BrainGate2 System for Quadriplegia (BG-Speech-01 Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByJaimie Henderson, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Leigh R. Hochberg, MD, PhD.
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
Is the BrainGate2 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. Although the study focuses on people with paralysis, it offers valuable insights into the safety of chronically implanted microelectrode arrays in humans.
134611How is the BrainGate2 treatment unique for quadriplegia?
The BrainGate2 treatment is unique because it uses a brain-computer interface (BCI) that directly connects with the nervous system to read motor intentions from the brain, allowing people with quadriplegia to control devices like tablets and prosthetics with their thoughts. This approach is different from traditional treatments as it provides a direct neural link to restore function and independence.
238910What data supports the effectiveness of the BrainGate2 treatment for quadriplegia?
Research shows that the BrainGate2 system allows people with paralysis to control devices like tablets and computers using their brain signals, demonstrating its potential to improve daily life activities. Additionally, similar brain-computer interfaces have been used to restore hand function and enable walking in individuals with spinal cord injuries, indicating the effectiveness of such systems in restoring movement and control.
5781012Will 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 study team.
Eligibility Criteria
This trial is for adults aged 18-80 with tetraplegia due to conditions like ALS, spinal cord injury, or stroke. They must be unable to speak clearly or at all but have one reliable way to communicate. Participants should live within a three-hour drive of the study site and are expected to survive more than six months.Inclusion Criteria
I have ALS and cannot speak or have severe speech difficulties that have worsened recently.
I have been diagnosed with ALS by a neurology specialist.
Exclusion Criteria
I have paralysis that affects all four of my limbs.
I am between 18 and 80 years old.
Participant Groups
The BrainGate2 Neural Interface System is being tested for its safety and ability to let people with severe paralysis control a computer cursor and other devices using their thoughts alone.
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:
Stanford University School of MedicineStanford, CA
Massachusetts General HospitalBoston, MA
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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
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.
Brain-computer interface technology as a tool to augment plasticity and outcomes for neurological rehabilitation. [2018]Brain-computer interfaces (BCIs) are a rehabilitation tool for tetraplegic patients that aim to improve quality of life by augmenting communication, control of the environment, and self-care. The neurobiology of both rehabilitation and BCI control depends upon learning to modify the efficacy of spared neural ensembles that represent movement, sensation and cognition through progressive practice with feedback and reward. To serve patients, BCI systems must become safe, reliable, cosmetically acceptable, quickly mastered with minimal ongoing technical support, and highly accurate even in the face of mental distractions and the uncontrolled environment beyond a laboratory. BCI technologies may raise ethical concerns if their availability affects the decisions of patients who become locked-in with brain stem stroke or amyotrophic lateral sclerosis to be sustained with ventilator support. If BCI technology becomes flexible and affordable, volitional control of cortical signals could be employed for the rehabilitation of motor and cognitive impairments in hemiplegic or paraplegic patients by offering on-line feedback about cortical activity associated with mental practice, motor intention, and other neural recruitment strategies during progressive task-oriented practice. Clinical trials with measures of quality of life will be necessary to demonstrate the value of near-term and future BCI applications.
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.
Brain-computer interface controlled gaming: evaluation of usability by severely motor restricted end-users. [2013]Connect-Four, a new sensorimotor rhythm (SMR) based brain-computer interface (BCI) gaming application, was evaluated by four severely motor restricted end-users; two were in the locked-in state and had unreliable eye-movement.
Restoring sensorimotor function through intracortical interfaces: progress and looming challenges. [2022]The loss of a limb or paralysis resulting from spinal cord injury has devastating consequences on quality of life. One approach to restoring lost sensory and motor abilities in amputees and patients with tetraplegia is to supply them with implants that provide a direct interface with the CNS. Such brain-machine interfaces might enable a patient to exert voluntary control over a prosthetic or robotic limb or over the electrically induced contractions of paralysed muscles. A parallel interface could convey sensory information about the consequences of these movements back to the patient. Recent developments in the algorithms that decode motor intention from neuronal activity and in approaches to convey sensory feedback by electrically stimulating neurons, using biomimetic and adaptation-based approaches, have shown the promise of invasive interfaces with sensorimotor cortices, although substantial challenges remain.
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.
Brain-Computer Interfaces in Quadriplegic Patients. [2019]Brain-computer interfaces (BCI) are implantable devices that interface directly with the nervous system. BCI for quadriplegic patients restore function by reading motor intent from the brain and use the signal to control physical, virtual, and native prosthetic effectors. Future closed-loop motor BCI will incorporate sensory feedback to provide patients with an effective and intuitive experience. Development of widely available BCI for patients with neurologic injury will depend on the successes of today's clinical BCI. BCI are an exciting next step in the frontier of neuromodulation.
Implantable brain-computer interface for neuroprosthetic-enabled volitional hand grasp restoration in spinal cord injury. [2023]Loss of hand function after cervical spinal cord injury severely impairs functional independence. We describe a method for restoring volitional control of hand grasp in one 21-year-old male subject with complete cervical quadriplegia (C5 American Spinal Injury Association Impairment Scale A) using a portable fully implanted brain-computer interface within the home environment. The brain-computer interface consists of subdural surface electrodes placed over the dominant-hand motor cortex and connects to a transmitter implanted subcutaneously below the clavicle, which allows continuous reading of the electrocorticographic activity. Movement-intent was used to trigger functional electrical stimulation of the dominant hand during an initial 29-weeks laboratory study and subsequently via a mechanical hand orthosis during in-home use. Movement-intent information could be decoded consistently throughout the 29-weeks in-laboratory study with a mean accuracy of 89.0% (range 78-93.3%). Improvements were observed in both the speed and accuracy of various upper extremity tasks, including lifting small objects and transferring objects to specific targets. At-home decoding accuracy during open-loop trials reached an accuracy of 91.3% (range 80-98.95%) and an accuracy of 88.3% (range 77.6-95.5%) during closed-loop trials. Importantly, the temporal stability of both the functional outcomes and decoder metrics were not explored in this study. A fully implanted brain-computer interface can be safely used to reliably decode movement-intent from motor cortex, allowing for accurate volitional control of hand grasp.
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.