BrainGate2 System for Speech Impairment

(BG-Speech-02 Trial)

Recruiting at 1 trial location

Overseen By Sergey Stavisky, 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

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have lost the ability to speak fluently due to conditions such as spinal cord injury or ALS (a nervous system disease). The study tests a device called the BrainGate Neural Interface System, which enables users to communicate through a computer by attempting to speak. Suitable candidates for this study include those with speech impairments from specific conditions who can travel to the study site within three hours. Participants should not have serious visual impairments or be on long-term steroid or immunosuppressive therapies. As an unphased trial, this research offers participants the chance to contribute to groundbreaking advancements that could transform communication methods for those with speech impairments.

Will I have to stop taking my current medications?

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

What prior data suggests that the BrainGate Neural Interface System is safe for speech impairment?

Previous studies have shown that the BrainGate Neural Interface System has a low rate of serious side effects, meaning few severe negative effects have been reported. One study, which included 12,203 days of participant experience, showed positive safety results, suggesting that users generally tolerate the system well. The BrainGate system helps people communicate using their thoughts when they cannot speak easily. Research so far indicates that the system is safe for use in humans. ^{1 2 3 4}

Why are researchers excited about this trial?

The BrainGate Neural Interface System is unique because it directly targets the speech-related cortex in the brain with a neural interface. Unlike traditional speech therapy or assistive devices that rely on external aids, this system involves the placement of sensors that can potentially translate brain signals into speech. Researchers are excited about this treatment because it offers a novel way to restore communication for individuals who have lost the ability to speak, such as those with severe paralysis or neurological conditions. By focusing on the brain's natural speech pathways, the BrainGate system aims to provide a more intuitive and immediate form of communication compared to existing options.

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

Research has shown that the BrainGate Neural Interface System, which participants in this trial will receive, can assist people with severe communication problems, such as those with locked-in syndrome, in communicating. The system operates by placing small sensors in the brain areas that control speech. These sensors detect brain signals when a person attempts to speak and convert them into computer commands. This can aid individuals who have lost the ability to speak clearly due to conditions like ALS or a stroke. Although researchers continue to study the system, it has shown promise in helping people express their thoughts through communication. ^{1 2 4 5 6}

Who Is on the Research Team?

Sergey Stavisky, Ph.D.

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for people with severe paralysis (tetraplegia) due to conditions like spinal cord injury or ALS, who live close to the study site and have stable health. They should be between 18-80 years old, at least a year post-injury, and able to communicate in some way.

Inclusion Criteria

I have paralysis affecting all four limbs.

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

I have a diagnosed condition affecting my nerves or muscles, such as ALS or muscular dystrophy.

Exclusion Criteria

Doctors believe you will live for more than 6 months.

It's been over a year since my injury, and my recovery has been stable for the last 3 months.

Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Evaluation

Placement of the BrainGate2 sensor(s) into the speech-related cortex and initial evaluation of the implant

1 year

Long-term Follow-up

Participants are monitored for safety and effectiveness of the implant, including speech output accuracy

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. It's a device that could help people with speech impairments caused by paralysis communicate through a computer by attempting to speak.

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

A chronically implanted ECoG brain-computer interface (BCI) allowed a participant with ALS to achieve a median spelling rate of 10.2 characters per minute using a click-decoding method, demonstrating effective communication capabilities.

The click decoder maintained robust performance over 90 days without retraining, even after being trained on a small dataset of less than 44 minutes, indicating its long-term stability and potential for practical use in communication for individuals with movement and speech impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A click-based electrocorticographic brain-computer interface enables long-term high-performance switch-scan spelling. Crone, N., Candrea, D., Shah, S., et al.[2023]

A P300 brain-computer interface (BCI) allows individuals with severe disabilities to communicate and control devices by detecting specific brain responses to stimuli, as recorded by EEG.

Auditory BCIs are particularly advantageous because they enable users to maintain visual focus on their tasks, making them more practical for real-world applications compared to visual stimulus BCIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An offline auditory P300 brain-computer interface using principal and independent component analysis techniques for functional electrical stimulation application. Bentley, AS., Andrew, CM., John, LR.[2020]

The study demonstrated that a mobile brain-computer interface (BCI) using a 14-channel Emotiv EPOC headset can effectively translate brain signals into control signals, achieving an average classification accuracy of 88.75% in a lab setting and 73.75% in a real-world metro environment.

The BCI system showed promising information transfer rates of 7.17 bits/min in the lab and 5.05 bits/min in the metro, indicating its potential to improve communication for patients with motor diseases like ALS and multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The portable P300 dialing system based on tablet and Emotiv Epoc headset. Tong Jijun, ., Zhang Peng, ., Xiao Ran, ., et al.[2020]

Brain-computer interfaces (BCIs) for speech have the potential to restore communication for patients with severe communication disorders, utilizing neural signals to enable real-time speech generation.

Recent advancements in neural decoding techniques, particularly using electrocorticography (ECoG), show promise for accurately interpreting speech-related neural activity, although significant challenges remain for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential for a Speech Brain-Computer Interface Using Chronic Electrocorticography. Rabbani, Q., Milsap, G., Crone, NE.[2023]

The study successfully demonstrated that an individual with incomplete locked-in syndrome could communicate using a brain-computer interface, achieving typing rates of over 10 correct characters per minute.

The novel BrainGate Radial Keyboard significantly improved typing accuracy and speed compared to a standard QWERTY keyboard, enabling effective communication through text-to-speech and internet chat applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Point-and-Click Communication by a Person With Incomplete Locked-In Syndrome. Bacher, D., Jarosiewicz, B., Masse, NY., et al.[2019]

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]

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]

Brain-computer interfaces (BCIs) are emerging as valuable tools for enhancing communication in individuals who cannot use traditional augmentative and alternative communication (AAC) devices, providing a new access method rather than a replacement for existing AAC strategies.

Speech-language pathologists (SLPs) should leverage their existing AAC knowledge to integrate BCIs into clinical practice, while also pursuing further training to keep up with the fast-paced developments in BCI technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interfaces for Augmentative and Alternative Communication: A Tutorial. Brumberg, JS., Pitt, KM., Mantie-Kozlowski, A., et al.[2020]

Citations

1. 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 ...

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/

BrainGate - Turning Thought Into Action BrainGate is developing and testing practical, groundbreaking medical devices to restore communication, mobility and independence to people affected by ...

4. 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 ...

5. withpower.com withpower.com/trial/phase-muscular-dystrophies-9-2024-ec154

BrainGate2 System for Speech Impairment Research shows that the BrainGate Neural Interface System can help people with severe communication disorders, like those with locked-in syndrome, to ...

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

Interim Safety Feasibility Study of the BrainGate Neural ... In Neurology, they report favorable safety data from 12,203 participant-days of experience. ... interfaces toward helping people with severe ...