BrainGate2 System for Quadriplegia

(BG-Speech-01 Trial)

Recruiting at 1 trial location

Overseen By Jaimie Henderson, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Leigh R. Hochberg, MD, PhD.

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Visual impairment, Serious disease, 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

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on chronic steroids or immunosuppressive therapy. It's best to discuss your specific medications with the study team.

Is the BrainGate2 System safe for humans?

The BrainGate feasibility study, which is the largest and longest-running clinical trial of an implanted brain-computer interface, provides safety data for the BrainGate Neural Interface System. Although the study focuses on people with paralysis, it offers valuable insights into the safety of chronically implanted microelectrode arrays in humans. ^{1 2 3 4 5}

How is the BrainGate2 treatment unique for quadriplegia?

The BrainGate2 treatment is unique because it uses a brain-computer interface (BCI) that directly connects with the nervous system to read motor intentions from the brain, allowing people with quadriplegia to control devices like tablets and prosthetics with their thoughts. This approach is different from traditional treatments as it provides a direct neural link to restore function and independence. ^{5 6 7 8 9}

What data supports the effectiveness of the BrainGate2 treatment for quadriplegia?

Research shows that the BrainGate2 system allows people with paralysis to control devices like tablets and computers using their brain signals, demonstrating its potential to improve daily life activities. Additionally, similar brain-computer interfaces have been used to restore hand function and enable walking in individuals with spinal cord injuries, indicating the effectiveness of such systems in restoring movement and control. ^{7 8 10 11 12}

Who Is on the Research Team?

Jaimie Henderson, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with tetraplegia due to conditions like ALS, spinal cord injury, or stroke. They must be unable to speak clearly or at all but have one reliable way to communicate. Participants should live within a three-hour drive of the study site and are expected to survive more than six months.

Inclusion Criteria

I have ALS and cannot speak or have severe speech difficulties that have worsened recently.

I have been diagnosed with ALS by a neurology specialist.

Exclusion Criteria

I can communicate clearly or have a reliable way to communicate.

Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

I have paralysis that affects all four of my limbs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Testing

Placement of the BrainGate2 sensor(s) into the speech-related cortex and initial testing of the system

1-2 weeks

Post-Implant Evaluation

Participants are monitored for device safety and feasibility of using the BrainGate system for communication

1 year

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness of the device

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• BrainGate Neural Interface System

Trial Overview The BrainGate2 Neural Interface System is being tested for its safety and ability to let people with severe paralysis control a computer cursor and other devices using their thoughts alone.

How Is the Trial Designed?

Group I: BrainGate Neural Interface System Experimental Treatment 1 Intervention

Placement of the BrainGate2 sensor(s) into the speech-related cortex

BrainGate Neural Interface System is already approved in United States for the following indications:

Approved in United States as BrainGate for:

• Tetraplegia
• Spinal cord injury
• Brainstem stroke
• ALS

Who Is Running the Clinical Trial?

Leigh R. Hochberg, MD, PhD.

Lead Sponsor

Trials

4

Recruited

30+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

A new wireless neural interface microsystem has been developed that is safe and effective for chronic use, showing electrical stability and the ability to capture neural data for over a year in animal models.

This device, which transmits data wirelessly and is designed for human clinical use, could significantly enhance neuroprosthetic technology and improve the diagnosis and treatment of neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An implantable wireless neural interface for recording cortical circuit dynamics in moving primates. Borton, DA., Yin, M., Aceros, J., et al.[2021]

A portable, fully implanted brain-computer interface successfully restored hand grasp control in a 21-year-old male with complete cervical quadriplegia, achieving a mean decoding accuracy of 89.0% during a 29-week laboratory study.

The system demonstrated high accuracy (91.3% in open-loop and 88.3% in closed-loop trials) for controlling hand movements at home, indicating its potential for practical use in improving functional independence for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable brain-computer interface for neuroprosthetic-enabled volitional hand grasp restoration in spinal cord injury. Cajigas, I., Davis, KC., Meschede-Krasa, B., et al.[2023]

A brain-spine interface (BSI) was successfully developed to restore communication between the brain and spinal cord, allowing an individual with chronic tetraplegia to stand and walk naturally in various settings.

The BSI demonstrated high reliability over a year of use, and it not only enabled movement but also contributed to neurological recovery, allowing the participant to walk with crutches even when the device was turned off.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking naturally after spinal cord injury using a brain-spine interface. Lorach, H., Galvez, A., Spagnolo, V., et al.[2023]

Brain-machine interfaces (BMIs) have the potential to restore motor and sensory functions in amputees and patients with spinal cord injuries by allowing voluntary control over prosthetic limbs or paralyzed muscles.

