Brain-Machine Interface for Quadriplegia
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Richard A. Andersen, PhD
Must not be taking: Steroids, Immunosuppressives
Disqualifiers: Memory problems, Psychotic illness, Diabetes, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sensory feedback.
Development of a brain-machine interface is very difficult and currently only limited technology exists in this area of neuroscience. Other studies have shown that people with high spinal cord injury still have intact brain areas capable of planning movements and grasps, but are not able to execute the movement plans. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information and sense feeling in the hand and fingers. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb.
A key part of this study is to electrically stimulate the brain by introducing a small amount of electrical current into the electrodes in the sensory area of the brain. This will result in the sensation of touch in the hand and/or fingers. This stimulation to the brain will occur when the robotic limb touches the object, thereby allowing the brain to "feel" what the robotic arm is touching.
The device being used in this study is called the Neuroport Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists of a small grid of electrodes that will be implanted in brain tissue and a small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude through the scalp to allow for connection with the computer equipment. The top portion of the pedestal has a protective cover that will be in place when the pedestal is not in use. The top of this pedestal and its protective cover will be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted in this study so three of these protective covers will be visible outside of the head. It will be possible to cover these exposed portions of the device with a hat or scarf.
The investigators hope to learn how safe and effective the Neuroport array plus stimulation is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands.
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 not be eligible to participate.
What data supports the idea that Brain-Machine Interface for Quadriplegia is an effective treatment?
The available research shows that the Brain-Machine Interface for Quadriplegia is effective in improving hand and arm functions for people with spinal cord injuries. One study found that individuals using an advanced neuroprosthesis experienced improvements in grasp strength, range of motion, and independence in daily activities. Another study demonstrated that a computerized neuromuscular stimulation system allowed patients to perform tasks like writing, eating, and drinking. These results suggest that this treatment can significantly enhance the quality of life for individuals with quadriplegia.
12345What safety data exists for the Brain-Machine Interface for Quadriplegia?
The safety data for the Brain-Machine Interface for Quadriplegia, which may be evaluated under names like Neural Prosthetic System 2 (NPS2) or Neuroport Array, is not explicitly detailed in the provided research. However, the studies discuss the challenges and improvements in neural interface systems, such as microelectrode arrays (MEAs), which are crucial components of these systems. Strategies to improve biocompatibility and reduce foreign body response (FBR) are highlighted, indicating ongoing efforts to enhance safety. The development of modular neuroprosthetic systems like the Networked Neuroprosthesis (NNP) shows successful testing in individuals with spinal cord injury, suggesting a focus on safety and functionality. Additionally, the importance of patient-centered benefit-risk assessment and regulatory processes is emphasized, indicating a structured approach to ensuring safety in neuroprosthetic development.
56789Is the treatment Neural Prosthetic System 2 (NPS2) a promising treatment for quadriplegia?
Yes, the Neural Prosthetic System 2 (NPS2) is a promising treatment for quadriplegia. It uses advanced technology to connect the brain to machines, helping restore movement and function. The system is designed to be highly efficient and can handle a lot of information, which is important for helping people with severe paralysis.
1011121314Eligibility Criteria
This trial is for individuals aged 22-65 with high spinal cord injuries resulting in quadriplegia, who can communicate in English and follow instructions. They must have a support system, be able to travel to the study site frequently, and have someone to monitor them daily post-surgery. Exclusions include memory or psychiatric disorders, poor vision, certain infections or cancers, diabetes, seizures history, MRI contraindications among others.Inclusion Criteria
I am between 22 and 65 years old.
My caregiver checks me daily for surgery complications and changes in my behavior.
I can travel up to 60 miles for the study 5 days a week.
+7 more
Exclusion Criteria
Pregnancy
I am currently undergoing chemotherapy or have active cancer.
I have diabetes.
+21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgical Implantation
Surgical procedure to implant the Neuroport Arrays and attach the percutaneous pedestal to the skull
1 week
Recovery and Initial Training
Participants recover from surgery and begin initial training to control the end effector using thought and sensory feedback
4-6 weeks
3-5 sessions per week
Ongoing Training and Evaluation
Participants engage in study sessions to control an end effector and perform reach and grasp tasks, with ongoing evaluation of control accuracy and safety
9 years
3-5 sessions per week
Follow-up
Participants are monitored for safety and effectiveness after the main training and evaluation phase
9 years
Participant Groups
The trial tests a brain-machine interface called Neural Prosthetic System 2 (NPS2), which involves implanting electrodes into the brain to allow control of devices like robotic limbs using thoughts and sensory feedback. The safety and effectiveness of this experimental device will be evaluated.
1Treatment groups
Experimental Treatment
Group I: Neural Prosthetic System 2Experimental Treatment1 Intervention
The Neural Prosthetic System 2 consists of three Neuroport Arrays, which are described in detail in the intervention description. Two of the three Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The third Neuroport Array is inserted into somatosensory cortex, specifically S1 which represents sensory feedback for the hand and fingers. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought augmented with sensory feedback via intracortical microstimulation. They will then use the end effector to perform various reach and grasp tasks.
Neural Prosthetic System 2 (NPS2) is already approved in United States for the following indications:
🇺🇸 Approved in United States as Neural Prosthetic System 2 for:
- Experimental use in clinical trials for spinal cord injury patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
California Institute of TechnologyPasadena, CA
Rancho Los Amigos National Rehabilitation CenterDowney, CA
University of Colorado Anschutz Medical CampusAurora, CO
Richard AndersenPasadena, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Richard A. Andersen, PhDLead Sponsor
University of Colorado, DenverCollaborator
University of Southern CaliforniaCollaborator
Rancho Los Amigos National Rehabilitation CenterCollaborator
University of Colorado - Anschutz Medical CampusCollaborator
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.
Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. [2007]To evaluate an implanted neuroprosthesis that allows tetraplegic users to control grasp and release in 1 hand.
Upper limb functions regained in quadriplegia: a hybrid computerized neuromuscular stimulation system. [2006]A new, computerized neuromuscular stimulation system was applied to the upper limbs of two patients with complete quadriplegia below the C4 level. The stimulation-generated movements were integrated and augmented by residual, voluntary shoulder girdle movements and mechanical splinting. Up to 12 muscles were stimulated individually with high-resolution surface electrodes; coordination and control of the stimulation was effected by microcomputer. Simple vocal commands to the computer triggered preprogrammed hand prehensions, arm motion, and other functions, giving the patient complete control over the system. In pilot clinical trials of six weeks, writing, eating, and drinking, including picking up and replacing the pen or cup, were achieved.
Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis. [2019]To test the efficacy and safety of the NESS Handmaster neuroprosthesis with subjects with C5 or C6 tetraplegia.
Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. [2022]Implantable motor neuroprostheses can restore functionality to individuals with neurological disabilities by electrically activating paralyzed muscles in coordinated patterns. The typical design of neuroprosthetic systems relies on a single multi-use device, but this limits the number of stimulus and sensor channels that can be practically implemented. To address this limitation, a modular neuroprosthesis, the "Networked Neuroprosthesis" (NNP), was developed. The NNP system is the first fully implanted modular neuroprosthesis that includes implantation of all power, signal processing, biopotential signal recording, and stimulating components. This paper describes the design of stimulation and recording modules, bench testing to verify stimulus outputs and appropriate filtering and recording, and validation that the components function properly while implemented in persons with spinal cord injury. The results of system testing demonstrated that the NNP was functional and capable of generating stimulus pulses and recording myoelectric, temperature, and accelerometer signals. Based on the successful design, manufacturing, and testing of the NNP System, multiple clinical applications are anticipated.
A Critical Review of Microelectrode Arrays and Strategies for Improving Neural Interfaces. [2023]Though neural interface systems (NISs) can provide a potential solution for mitigating the effects of limb loss and central nervous system damage, the microelectrode array (MEA) component of NISs remains a significant limiting factor to their widespread clinical applications. Several strategies can be applied to MEA designs to increase their biocompatibility. Herein, an overview of NISs and their applications is provided, along with a detailed discussion of strategies for alleviating the foreign body response (FBR) and abnormalities seen at the interface of MEAs and the brain tissue following MEA implantation. Various surface modifications, including natural/synthetic surface coatings, hydrogels, and topography alterations, have shown to be highly successful in improving neural cell adhesion, reducing gliosis, and increasing MEA longevity. Different MEA surface geometries, such as those seen in the Utah and Michigan arrays, can help alleviate the resultant FBR by reducing insertion damage, while providing new avenues for improving MEA recording performance and resolution. Increasing overall flexibility of MEAs as well as reducing their stiffness is also shown to reduce MEA induced micromotion along with FBR severity. By combining multiple different properties into a single MEA, the severity and duration of an FBR postimplantation can be reduced substantially.
Neuroprosthetics and the science of patient input. [2019]Safe and effective neuroprosthetic systems are of great interest to both DARPA and CDRH, due to their innovative nature and their potential to aid severely disabled populations. By expanding what is possible in human-device interaction, these devices introduce new potential benefits and risks. Therefore patient input, which is increasingly important in weighing benefits and risks, is particularly relevant for this class of devices. FDA has been a significant contributor to an ongoing stakeholder conversation about the inclusion of the patient voice, working collaboratively to create a new framework for a patient-centered approach to medical device development. This framework is evolving through open dialogue with researcher and patient communities, investment in the science of patient input, and policymaking that is responsive to patient-centered data throughout the total product life cycle. In this commentary, we will discuss recent developments in patient-centered benefit-risk assessment and their relevance to the development of neural prosthetic systems.
