BrainGate Neural Interface for Tetraplegia (BG-Tablet-01 Trial)
Palo Alto (17 mi)Overseen byLeigh R Hochberg, MD, Ph.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Leigh R. Hochberg, MD, PhD.
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.
Is the BrainGate Neural Interface System a promising treatment for people with tetraplegia?Yes, the BrainGate Neural Interface System is a promising treatment for people with tetraplegia. It allows individuals to control computers and other devices using their thoughts, helping them regain some independence and perform everyday tasks like browsing the internet, sending messages, and even walking with assistance.34689
What safety data exists for the BrainGate Neural Interface for Tetraplegia?The BrainGate feasibility study (NCT00912041) is the largest and longest-running clinical trial of an implanted brain-computer interface (BCI) and provides safety data for the BrainGate Neural Interface System. This study is prospective, open-label, and nonrandomized, focusing on the safety of chronically implanted microelectrode arrays in humans. Additionally, the ongoing pilot clinical trial of the BrainGate system assesses the feasibility and reliability of using neural signals from implanted microelectrodes for controlling assistive technologies, demonstrating successful neural cursor control 1000 days post-implantation.24578
What data supports the idea that BrainGate Neural Interface for Tetraplegia is an effective treatment?The available research shows that the BrainGate Neural Interface allows people with tetraplegia to control a tablet computer using their brain signals. In one study, participants with paralysis were able to use a tablet for activities like web browsing, emailing, and chatting, which demonstrates the system's effectiveness in helping them interact with technology. This suggests that BrainGate can significantly improve the ability of people with tetraplegia to perform everyday tasks, making it an effective treatment option.13567
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 may be excluded from participating.
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
I have paralysis in all four limbs.
I have a condition affecting my nerves or muscles, like ALS or muscular dystrophy.
Exclusion Criteria
I am not on long-term steroids or drugs that weaken my immune system.
Treatment Details
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.
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
An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. [2019]An advanced neuroprosthesis that provides control of grasp-release, forearm pronation, and elbow extension to persons with cervical level spinal cord injury is described. The neuroprosthesis includes implanted and external components. The implanted components are a 10-channel stimulator-telemeter, leads and electrodes, and a joint angle transducer; the external components are a control unit and transmitter-receiver coil. The system has completed preclinical testing and has been implanted fully in 3 persons and partially in 1 person, all with tetraplegia caused by spinal cord injury at C5 and C6. The minimum follow-up time for any system component is 16 months. All subjects had improvements in grasp strength, range of motion, and ability to grasp objects and increased independence in activities of daily living. Each subject became a regular user of the neuroprosthesis and is satisfied with it. The implanted components have not caused any medical complications. The operation of the electrodes and sensors has been stable. The data show that this advanced neuroprosthetic system is safe and can provide grasping and reaching ability to individuals with cervical level spinal cord injury.
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.
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.
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.
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.
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.
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.
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.