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.
What safety data exists for the BrainGate2 System for Speech Impairment?The provided research does not contain specific safety data for the BrainGate2 System for Speech Impairment or its related names (BrainGate Neural Interface System, BrainGate, BrainGate2 Neural Interface System). The studies focus on different hearing and cochlear implant systems, not the BrainGate systems.56101113
What data supports the idea that BrainGate2 System for Speech Impairment is an effective treatment?The available research shows that the BrainGate2 System can help people with severe communication disorders, like those with locked-in syndrome, to communicate more effectively. One study demonstrated that a participant using the BrainGate system was able to type over 10 correct characters per minute using a special keyboard, which improved their ability to communicate with others. Another study showed that even 1000 days after the system was implanted, a person with tetraplegia could accurately control a computer cursor, achieving a 91.3% success rate in selecting targets. These results suggest that the BrainGate2 System can provide reliable and effective communication assistance for individuals with speech impairments.23789
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic oral or intravenous steroids or immunosuppressive therapy, you cannot participate in the trial.
Is the BrainGate Neural Interface System a promising treatment for speech impairment?Yes, the BrainGate Neural Interface System is a promising treatment for speech impairment. It allows people with severe communication challenges to use their brain signals to control a computer for communication. This system has shown success in enabling individuals to type and communicate effectively, improving their ability to interact with others.134812
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.
I have a diagnosed condition affecting my nerves or muscles, such as ALS or muscular dystrophy.
Exclusion Criteria
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.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: BrainGate Neural Interface SystemExperimental Treatment1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California, DavisStanford, CA
University of California, DavisSacramento, CA
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Who is running the clinical trial?
Leigh R. Hochberg, MD, PhD.Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
References
An offline auditory P300 brain-computer interface using principal and independent component analysis techniques for functional electrical stimulation application. [2020]A brain-computer interface (BCI) provides technology that allows communication and control for people who are unable to interact with their environment. A P300 BCI exploits the fact that external or internal stimuli may provide a recognition response in the brain's electrical activity which may be recorded by an electroencephalogram (EEG) to act as a control signal. Additionally an auditory BCI does not require the user to avert their visual attention away from the task at hand and is thus more practical in a real environment than other visual stimulus BCIs.
Neural control of cursor trajectory and click by a human with tetraplegia 1000 days after implant of an intracortical microelectrode array. [2022]The ongoing pilot clinical trial of the BrainGate neural interface system aims in part to assess the feasibility of using neural activity obtained from a small-scale, chronically implanted, intracortical microelectrode array to provide control signals for a neural prosthesis system. Critical questions include how long implanted microelectrodes will record useful neural signals, how reliably those signals can be acquired and decoded, and how effectively they can be used to control various assistive technologies such as computers and robotic assistive devices, or to enable functional electrical stimulation of paralyzed muscles. Here we examined these questions by assessing neural cursor control and BrainGate system characteristics on five consecutive days 1000 days after implant of a 4 × 4 mm array of 100 microelectrodes in the motor cortex of a human with longstanding tetraplegia subsequent to a brainstem stroke. On each of five prospectively-selected days we performed time-amplitude sorting of neuronal spiking activity, trained a population-based Kalman velocity decoding filter combined with a linear discriminant click state classifier, and then assessed closed-loop point-and-click cursor control. The participant performed both an eight-target center-out task and a random target Fitts metric task which was adapted from a human-computer interaction ISO standard used to quantify performance of computer input devices. The neural interface system was further characterized by daily measurement of electrode impedances, unit waveforms and local field potentials. Across the five days, spiking signals were obtained from 41 of 96 electrodes and were successfully decoded to provide neural cursor point-and-click control with a mean task performance of 91.3% ± 0.1% (mean ± s.d.) correct target acquisition. Results across five consecutive days demonstrate that a neural interface system based on an intracortical microelectrode array can provide repeatable, accurate point-and-click control of a computer interface to an individual with tetraplegia 1000 days after implantation of this sensor.
Neural Point-and-Click Communication by a Person With Incomplete Locked-In Syndrome. [2019]A goal of brain-computer interface research is to develop fast and reliable means of communication for individuals with paralysis and anarthria. We evaluated the ability of an individual with incomplete locked-in syndrome enrolled in the BrainGate Neural Interface System pilot clinical trial to communicate using neural point-and-click control. A general-purpose interface was developed to provide control of a computer cursor in tandem with one of two on-screen virtual keyboards. The novel BrainGate Radial Keyboard was compared to a standard QWERTY keyboard in a balanced copy-spelling task. The Radial Keyboard yielded a significant improvement in typing accuracy and speed-enabling typing rates over 10 correct characters per minute. The participant used this interface to communicate face-to-face with research staff by using text-to-speech conversion, and remotely using an internet chat application. This study demonstrates the first use of an intracortical brain-computer interface for neural point-and-click communication by an individual with incomplete locked-in syndrome.
