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Brain-machine interface (BMI) - application to neurological disorders]. Yoshimine, T., Yanagisawa, T., Hirata, M.[2019]

A first-generation, totally implantable neural interface was successfully used in 5 patients with Parkinson's disease, allowing for both continuous therapeutic stimulation and recording of brain activity over a 1-year period without serious complications.

The device demonstrated the feasibility of acquiring chronic multisite brain signals, which can enhance our understanding of neural networks and potentially improve future neurostimulation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic multisite brain recordings from a totally implantable bidirectional neural interface: experience in 5 patients with Parkinson's disease. Swann, NC., de Hemptinne, C., Miocinovic, S., et al.[2019]

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 'neurocommunicator' brain-machine interface developed for patients with severe motor deficits can accurately identify messages from EEG data with over 95% accuracy, allowing for communication at a rate of about 32 bits per minute.

The system combines a portable EEG recorder, a high-speed decoding algorithm, and a hierarchical message generation system, but further technical improvements are needed for effective use in home settings for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of a cognitive BMI "neurocommunicator" as a communication aid of patients with severe motor deficits]. Hasegawa, RP.[2019]

Invasive brain-machine interfaces (BMIs) have made significant advancements over the past two decades, particularly in their ability to record high-resolution neural signals, which is crucial for restoring motor functions in paralyzed individuals.

The transition of BMI technology from successful animal research to clinical trials shows promise in helping people regain lost motor abilities, highlighting both the potential benefits and the challenges that lie ahead in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Invasive Brain Machine Interface System. Jin, Y., Chen, J., Zhang, S., et al.[2020]

Brain-computer interfaces (BCIs) have the potential to significantly improve the quality of life for individuals with neurological conditions by enabling communication and interaction with their environment.

The paper discusses the principles and challenges of implementing BCIs in neurorehabilitation, highlighting the need for effective clinical translation to ensure these technologies can be successfully integrated into patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interfaces in Neurorecovery and Neurorehabilitation. Young, MJ., Lin, DJ., Hochberg, LR.[2023]

The Brain Machine Interface (BMI) system, specifically the ECoG-BMI, aims to improve the quality of life for paralyzed patients by interpreting brain activity and controlling devices accordingly.

The developed device features a high-density electrode array for effective ECoG signal recording, a compact circuit board for signal processing, and a wireless power supply, demonstrating a significant advancement in the integration and functionality of BMI technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an implantable wireless ECoG 128ch recording device for clinical brain machine interface. Matsushita, K., Hirata, M., Suzuki, T., et al.[2020]

The developed Brain-Computer Interface (BCI) system achieved an impressive average classification accuracy of 91.3% and an Information Transfer Rate (ITR) of 2.2 commands per minute, demonstrating its effectiveness in translating EEG signals into commands.

Using a simple classification technique (Nearest Neighbour Approach), the BCI system elicited strong P300 responses, showing that intuitive graphical user interfaces can lead to competitive performance compared to more complex systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of Graphical User Interface in the design of P300 based Brain-Computer Interface systems. Ratcliffe, L., Puthusserypady, S.[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]

Invasive Brain-Machine Interface (BMI) technology has shown promise in allowing individuals with severe movement and communication disorders to directly control assistive devices, as demonstrated in recent pilot clinical studies.

These studies have sparked interest among healthcare providers and patients, highlighting the potential of BMI technology to improve the quality of life for people with disabilities, while also addressing the challenges and future directions for its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical neuroprosthetics from a clinical perspective. Tsu, AP., Burish, MJ., GodLove, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11419230/

Quantifying physical degradation alongside recording and ... Quantifying physical degradation alongside recording and stimulation performance of 980 intracortical microelectrodes chronically implanted in three humans for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03698149

NCT03698149 | ECoG BMI for Motor and Speech Control ECoG is a type of electrophysiological monitoring that uses electrodes placed directly on the exposed surface of the brain to record electrical activity. With ...

3. blackrockneurotech.com blackrockneurotech.com/products/neuroport-electrode/

NeuroPort Electrode 96 The NeuroPort Electrode is designed to be safe, versatile in its utility and stable in its effectiveness for extended periods of time.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03567213

Investigation on the Cortical Communication (CortiCom ... Through this study, investigators will assess the performance of speech- and motor-mediated control using chronic, high-channel count ECoG grid neural implants ...

5. thejns.org thejns.org/focus/view/journals/neurosurg-focus/27/1/article-pE9.xml

Human neocortical electrical activity recorded on ... The goal of this study was to determine whether a nonpenetrating, high-density microwire array could provide sufficient information to serve as the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11494178/

A click-based electrocorticographic brain-computer interface ... We sought to test the performance and long-term stability of click decoding using a chronically implanted high density electrocorticographic (ECoG) BCI.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2941644/

Human neocortical electrical activity recorded on ... The goal of this study was to determine whether a nonpenetrating, high-density microwire array could provide sufficient information to serve as the interface ...