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?

This trial tests a system that enables individuals with tetraplegia (paralysis of all four limbs) to control computers and assistive devices using their thoughts. The researchers aim to determine if the BrainGate Neural Interface System, a brain-computer interface, is safe and can assist people with ALS (a disease affecting nerve cells in the brain and spinal cord) who have difficulty speaking. This trial may suit someone diagnosed with ALS who experiences severe speech issues and lives within a three-hour drive of the study site. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could significantly enhance communication for those with ALS.

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.

What prior data suggests that the BrainGate Neural Interface System is safe for people with tetraplegia?

Research has shown that the BrainGate Neural Interface System, which involves a small device placed in the brain, is generally safe. Previous studies found a low rate of serious side effects, indicating that most people handle the device well. These studies primarily aim to confirm the system's safety, and the results so far are promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BrainGate Neural Interface System because it offers a groundbreaking approach for individuals with quadriplegia. Unlike traditional treatments, which often focus on rehabilitation or assistive devices, BrainGate directly interfaces with the brain's speech-related cortex. This innovative method allows for the potential restoration of communication and movement control by translating neural signals into commands for external devices. By bypassing damaged neural pathways, BrainGate could significantly enhance independence and quality of life for those living with severe paralysis.

What evidence suggests that the BrainGate Neural Interface System is effective for tetraplegia?

Research has shown that the BrainGate Neural Interface System, studied in this trial, helps people with paralysis control devices using their brain signals. Users can move a computer cursor or operate assistive devices simply by thinking about it. Previous participants demonstrated the ability to interact with technology in ways previously impossible for them. The system uses the brain's natural signals to achieve this. While the main focus has been on safety, early results are promising for helping people with tetraplegia gain more independence. ^{2 4 5 6 7}

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

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 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]

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]

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]

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]

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 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]

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 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-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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00912041

BrainGate2: Feasibility Study of an Intracortical Neural ... The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. One year post-implant evaluation period. Secondary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10074470/

Interim Safety Profile From the Feasibility Study of the ... This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those ...

3. braingate.org braingate.org/clinical-trials/

Clinical Trials The purpose of the pilot clinical study of the BrainGate2 Neural Interface System is to obtain preliminary device safety information.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06094205

Feasibility of the BrainGate2 Neural Interface System in ... The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical ...

5. withpower.com withpower.com/trial/phase-locked-in-syndrome-4-2009-35bda

BrainGate2 Neural Interface for Quadriplegia Research shows that the BrainGate2 treatment allows people with paralysis to control devices like tablets and computers using their brain signals, which can ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36639237/

Interim Safety Profile From the Feasibility Study of ... - PubMed This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs.

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000201707

Interim Safety Profile From the Feasibility Study of ... This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs.