Brain-Computer Interface for Paralysis (PRIME Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Neuralink Corp
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
Is the treatment Precise Robotically Implanted Brain-Computer Interface a promising treatment for paralysis?Yes, the Precise Robotically Implanted Brain-Computer Interface is a promising treatment for paralysis. It allows people with severe motor disabilities to control robotic arms or other devices using their brain signals. This technology can help improve the quality of life for individuals with paralysis by enabling them to perform tasks they couldn't do before.12469
What safety data exists for the Brain-Computer Interface for Paralysis?The safety of chronically implanted microelectrode array BCIs in humans is still being evaluated. The BrainGate feasibility study, the largest and longest-running clinical trial of an implanted BCI, provides some safety data. Additionally, Neuralink's approach with its high-bandwidth brain-machine interface system is being explored, though long-term biocompatibility and distributed recordings remain challenges. Informed consent in BCI research highlights risks such as short and long-term safety, cognitive and communicative impairment, and privacy concerns. These studies and discussions indicate ongoing efforts to understand and address safety in BCI technology.157811
What data supports the idea that Brain-Computer Interface for Paralysis is an effective treatment?The available research shows that Brain-Computer Interfaces (BCIs) can help people with paralysis by allowing them to control devices using their brain signals. For example, individuals with tetraplegia have been able to type quickly on screens and control tablet apps using BCIs. This suggests that BCIs can restore some level of independence and communication for people who cannot move. Additionally, noninvasive BCIs have shown similar effectiveness to invasive ones, providing movement control without needing brain implants. This makes BCIs a promising option compared to other assistive technologies that may not work as well for people with severe paralysis.123410
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 have conditions like poorly controlled seizures, epilepsy, or diabetes, you may not be eligible to participate.
Eligibility Criteria
This trial is for individuals with severe paralysis, including those with spinal cord injuries or diseases like ALS. Participants should have tetraplegia, meaning paralysis of all four limbs. Specific eligibility will be determined by the study team.Inclusion Criteria
I have had severe paralysis in all four limbs for at least a year without getting better.
Exclusion Criteria
I have a history of diabetes that is hard to control.
I have a history of seizures or epilepsy that is hard to control.
My BMI is over 40.
I have a weakened immune system, either from a condition I was born with or developed.
Participant Groups
The PRIME Study tests a brain-computer interface called the N1 Implant and its robotic installer, the R1 Robot. The implant records brain activity to potentially help control devices despite paralysis.
1Treatment groups
Experimental Treatment
Group I: Neuralink N1 Implant and R1 RobotExperimental Treatment2 Interventions
Implantation of the N1 Implant by the R1 Robot.
Precise Robotically Implanted Brain-Computer Interface is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Neuralink N1 Implant and R1 Robot for:
- Quadriplegia due to spinal cord injury or ALS
🇨🇦 Approved in Canada as Neuralink N1 Implant and R1 Robot for:
- Tetraparesis or tetraplegia due to cervical spinal cord injury or ALS
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Barrow Neurological InstitutePhoenix, AZ
University of MiamiMiami, FL
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Who is running the clinical trial?
Neuralink CorpLead Sponsor
References
Work toward real-time control of a cortical neural prothesis. [2022]Implantable devices that interact directly with the human nervous system have been gaining acceptance in the field of medicine since the 1960's. More recently, as is noted by the FDA approval of a deep brain stimulator for movement disorders, interest has shifted toward direct communication with the central nervous system (CNS). Deep brain stimulation (DBS) can have a remarkable effect on the lives of those with certain types of disabilities such as Parkinson's disease, Essential Tremor, and dystonia. To correct for many of the motor impairments not treatable by DBS (e.g. quadriplegia), it would be desirable to extract from the CNS a control signal for movement. A direct interface with motor cortical neurons could provide an optimal signal for restoring movement. In order to accomplish this, a real-time conversion of simultaneously recorded neural activity to an online command for movement is required. A system has been established to isolate the cellular activity of a group of motor neurons and interpret their movement-related information with a minimal delay. The real-time interpretation of cortical activity on a millisecond time scale provides an integral first step in the development of a direct brain-computer interface (BCI).
Control of a two-dimensional movement signal by a noninvasive brain-computer interface in humans. [2023]Brain-computer interfaces (BCIs) can provide communication and control to people who are totally paralyzed. BCIs can use noninvasive or invasive methods for recording the brain signals that convey the user's commands. Whereas noninvasive BCIs are already in use for simple applications, it has been widely assumed that only invasive BCIs, which use electrodes implanted in the brain, can provide multidimensional movement control of a robotic arm or a neuroprosthesis. We now show that a noninvasive BCI that uses scalp-recorded electroencephalographic activity and an adaptive algorithm can provide humans, including people with spinal cord injuries, with multidimensional point-to-point movement control that falls within the range of that reported with invasive methods in monkeys. In movement time, precision, and accuracy, the results are comparable to those with invasive BCIs. The adaptive algorithm used in this noninvasive BCI identifies and focuses on the electroencephalographic features that the person is best able to control and encourages further improvement in that control. The results suggest that people with severe motor disabilities could use brain signals to operate a robotic arm or a neuroprosthesis without needing to have electrodes implanted in their brains.