The portable P300 dialing system based on tablet and Emotiv Epoc headset. [2020]A Brain-computer interface (BCI) is a novel communication system that translates brain signals into a control signal. Now with the appearance of the commercial EEG headsets and mobile smart platforms (tablet, smartphone), it is possible to develop the mobile BCI system, which can greatly improve the life quality of patients suffering from motor disease, such as amyotrophic lateral scleroses (ALS), multiple sclerosis, cerebral palsy and head trauma. This study adopted a 14-channel Emotiv EPOC headset and Microsoft surface pro 3 to realize a dialing system, which was represented by 4×3 matrices of alphanumeric characters. The performance of the online portable dialing system based on P300 is satisfying. The average classification accuracy reaches 88.75±10.57% in lab and 73.75±16.94% in metro, while the information transfer rate (ITR) reaches 7.17±1.80 and 5.05±2.17 bits/min respectively. This means the commercial EEG headset and tablet has good prospect in developing real time BCI system in realistic environments.
Totally implantable hearing system: Five-year hearing results. [2018]1) To provide long-term hearing outcome measures of a totally implantable hearing system (implant) and compare to the baseline unaided (BLU) and baseline aided (BLA) conditions, and 2) discuss relevant safety measures.
Use of Research Interfaces for Psychophysical Studies With Cochlear-Implant Users. [2019]A growing number of laboratories are using research interfaces to conduct experiments with cochlear-implant (CI) users. Because these interfaces bypass a subject's clinical sound processor, several concerns exist regarding safety and stimulation levels. Here we suggest best-practice approaches for how to safely and ethically perform this type of research and highlight areas of limited knowledge where further research is needed to help clarify safety limits. The article is designed to provide an introductory level of technical detail about the devices and the effects of electrical stimulation on perception and neurophysiology. From this, we summarize what should be the best practices in the field, based on the literature and our experience. Findings from the review of the literature suggest that there are three main safety concerns: (a) to prevent biological or neural damage, (b) to avoid presentation of uncomfortably loud sounds, and (c) to ensure that subjects have control over stimulus presentation. Researchers must pay close attention to the software-hardware interface to ensure that the three main safety concerns are closely monitored. An important area for future research will be the determination of the amount of biological damage that can occur from electrical stimulation from a CI placed in the cochlea, not in direct contact with neural tissue. As technology used in research with CIs evolve, some of these approaches may change. However, the three main safety principles outlined here are not anticipated to undergo change with technological advances.
Brain-Computer Interfaces for Augmentative and Alternative Communication: A Tutorial. [2020]Brain-computer interfaces (BCIs) have the potential to improve communication for people who require but are unable to use traditional augmentative and alternative communication (AAC) devices. As BCIs move toward clinical practice, speech-language pathologists (SLPs) will need to consider their appropriateness for AAC intervention.
The Potential for a Speech Brain-Computer Interface Using Chronic Electrocorticography. [2023]A brain-computer interface (BCI) is a technology that uses neural features to restore or augment the capabilities of its user. A BCI for speech would enable communication in real time via neural correlates of attempted or imagined speech. Such a technology would potentially restore communication and improve quality of life for locked-in patients and other patients with severe communication disorders. There have been many recent developments in neural decoders, neural feature extraction, and brain recording modalities facilitating BCI for the control of prosthetics and in automatic speech recognition (ASR). Indeed, ASR and related fields have developed significantly over the past years, and many lend many insights into the requirements, goals, and strategies for speech BCI. Neural speech decoding is a comparatively new field but has shown much promise with recent studies demonstrating semantic, auditory, and articulatory decoding using electrocorticography (ECoG) and other neural recording modalities. Because the neural representations for speech and language are widely distributed over cortical regions spanning the frontal, parietal, and temporal lobes, the mesoscopic scale of population activity captured by ECoG surface electrode arrays may have distinct advantages for speech BCI, in contrast to the advantages of microelectrode arrays for upper-limb BCI. Nevertheless, there remain many challenges for the translation of speech BCIs to clinical populations. This review discusses and outlines the current state-of-the-art for speech BCI and explores what a speech BCI using chronic ECoG might entail.
Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. [2023]Brain-computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis. Though supported by decades of preclinical data, the safety of chronically implanted microelectrode array BCIs in humans is unknown. We report safety results from the prospective, open-label, nonrandomized BrainGate feasibility study (NCT00912041), the largest and longest-running clinical trial of an implanted BCI.
Comparison of Active Bone Conduction Hearing Implant Systems in Unilateral and Bilateral Conductive or Mixed Hearing Loss. [2023]To assess and compare binaural benefits and subjective satisfaction of active bone conduction implant (BCI) in patients with bilateral conductive or mixed hearing loss fitted with bilateral BCI and patients with monaural conductive hearing loss fitted with monaural BCI.
Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. [2023]To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single-sided deafness (SSD).
A click-based electrocorticographic brain-computer interface enables long-term high-performance switch-scan spelling. [2023]Brain-computer interfaces (BCIs) can restore communication in movement- and/or speech-impaired individuals by enabling neural control of computer typing applications. Single command "click" decoders provide a basic yet highly functional capability.
Comparison of Speech Recognition and Hearing Preservation Outcomes Between the Mid-Scala and Lateral Wall Electrode Arrays. [2023]To assess speech recognition and hearing preservation (HP) outcomes with the Advanced Bionics Mid-Scala and SlimJ electrodes.