BrainGate2 Neural Interface for Quadriplegia

(BrainGate2 Trial)

Recruiting at 4 trial locations

Overseen By Leigh R Hochberg, M.D., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Leigh R. Hochberg, MD, PhD.

Must not be taking: Steroids, Immunosuppressives

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

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals with tetraplegia (paralysis in all four limbs) can control a computer cursor and other assistive devices using their thoughts. The focus is on testing the safety and feasibility of the BrainGate2 system, a neural interface designed to help individuals regain some degree of independence. People with conditions like spinal cord injury or ALS, who have complete or partial paralysis, might be suitable candidates if they live within a three-hour drive of the study site. Participants should not have significant vision problems or be on certain medications that could affect participation. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance independence for individuals with paralysis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on chronic steroids or immunosuppressive therapy.

What prior data suggests that the BrainGate2 Neural Interface System is safe for people with tetraplegia?

Research has shown that the BrainGate2 Neural Interface system is generally safe for people. Studies have found that this device, surgically placed in the brain, rarely causes major problems. These studies primarily aim to ensure the system's safety. So far, results are encouraging, indicating that most people tolerate the device well. Prospective trial participants may find these findings reassuring regarding its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BrainGate2 Neural Interface System because it offers a revolutionary approach for individuals with quadriplegia. Unlike traditional treatments that rely on physical rehabilitation or assistive devices, BrainGate2 directly interfaces with the brain's neural signals to control external devices. This system uses an implant that detects brain activity, allowing users to control computers or prosthetic limbs with their thoughts. This innovative method could greatly enhance independence and quality of life for people with severe motor impairments.

What evidence suggests that the BrainGate2 Neural Interface System is effective for controlling assistive devices with thoughts?

Research shows that the BrainGate2 system, used by participants in this trial, enables people with paralysis to control devices like computers and tablets using brain signals. This means that even without physical movement, individuals might still use technology through thought alone. Studies have demonstrated that BrainGate2 has been used safely over an extended period, with over 17,000 days of data from users. These findings suggest that BrainGate2 could be a promising tool for helping people with quadriplegia gain greater independence. ^{2 4 6 7 8}

Who Is on the Research Team?

Leigh R Hochberg, M.D., Ph.D.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for people with conditions like ALS, muscular dystrophy, or spinal cord injuries that have led to tetraplegia. Participants must live close to the study site and be able to use a computer screen even with vision correction. They can't join if they're on chronic steroids/immunosuppressants or have other serious diseases.

Inclusion Criteria

I have paralysis affecting all four limbs.

I am sorry, I cannot provide a summary of additional inclusion criteria without having knowledge of the specific criteria that are being referred to. Could you please provide more information?

I have a condition affecting my nerves or muscles, like ALS or muscular dystrophy.

Exclusion Criteria

You have poor eyesight and would have difficulty looking at a computer screen even with glasses or contact lenses.

(There are additional exclusion criteria)

You have a serious health condition that may interfere with your ability to take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Implementation

Participants receive the BrainGate Neural Interface System to assess feasibility and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after device implementation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BrainGate2

Trial Overview The BrainGate2 study tests whether individuals with tetraplegia can control a computer cursor and other devices using their thoughts after having a sensor placed in their brain's motor cortex.

How Is the Trial Designed?

Group I: BrainGate Experimental Treatment 1 Intervention

BrainGate Neural Interface System

BrainGate2 is already approved in United States for the following indications:

Approved in United States as BrainGate2 for:

• Investigational use for tetraplegia to control computer cursors and assistive devices

Who Is Running the Clinical Trial?

Leigh R. Hochberg, MD, PhD.

Lead Sponsor

Trials

4

Recruited

30+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

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 (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]

Brain-computer interfaces (BCIs) are being developed to help individuals with severe neuromuscular disorders, like ALS and spinal cord injuries, communicate and control devices, even if they are completely paralyzed.

Current BCIs can transfer information at rates of 10-25 bits per minute, which, while limited, can still provide essential communication capabilities for users, and future advancements will require interdisciplinary collaboration and improved signal processing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-computer interfaces for communication and control. Wolpaw, JR., Birbaumer, N., McFarland, DJ., 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]

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]

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 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]

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]

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 ... The investigational BrainGate Neural Interface system has an encouraging safety record, with more than 17,000 person-array implant-days of data. All 12 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06094205

Feasibility of the BrainGate2 Neural Interface System in ... The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer ...

4. 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.

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.

8. advances.massgeneral.org advances.massgeneral.org/neuro/journal.aspx?id=2457

Interim Safety Feasibility Study of the BrainGate Neural ... Key findings. The neurosurgically placed BrainGate Neural Interface System is designed to transmit information directly from the cerebral cortex ...