Neuralink Brain-Computer Interface for Quadriplegia (CAN-PRIME Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Neuralink Corp
No Placebo Group
Trial Summary
What is the purpose of this trial?The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.
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.
Is the Neuralink N1 Implant and R1 Robot a promising treatment for quadriplegia?Yes, the Neuralink N1 Implant and R1 Robot is a promising treatment for quadriplegia. It offers hope by using brain signals to control devices, potentially restoring movement and independence for people with severe paralysis.4561113
What safety data exists for the Neuralink Brain-Computer Interface for Quadriplegia?The provided research does not contain specific safety data for the Neuralink Brain-Computer Interface or its related components such as the N1 Implant, Link, or R1 Robot. The studies focus on other topics like spinal cord injury models, neuronavigation systems, and neuromonitoring in scoliosis surgery, none of which directly address the safety of Neuralink's technology.37101215
What data supports the idea that Neuralink Brain-Computer Interface for Quadriplegia is an effective treatment?The available research shows that brain-computer interfaces, like the Neuralink N1 Implant, have been effective in restoring movement in cases of paralysis. For example, in a study with a 21-year-old male with complete quadriplegia, the interface helped restore hand grasp control with high accuracy, allowing him to perform tasks like lifting and transferring objects. Additionally, in non-human primates, a similar interface restored leg movement after spinal cord injury, enabling them to walk on a treadmill. These results suggest that the Neuralink Brain-Computer Interface could be a promising treatment for quadriplegia, offering a way to regain some motor functions.128914
Eligibility Criteria
This trial is for individuals with severe movement disabilities due to conditions like Motor Neuron Disease, Spinal Cord Injury, or ALS. Participants should have limited arm and leg mobility (tetraparesis or tetraplegia). Specific eligibility details are not provided but typically include age, health status, and the severity of paralysis.Inclusion Criteria
I have had severe quadriplegia for at least a year without improvement.
Exclusion Criteria
I have a history of diabetes that is hard to control.
My BMI is over 40.
I have a weakened immune system, either from a condition or inherited.
I have a history of seizures or epilepsy that is hard to control.
My brain MRI shows bleeding, tumor, or abnormal structure.
Participant Groups
The CAN-PRIME Study tests Neuralink's N1 Implant and R1 Robot. The implant goes into the skull and connects to brain threads placed by the robot. It aims to see if people can control external devices using their thoughts.
1Treatment groups
Experimental Treatment
Group I: CAN-PRIME: Precise Robotically Implanted Brain-Computer InterfaceExperimental Treatment2 Interventions
Open label
N1 Implant is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Neuralink N1 Implant for:
- Quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS)
🇨🇦 Approved in Canada as Neuralink N1 Implant for:
- Tetraparesis or tetraplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University Health NetworkToronto, Canada
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Who is running the clinical trial?
Neuralink CorpLead Sponsor
University Health Network, TorontoCollaborator
References
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.
Comparative study of application accuracy of two frameless neuronavigation systems: experimental error assessment quantifying registration methods and clinically influencing factors. [2021]This study aimed at comparing the accuracy of two commercial neuronavigation systems. Error assessment and quantification of clinical factors and surface registration, often resulting in decreased accuracy, were intended. Active (Stryker Navigation) and passive (VectorVision Sky, BrainLAB) neuronavigation systems were tested with an anthropomorphic phantom with a deformable layer, simulating skin and soft tissue. True coordinates measured by computer numerical control were compared with coordinates on image data and during navigation, to calculate software and system accuracy respectively. Comparison of image and navigation coordinates was used to evaluate navigation accuracy. Both systems achieved an overall accuracy of
Brain-Computer Interface-FES Integration: Towards a Hands-free Neuroprosthesis Command System. [2022]This paper presents a critical review of brain-computer interfaces (BCIs) and their potential for neuroprosthetic applications. Summaries are provided for the command interface requirements of hand grasp, multijoint, and lower extremity neuroprostheses, and the characteristics of various BCIs are discussed in relation to these requirements. The review highlights the current limitations of BCIs and areas of research that need to be addressed to enhance BCI-FES integration.