The emerging world of motor neuroprosthetics: a neurosurgical perspective. [2007]A MOTOR NEUROPROSTHETIC device, or brain computer interface, is a machine that can take some type of signal from the brain and convert that information into overt device control such that it reflects the intentions of the user's brain. In essence, these constructs can decode the electrophysiological signals representing motor intent. With the parallel evolution of neuroscience, engineering, and rapid computing, the era of clinical neuroprosthetics is approaching as a practical reality for people with severe motor impairment. Patients with such diseases as spinal cord injury, stroke, limb loss, and neuromuscular disorders may benefit through the implantation of these brain computer interfaces that serve to augment their ability to communicate and interact with their environment. In the upcoming years, it will be important for the neurosurgeon to understand what a brain computer interface is, its fundamental principle of operation, and what the salient surgical issues are when considering implantation. We review the current state of the field of motor neuroprosthetics research, the early clinical applications, and the essential considerations from a neurosurgical perspective for the future.
Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia. [2018]This review describes the rationale, early stage development, and initial human application of neural interface systems (NISs) for humans with paralysis. NISs are emerging medical devices designed to allow persons with paralysis to operate assistive technologies or to reanimate muscles based upon a command signal that is obtained directly from the brain. Such systems require the development of sensors to detect brain signals, decoders to transform neural activity signals into a useful command, and an interface for the user. We review initial pilot trial results of an NIS that is based on an intracortical microelectrode sensor that derives control signals from the motor cortex. We review recent findings showing, first, that neurons engaged by movement intentions persist in motor cortex years after injury or disease to the motor system, and second, that signals derived from motor cortex can be used by persons with paralysis to operate a range of devices. We suggest that, with further development, this form of NIS holds promise as a useful new neurotechnology for those with limited motor function or communication. We also discuss the additional potential for neural sensors to be used in the diagnosis and management of various neurological conditions and as a new way to learn about human brain function.
Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning. [2018]Implantable brain-computer interface (BCI) technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified-short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains-risks pertaining to identity, agency, and stigma-are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants.
Developing a Three- to Six-State EEG-Based Brain-Computer Interface for a Virtual Robotic Manipulator Control. [2020]We develop an electroencephalography (EEG)-based noninvasive brain-computer interface (BCI) system having short training time (15 min) that can be applied for high-performance control of robotic prosthetic systems.
An Integrated Brain-Machine Interface Platform With Thousands of Channels. [2022]Brain-machine interfaces hold promise for the restoration of sensory and motor function and the treatment of neurological disorders, but clinical brain-machine interfaces have not yet been widely adopted, in part, because modest channel counts have limited their potential. In this white paper, we describe Neuralink's first steps toward a scalable high-bandwidth brain-machine interface system. We have built arrays of small and flexible electrode "threads," with as many as 3072 electrodes per array distributed across 96 threads. We have also built a neurosurgical robot capable of inserting six threads (192 electrodes) per minute. Each thread can be individually inserted into the brain with micron precision for avoidance of surface vasculature and targeting specific brain regions. The electrode array is packaged into a small implantable device that contains custom chips for low-power on-board amplification and digitization: The package for 3072 channels occupies less than 23×18.5×2 mm3. A single USB-C cable provides full-bandwidth data streaming from the device, recording from all channels simultaneously. This system has achieved a spiking yield of up to 70% in chronically implanted electrodes. Neuralink's approach to brain-machine interface has unprecedented packaging density and scalability in a clinically relevant package.
The Reconnecting the Hand and Arm with Brain (ReHAB) Commentary on "An Integrated Brain-Machine Interface Platform With Thousands of Channels". [2020]Intracortical brain-machine interfaces are a promising technology for allowing people with chronic and severe neurological disorders that resulted in loss of function to potentially regain those functions through neuroprosthetic devices. The penetrating microelectrode arrays used in almost all previous studies of intracortical brain-machine interfaces in people had a limited recording life (potentially due to issues with long-term biocompatibility), as well as a limited number of recording electrodes with limited distribution in the brain. Significant advances are required in this array interface to deal with the issues of long-term biocompatibility and lack of distributed recordings. The Musk and Neuralink manuscript proposes a novel and potentially disruptive approach to advancing the brain-electrode interface technology, with the potential of addressing many of these hurdles. Our commentary addresses the potential advantages of the proposed approach, as well as the remaining challenges to be addressed.
Applications of brain-computer interfaces to the control of robotic and prosthetic arms. [2020]Brain-computer interfaces (BCIs) have the potential to improve the quality of life of individuals with severe motor disabilities. BCIs capture the user's brain activity and translate it into commands for the control of an effector, such as a computer cursor, robotic limb, or functional electrical stimulation device. Full dexterous manipulation of robotic and prosthetic arms via a BCI system has been a challenge because of the inherent need to decode high dimensional and preferably real-time control commands from the user's neural activity. Nevertheless, such functionality is fundamental if BCI-controlled robotic or prosthetic limbs are to be used for daily activities. In this chapter, we review how this challenge has been addressed by BCI researchers and how new solutions may improve the BCI user experience with robotic effectors.
Home Use of a Percutaneous Wireless Intracortical Brain-Computer Interface by Individuals With Tetraplegia. [2021]Individuals with neurological disease or injury such as amyotrophic lateral sclerosis, spinal cord injury or stroke may become tetraplegic, unable to speak or even locked-in. For people with these conditions, current assistive technologies are often ineffective. Brain-computer interfaces are being developed to enhance independence and restore communication in the absence of physical movement. Over the past decade, individuals with tetraplegia have achieved rapid on-screen typing and point-and-click control of tablet apps using intracortical brain-computer interfaces (iBCIs) that decode intended arm and hand movements from neural signals recorded by implanted microelectrode arrays. However, cables used to convey neural signals from the brain tether participants to amplifiers and decoding computers and require expert oversight, severely limiting when and where iBCIs could be available for use. Here, we demonstrate the first human use of a wireless broadband iBCI.
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.