BrainGate Neural Interface for Tetraplegia

(BG-Tablet-01 Trial)

Overseen By Leigh R Hochberg, MD, Ph.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 aims to assist individuals unable to move or speak due to conditions such as brainstem stroke or advanced ALS. Researchers seek to enhance a brain-computer interface that enables individuals with paralysis to use communication apps on tablets. The study tests a device called the BrainGate Neural Interface System. Individuals with paralysis from conditions like spinal cord injury, brainstem stroke, or ALS, who reside within a three-hour drive of the study site, may be suitable candidates. As an unphased trial, participants can contribute to groundbreaking research that may improve communication for those with severe 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 prior data suggests that the BrainGate Neural Interface System is safe for use in people with paralysis?

Research has shown that the BrainGate Neural Interface System is likely safe for humans. Studies found that this system, implanted through surgery, rarely causes serious side effects.

Previous studies gathered early safety information about this system. The results suggested that most patients handle the device well. However, while the overall safety outlook is positive, individual experiences can differ. Always consult a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BrainGate Neural Interface System is unique because it directly taps into the brain's signals to help individuals with tetraplegia regain control over devices. Unlike traditional treatments that might involve physical therapy or assistive technologies like voice-controlled devices, BrainGate uses a neural interface to convert brain activity into commands for external devices. This groundbreaking technology has the potential to offer more intuitive and direct control, which could significantly improve the quality of life for those with severe paralysis. Researchers are excited because this system could pave the way for unprecedented autonomy and communication capabilities for individuals living with tetraplegia.

What evidence suggests that the BrainGate Neural Interface System is effective for communication in people with paralysis?

Research has shown that the BrainGate Neural Interface System, which participants in this trial will receive, can help people with tetraplegia (paralysis of all four limbs) control a tablet using their brain signals. Early findings suggest that this system can assist individuals who cannot move or speak, due to conditions like ALS or strokes, in communicating again. The technology reads brain signals related to movement, allowing users to interact with devices naturally. Previous studies have extensively used the system and demonstrated its safety. Although this new approach is still under study, early results are promising for those seeking to regain communication abilities. ^{1 4 6 7 8}

Who Is on the Research Team?

Leigh R Hochberg, MD, Ph.D.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BrainGate Neural Interface System

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.

How Is the Trial Designed?

Group I: BrainGate Neural Interface System Experimental Treatment 1 Intervention

Device: BrainGate Neural Interface System

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+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. 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.

2. 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 ...

3. 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 ...

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-wounds-and-injuries-7-2024-2be46

BrainGate Neural Interface for Tetraplegia Research shows that the BrainGate Neural Interface System allows people with tetraplegia to control a tablet computer using their brain signals, demonstrating ...

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. studypages.com studypages.com/s/braingate2-feasibility-study-of-an-intracortical-neural-interface-system-for-persons-with-tetraplegia-378088/

BrainGate2: Feasibility Study of an Intracortical Neural ... The purpose of the pilot clinical study of the BrainGate2 Neural Interface System is to obtain preliminary device safety information and to demonstrate the ...