BrainGate Neural Interface for Tetraplegia

(BG-Tablet-01 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Leigh R Hochberg, MD, 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, Immunosuppressants

Disqualifiers: Visual impairment, Serious disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people 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 it excludes those on chronic steroids or immunosuppressive therapy. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the BrainGate Neural Interface System treatment for tetraplegia?

Research shows that the BrainGate Neural Interface System allows people with tetraplegia to control a tablet computer using their brain signals, demonstrating its potential to help paralyzed individuals interact with technology and improve their daily lives. ^{1 2 3 4 5}

Is the BrainGate Neural Interface 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. While the study focuses on people with paralysis, it offers valuable insights into the safety of chronically implanted microelectrode arrays in humans. ^{2 3 6 7 8}

How is the BrainGate Neural Interface System treatment different from other treatments for tetraplegia?

The BrainGate Neural Interface System is unique because it uses a small, implanted device in the brain to directly translate neural activity into control signals for assistive technologies, allowing people with tetraplegia to control devices like computers and tablets with their thoughts. This approach differs from other treatments as it provides a direct brain-computer interface, enabling more natural and precise control over technology without relying on muscle movement. ^{1 4 5 6 7}

Research Team

Leigh R Hochberg, MD, Ph.D.

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals with severe paralysis due to conditions like brainstem stroke, ALS (Lou Gehrig's Disease), or spinal cord injuries leading to quadriplegia. Participants should be unable to move or speak but remain alert. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Prior enrollment in BrainGate2 clinical trial (NCT00912041)

Must live within a three-hour drive of the Study site

I have paralysis in all four limbs.

Exclusion Criteria

Other serious disease or disorder that could seriously affect ability to participate in the study

Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses

I am not on long-term steroids or drugs that weaken my immune system.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Testing

Participants undergo implantation of the BrainGate Neural Interface System and initial testing of the device

4-6 weeks

Long-term Evaluation

Participants are monitored for safety and effectiveness of the BrainGate Neural Interface System over a one-year period

1 year

Follow-up

Participants are monitored for safety and effectiveness after the main evaluation period

4 weeks

Treatment Details

Interventions

• BrainGate Neural Interface System (Brain-Computer Interface)

Trial Overview The BrainGate2 Neural Interface System is being tested. It's a cutting-edge technology designed to interpret brain signals and enable people with paralysis to use communication apps on tablets using their thoughts.

Participant Groups

Group I: BrainGate Neural Interface System Experimental Treatment 1 Intervention

Device: BrainGate Neural Interface System

Who Is Running the Clinical Trial?

Leigh R. Hochberg, MD, PhD.

Lead Sponsor

Trials

4

Recruited

30+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Joshua M. Levy

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Medical Officer

MD, MPH, MS

Debara L. Tucci

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Executive Officer since 2019

MD, MS, MBA

Brown University

Collaborator

Trials

480

Recruited

724,000+

Mukesh Jain

Brown University

Chief Medical Officer since 2022

MD from Harvard Medical School

Christina H. Paxson

Brown University

Chief Executive Officer since 2012

PhD in Economics from Columbia University

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]

A 28-year-old man with tetraplegia successfully controlled a neuroprosthetic exoskeleton using brain signals for 24 months, achieving a success rate of 70.9% in laboratory settings and 64.0% at home, demonstrating the feasibility of this semi-invasive technique.

The study utilized epidural electrocorticographic (ECoG) signals, which proved to be effective and reusable for up to 7 weeks without recalibration, indicating a promising method for long-term brain-machine interface applications in mobility restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Benabid, AL., Costecalde, T., Eliseyev, A., et al.[2020]

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]

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]

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

An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. [2020]

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

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

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

The science of neural interface systems. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. 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]

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]