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

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Leigh R. Hochberg, MD, PhD.

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: Visual impairment, Serious disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study is evaluating whether people with tetraplegia may be able 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 you cannot participate if you are on chronic steroids or immunosuppressive therapy.

What data supports the effectiveness of the BrainGate2 treatment 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 help them perform everyday tasks. Additionally, similar brain-computer interface systems have been used to restore hand function and enable walking in people with spinal cord injuries, suggesting potential benefits for improving movement and independence. ^{1 2 3 4 5}

Is the BrainGate2 Neural Interface System safe for humans?

The BrainGate feasibility study, the largest and longest-running clinical trial of an implanted brain-computer interface, provides safety data indicating that the BrainGate Neural Interface System has been evaluated for safety in humans. ^{2 3 6 7 8}

How is the BrainGate2 treatment different from other treatments for quadriplegia?

BrainGate2 is unique because it uses a brain-computer interface (BCI) to allow people with quadriplegia to control devices like tablets directly with their thoughts, providing a new level of independence and interaction with technology that other treatments do not offer. ^{1 2 3 5 9}

Research Team

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

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• BrainGate2 (Neural Interface System)

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.

Participant Groups

Group I: BrainGate Experimental Treatment 1 Intervention

BrainGate Neural Interface System

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+

Findings from Research

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]

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]

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]

References

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

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

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

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

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

The science of neural interface systems. [2021]

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

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

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

Brain-Computer Interfaces in Quadriplegic Patients. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Brain-computer interfaces for communication and control. [2022]

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

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

8. Singapore pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

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