Advances in neuroprosthetic learning and control. [2021]Significant progress has occurred in the field of brain-machine interfaces (BMI) since the first demonstrations with rodents, monkeys, and humans controlling different prosthetic devices directly with neural activity. This technology holds great potential to aid large numbers of people with neurological disorders. However, despite this initial enthusiasm and the plethora of available robotic technologies, existing neural interfaces cannot as yet master the control of prosthetic, paralyzed, or otherwise disabled limbs. Here I briefly discuss recent advances from our laboratory into the neural basis of BMIs that should lead to better prosthetic control and clinically viable solutions, as well as new insights into the neurobiology of action.
Training to use a commercial brain-computer interface as access technology: a case study. [2017]This case study describes how an individual with spastic quadriplegic cerebral palsy was trained over a period of four weeks to use a commercial electroencephalography (EEG)-based brain-computer interface (BCI).
Diagnostic accuracy of evoked potentials for functional impairment after contusive spinal cord injury in adult rats. [2018]Iatrogenic spinal cord injury (SCI) is a cause of potentially debilitating post-operative neurologic complications. Currently, intra-operative neurophysiological monitoring (IONM) via somatosensory evoked potentials and motor-evoked potentials is used to detect and prevent impending SCI. However, no empirically validated interventions exist to halt the progression of iatrogenic SCI once it is detected. This is in part due to the lack of a suitable translational model that mimics the circumstances surrounding iatrogenic SCI detected via IONM. Here, we evaluate a model of simulated contusive iatrogenic SCI detected via IONM in adult female Sprague-Dawley rats. We show that transient losses of somatosensory evoked potentials responses are 88.24% sensitive (95% confidence interval [CI] 63.53-98.20) and 80% specific (95% CI 51.91-95.43) for significant functional impairment following simulated iatrogenic SCI. Similarly, we show that transient losses in motor-evoked potentials responses are 70.83% sensitive (95% CI 48.91-87.33) and 100% specific (95% CI 62.91-100.00) for significant functional impairment following simulated iatrogenic SCI. These results indicate that our model is a suitable replica of the circumstances surrounding clinical iatrogenic SCI.
A brain-spine interface alleviating gait deficits after spinal cord injury in primates. [2022]Spinal cord injury disrupts the communication between the brain and the spinal circuits that orchestrate movement. To bypass the lesion, brain-computer interfaces have directly linked cortical activity to electrical stimulation of muscles, and have thus restored grasping abilities after hand paralysis. Theoretically, this strategy could also restore control over leg muscle activity for walking. However, replicating the complex sequence of individual muscle activation patterns underlying natural and adaptive locomotor movements poses formidable conceptual and technological challenges. Recently, it was shown in rats that epidural electrical stimulation of the lumbar spinal cord can reproduce the natural activation of synergistic muscle groups producing locomotion. Here we interface leg motor cortex activity with epidural electrical stimulation protocols to establish a brain-spine interface that alleviated gait deficits after a spinal cord injury in non-human primates. Rhesus monkeys (Macaca mulatta) were implanted with an intracortical microelectrode array in the leg area of the motor cortex and with a spinal cord stimulation system composed of a spatially selective epidural implant and a pulse generator with real-time triggering capabilities. We designed and implemented wireless control systems that linked online neural decoding of extension and flexion motor states with stimulation protocols promoting these movements. These systems allowed the monkeys to behave freely without any restrictions or constraining tethered electronics. After validation of the brain-spine interface in intact (uninjured) monkeys, we performed a unilateral corticospinal tract lesion at the thoracic level. As early as six days post-injury and without prior training of the monkeys, the brain-spine interface restored weight-bearing locomotion of the paralysed leg on a treadmill and overground. The implantable components integrated in the brain-spine interface have all been approved for investigational applications in similar human research, suggesting a practical translational pathway for proof-of-concept studies in people with spinal cord injury.
