BrainGate Neural Interface for Tetraplegia
(BG-Tablet-01 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byLeigh 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?
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.23678
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.14567
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.
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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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: BrainGate Neural Interface SystemExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Masssachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Leigh R. Hochberg, MD, PhD.Lead Sponsor
Stanford UniversityCollaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
Brown UniversityCollaborator
References
Cortical control of a tablet computer by people with paralysis. [2023]General-purpose computers have become ubiquitous and important for everyday life, but they are difficult for people with paralysis to use. Specialized software and personalized input devices can improve access, but often provide only limited functionality. In this study, three research participants with tetraplegia who had multielectrode arrays implanted in motor cortex as part of the BrainGate2 clinical trial used an intracortical brain-computer interface (iBCI) to control an unmodified commercial tablet computer. Neural activity was decoded in real time as a point-and-click wireless Bluetooth mouse, allowing participants to use common and recreational applications (web browsing, email, chatting, playing music on a piano application, sending text messages, etc.). Two of the participants also used the iBCI to "chat" with each other in real time. This study demonstrates, for the first time, high-performance iBCI control of an unmodified, commercially available, general-purpose mobile computing device by people with tetraplegia.
An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. [2020]Approximately 20% of traumatic cervical spinal cord injuries result in tetraplegia. Neuroprosthetics are being developed to manage this condition and thus improve the lives of patients. We aimed to test the feasibility of a semi-invasive technique that uses brain signals to drive an exoskeleton.
An implantable wireless neural interface for recording cortical circuit dynamics in moving primates. [2021]Neural interface technology suitable for clinical translation has the potential to significantly impact the lives of amputees, spinal cord injury victims and those living with severe neuromotor disease. Such systems must be chronically safe, durable and effective.
The science of neural interface systems. [2021]The ultimate goal of neural interface research is to create links between the nervous system and the outside world either by stimulating or by recording from neural tissue to treat or assist people with sensory, motor, or other disabilities of neural function. Although electrical stimulation systems have already reached widespread clinical application, neural interfaces that record neural signals to decipher movement intentions are only now beginning to develop into clinically viable systems to help paralyzed people. We begin by reviewing state-of-the-art research and early-stage clinical recording systems and focus on systems that record single-unit action potentials. We then address the potential for neural interface research to enhance basic scientific understanding of brain function by offering unique insights in neural coding and representation, plasticity, brain-behavior relations, and the neurobiology of disease. Finally, we discuss technical and scientific challenges faced by these systems before they are widely adopted by severely motor-disabled patients.
Walking naturally after spinal cord injury using a brain-spine interface. [2023]A spinal cord injury interrupts the communication between the brain and the region of the spinal cord that produces walking, leading to paralysis1,2. Here, we restored this communication with a digital bridge between the brain and spinal cord that enabled an individual with chronic tetraplegia to stand and walk naturally in community settings. This brain-spine interface (BSI) consists of fully implanted recording and stimulation systems that establish a direct link between cortical signals3 and the analogue modulation of epidural electrical stimulation targeting the spinal cord regions involved in the production of walking4-6. A highly reliable BSI is calibrated within a few minutes. This reliability has remained stable over one year, including during independent use at home. The participant reports that the BSI enables natural control over the movements of his legs to stand, walk, climb stairs and even traverse complex terrains. Moreover, neurorehabilitation supported by the BSI improved neurological recovery. The participant regained the ability to walk with crutches overground even when the BSI was switched off. This digital bridge establishes a framework to restore natural control of movement after paralysis.
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.
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.
Brainport: an alternative input to the brain. [2022]Brain Computer Interface (BCI) technology is one of the most rapidly developing areas of modern science; it has created numerous significant crossroads between Neuroscience and Computer Science. The goal of BCI technology is to provide a direct link between the human brain and a computerized environment. The objective of recent BCI approaches and applications have been designed to provide the information flow from the brain to the computerized periphery. The opposite or alternative direction of the flow of information (computer to brain interface, or CBI) remains almost undeveloped. The BrainPort is a CBI that offers a complementary technology designed to support a direct link from a computerized environment to the human brain - and to do so non-invasively. Currently, BrainPort research is pursuing two primary goals. One is the delivery of missing sensory information critical for normal human behavior through an additional artificial sensory channel around the damaged or malfunctioning natural sensory system. The other is to decrease the risk of sensory overload in human-machine interactions by providing a parallel and supplemental channel for information flow to the brain. In contrast, conventional CBI strategies (e.g., Virtual Reality), are usually designed to provide additional or substitution information through pre-existing sensory channels, and unintentionally aggravate the brain overload problem.