Technology transfer of neuroprosthetic devices. [2011]Despite long development periods for neuroprosthetic devices, the numbers in clinical use or clinical trials are rising, with an estimated 3,000 systems in use today. As they gain experience with the regulatory approval process, developers are learning to conduct research to best prepare for transfer of technology to industry. The track record of the first motor prosthesis to be approved by the United States Food and Drug Administration contains important lessons for a company planning to undergo the regulatory process. Throughout the development of a neuroprosthesis, the capabilities and preferences of the customers who will use it (physicians, surgeons, therapists, and end-users) should be sought out and used in device design. When a device has reached clinical application, particular attention is needed to maximize both the population who will use it and each individual's degree of use (optimal, partial, reluctant). Identification of person-technology mismatches can help to select training strategies and other interventions that can be applied to ensure a good rehabilitation outcome.
Neural Prosthetics:A Review of Empirical vs. Systems Engineering Strategies. [2023]Implantable electrical interfaces with the nervous system were first enabled by cardiac pacemaker technology over 50 years ago and have since diverged into almost all of the physiological functions controlled by the nervous system. There have been a few major clinical and commercial successes, many contentious claims, and some outright failures. These tend to be reviewed within each clinical subspecialty, obscuring the many commonalities of neural control, biophysics, interface materials, electronic technologies, and medical device regulation that they share. This review cites a selection of foundational and recent journal articles and reviews for all major applications of neural prosthetic interfaces in clinical use, trials, or development. The hard-won knowledge and experience across all of these fields can now be amalgamated and distilled into more systematic processes for development of clinical products instead of the often empirical (trial and error) approaches to date. These include a frank assessment of a specific clinical problem, the state of its underlying science, the identification of feasible targets, the availability of suitable technologies, and the path to regulatory and reimbursement approval. Increasing commercial interest and investment facilitates this systematic approach, but it also motivates projects and products whose claims are dubious.
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.
Baseplate for two-stage cranial mounting of BMI connectors. [2013]Intracortical electrode arrays provide the best spatial and temporal resolution signals for brain-machine interfaces. Wireless technologies are being developed to handle this information capacity, but currently the only means to deliver neural information from the implant to a signal processing unit is by a physical connection starting at a skull-mounted connector. The failure rate of the attachment of these connectors is significant. In this study we report an improvement to the traditional connectors.
Flexible polyimide-based intracortical electrode arrays with bioactive capability. [2009]The promise of advanced neuroprosthetic systems to significantly improve the quality of life for a segment of the deaf, blind, or paralyzed population hinges on the development of an efficacious, and safe, multichannel neural interface for the central nervous system. The candidate implantable device that is to provide such an interface must exceed a host of exacting design parameters. We present a thin-film, polyimide-based, multichannel intracortical Bio-MEMS interface manufactured with standard planar photo-lithographic CMOS-compatible techniques on 4-in silicon wafers. The use of polyimide provides a mechanically flexible substrate which can be manipulated into unique three-dimensional designs. Polyimide also provides an ideal surface for the selective attachment of various important bioactive species onto the device in order to encourage favorable long-term reactions at the tissue-electrode interface. Structures have an integrated polyimide cable providing efficient contact points for a high-density connector. This report details in vivo and in vitro device characterization of the biological, electrical and mechanical properties of these arrays. Results suggest that these arrays could be a candidate device for long-term neural implants.
Wireless, high-bandwidth recordings from non-human primate motor cortex using a scalable 16-Ch implantable microsystem. [2021]A multitude of neuroengineering challenges exist today in creating practical, chronic multichannel neural recording systems for primate research and human clinical application. Specifically, a) the persistent wired connections limit patient mobility from the recording system, b) the transfer of high bandwidth signals to external (even distant) electronics normally forces premature data reduction, and c) the chronic susceptibility to infection due to the percutaneous nature of the implants all severely hinder the success of neural prosthetic systems. Here we detail one approach to overcome these limitations: an entirely implantable, wirelessly communicating, integrated neural recording microsystem, dubbed the Brain Implantable Chip (BIC).
Evaluation of command sources for a high tetraplegia neural prosthesis. [2020]One of the issues involved in the development of a neural prosthesis for high tetraplegia is that of an appropriate command interface between the user and prosthetic. With high levels of impairment come low levels of available voluntary actions suitable for issuing commands. Three potential command interfaces were investigated for their applicability to commanding endpoint position of a robot arm, as a proxy to a stimulated paralyzed arm. Head orientation as a command source was explored using both direct servo drive and gated ramp algorithms. EMG signals with a gated ramp algorithm from muscles in the face were also investigated as a potential command source. The information transfer rate (ITR) of all three command interfaces were evaluated using a 3D Fitts Law task. The resulting information transfer rate of the EMG interface was 0.55 Bits/sec, while both head orientation interfaces resulted in ITRs of 0.49 Bits/sec each.