Recent advancements in decoding motor intentions from brain activity and providing sensory feedback through electrical stimulation show promise for these invasive interfaces, but significant challenges still need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring sensorimotor function through intracortical interfaces: progress and looming challenges. Bensmaia, SJ., Miller, LE.[2022]

This study successfully demonstrated that individuals with tetraplegia can use an intracortical brain-computer interface (iBCI) to control a standard tablet computer, allowing them to perform various tasks like web browsing and messaging.

The iBCI enabled real-time communication between participants, showcasing its potential for enhancing social interaction and independence for people with paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical control of a tablet computer by people with paralysis. Nuyujukian, P., Albites Sanabria, J., Saab, J., et al.[2023]

Brain-Computer Interface (BCI) technology aims to create a direct link between the human brain and computers, facilitating information flow from the brain to machines, while the BrainPort represents a novel approach to send information from computers to the brain non-invasively.

The BrainPort seeks to deliver essential sensory information to individuals with damaged sensory systems and reduce sensory overload during human-machine interactions, offering a complementary solution to traditional methods that may exacerbate cognitive load.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brainport: an alternative input to the brain. Danilov, Y., Tyler, M.[2022]

The BrainGate neural interface system successfully provided accurate point-and-click control of a computer interface for a participant with tetraplegia, achieving a mean task performance of 91.3% correct target acquisition 1000 days after implantation of a microelectrode array.

Neural signals were reliably recorded from 41 out of 96 electrodes over five consecutive days, demonstrating the long-term feasibility of using implanted microelectrodes to control assistive technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural control of cursor trajectory and click by a human with tetraplegia 1000 days after implant of an intracortical microelectrode array. Simeral, JD., Kim, SP., Black, MJ., et al.[2022]

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]

The Connect-Four brain-computer interface (BCI) application showed variable effectiveness among four severely motor-restricted users, with one user achieving high accuracy while others had low to medium effectiveness, indicating that performance can differ significantly based on individual capabilities.

Despite lower effectiveness and efficiency compared to other BCI applications, the majority of users accepted the Connect-Four application positively, with two users expressing interest in using it for daily activities, highlighting its potential for entertainment purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-computer interface controlled gaming: evaluation of usability by severely motor restricted end-users. Holz, EM., Höhne, J., Staiger-Sälzer, P., et al.[2013]

Neural interfaces that can record brain signals to interpret movement intentions are in early development but show promise for helping paralyzed individuals, complementing existing electrical stimulation systems that are already in clinical use.

These interfaces not only aim to assist with disabilities but also enhance our understanding of brain function, including neural coding and the neurobiology of diseases, although there are significant technical challenges to overcome before widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The science of neural interface systems. Hatsopoulos, NG., Donoghue, JP.[2021]

Brain-computer interfaces (BCI) are promising devices that can help quadriplegic patients regain control by interpreting brain signals to operate physical and virtual prosthetics.

The future of BCI technology aims to include sensory feedback, which will enhance the user experience and effectiveness for patients with neurological injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interfaces in Quadriplegic Patients. Lee, MB., Kramer, DR., Peng, T., et al.[2019]

Brain-computer interfaces (BCIs) can significantly enhance the quality of life for tetraplegic patients by improving communication and control over their environment, relying on the brain's ability to adapt through practice and feedback.

For BCIs to be effective, they must be safe, reliable, and easy to use, even in distracting environments, and future clinical trials will be essential to assess their impact on patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-computer interface technology as a tool to augment plasticity and outcomes for neurological rehabilitation. Dobkin, BH.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

An implantable wireless neural interface for recording cortical circuit dynamics in moving primates. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Implantable brain-computer interface for neuroprosthetic-enabled volitional hand grasp restoration in spinal cord injury. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Walking naturally after spinal cord injury using a brain-spine interface. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Restoring sensorimotor function through intracortical interfaces: progress and looming challenges. [2022]

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

Cortical control of a tablet computer by people with paralysis. [2023]

6. Singapore pubmed.ncbi.nlm.nih.gov

Brainport: an alternative input to the brain. [2022]

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

Neural control of cursor trajectory and click by a human with tetraplegia 1000 days after implant of an intracortical microelectrode array. [2022]

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

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

Brain-computer interface controlled gaming: evaluation of usability by severely motor restricted end-users. [2013]

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

The science of neural interface systems. [2021]

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

Brain-Computer Interfaces in Quadriplegic Patients. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Brain-computer interface technology as a tool to augment plasticity and outcomes for neurological rehabilitation. [2018]