A rodent brain-machine interface paradigm to study the impact of paraplegia on BMI performance. [2020]Most brain machine interfaces (BMI) focus on upper body function in non-injured animals, not addressing the lower limb functional needs of those with paraplegia. A need exists for a novel BMI task that engages the lower body and takes advantage of well-established rodent spinal cord injury (SCI) models to study methods to improve BMI performance.
Retrospective Analysis of EMG-evoked Potentials in Cortical Bone Trajectory Pedicle Screws. [2019]This is a retrospective analysis of electromyographic (EMG) stimulation thresholds of 64 cortical bone trajectory (CBT) screws.
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.
Learning Curve for Robot-Assisted Percutaneous Pedicle Screw Placement in Thoracolumbar Surgery. [2023]Retrospective review of an initial cohort of consecutive patients undergoing robot-assisted pedicle screw placement.
A wearable neural interface for detecting and decoding attempted hand movements in a person with tetraplegia. [2020]We are developing a wearable neural interface based on high-density surface electromyography (HDEMG) for detecting and decoding signals from spared motor units in the forearms of people with tetraplegia after spinal cord injury (SCI). A lightweight, form-fitting garment containing 150 disc electrodes and covering the entire forearm was used to map the myoelectric activity of forearm muscles during a wide range of voluntary tasks of a person with chronic tetraplegia after SCI (C5 motor and C6 sensory American Spinal Injury Association Impairment Scale B spinal cord injury). Despite exhibiting no overt finger motion, myoelectric signals were detectable for attempted movements of individual digits and were highly discriminable. Motor unit decomposition was used to identify the activity of >30 motor neurons, active specifically during rotation, pronation of the wrist (4 units), and flexion of the elbow joint (7 units), and during attempted movements of individual hand digits (1-5 units). In addition, we performed a neural connectivity analysis based on the power of the common oscillations of the identified motor neurons in the delta (~5Hz), alpha (~6-12 Hz), and beta bands (~15-30 Hz). This analysis showed clear common synaptic inputs to the identified motor neurons in all the analyzed frequency bands. This neural interface offers a new potential for the control of assistive technologies, whereby the motor neurons spared after SCI may serve as a direct readout of motor intent that allows proportional control over several distinct degrees of freedom. Moreover, this framework can be used to study the reorganization and recovery of spinal networks after injury and rehabilitation.
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.
Feasibility, Safety and Reliability of Surgeon-Directed Transcranial Motor Evoked Potentials Monitoring in Scoliosis Surgery. [2023](1) Background: Neuromonitoring is essential in corrective surgery for scoliosis. Our aim was to assess the feasibility, safety and reliability of "surgeon-directed" intraoperative monitoring transcranial motor evoked potentials (MEP) of patients. (2) Methods: A retrospective single-center study of a cohort of 190 scoliosis surgeries, monitored by NIM ECLIPSE (Medtronic), between 2017 and 2021. Girls (144) and boys (46) (mean age of 15 years) were included. There were 149 idiopathic and 41 secondary scoliosis. The monitoring consisted of stimulating the primary motor cortex to record the MEP with muscular recording on the thenar, vastus lateralis, tibialis anterior and adductor hallucis muscles. (3) Results: The monitoring data was usable in 180 cases (94.7%), with 178 true negatives, no false negatives and one false positive. There was one true positive case. The predictive negative value was 100%. The monitoring data was unusable in 10 cases (i.e., three idiopathic and seven secondary scoliosis). (4) Conclusions: Simplified transcranial MEP monitoring known as "surgeon-directed module" is usable, safety and reliable in surgery for moderate scoliosis. It is feasible in 95% of cases with a negative predictive value of 100%.