BrainGate2 System for Speech Impairment

(BG-Speech-02 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sergey Stavisky, 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?

The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

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 data supports the effectiveness of the BrainGate2 System for Speech Impairment treatment?

Research shows that the BrainGate Neural Interface System can help people with severe communication disorders, like those with locked-in syndrome, to communicate using a computer interface. Studies have demonstrated that individuals can achieve accurate and fast typing using this system, which suggests it could be effective for speech impairment as well. ^{1 2 3 4 5}

What makes the BrainGate2 System treatment unique for speech impairment?

The BrainGate2 System is unique because it uses an intracortical brain-computer interface (BCI) to enable neural point-and-click communication, allowing individuals with speech impairments to control a computer cursor and type using their brain signals. This approach is different from other treatments as it directly translates brain activity into communication, bypassing the need for muscle movement. ^{2 3 6 7 8}

Research Team

Sergey Stavisky, Ph.D.

Principal Investigator

University of California, Davis

Eligibility Criteria

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.

I am between 18 and 80 years old.

Trial Timeline

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

Treatment Details

Interventions

• BrainGate Neural Interface System (Neural Interface)

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.

Participant Groups

Group I: BrainGate Neural Interface System Experimental Treatment 1 Intervention

Placement of the BrainGate2 sensor(s) into the speech-related cortex

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+

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

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

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

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

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

Neural Point-and-Click Communication by a Person With Incomplete Locked-In Syndrome. [2019]

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

The Potential for a Speech Brain-Computer Interface Using Chronic Electrocorticography. [2023]

4. 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]

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

Brain-Computer Interfaces for Augmentative and Alternative Communication: A Tutorial. [2020]

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

A click-based electrocorticographic brain-computer interface enables long-term high-performance switch-scan spelling. [2023]

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

The portable P300 dialing system based on tablet and Emotiv Epoc headset. [2020]

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

An offline auditory P300 brain-computer interface using principal and independent component analysis techniques for functional electrical stimulation application. [2020]