Implantation of brain-computer interface for communication in ALS, quadriplegia, and Locked In Syndrome (CortiCom Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByNathan E Crone, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.
Is the CortiCom System a promising treatment for ALS?Yes, the CortiCom System is a promising treatment for ALS because it uses brain-computer interface technology to help people with ALS communicate, even in late stages of the disease. This technology can improve their quality of life by allowing them to express their thoughts and needs.13568
What safety data exists for the Brain-Computer Interface for ALS?The safety data for the Brain-Computer Interface, which may include systems like the CortiCom System and others, is supported by several studies. A study on a wireless neuroprosthesis for epilepsy patients demonstrated successful wireless transmission of brain signals with excellent quality, indicating potential for long-term use. Another study on chronic subdural electrode implantation in beagles showed minimal tissue reaction and no adverse events over six months, suggesting good biocompatibility. Additionally, a study on soft ECoG arrays in minipigs reported successful long-term implantation and functionality, supporting the safety of these devices. These studies collectively suggest that the technology has been evaluated for safety in both human and animal models, showing promising results for long-term implantation and minimal adverse effects.247910
What data supports the idea that Brain-Computer Interface for ALS is an effective treatment?The available research shows that Brain-Computer Interfaces (BCIs) can help people with ALS, especially in late stages, by improving their ability to communicate. One study highlights the long-term stability of a BCI system for home use, which suggests it can be a reliable tool for communication. However, another study points out that current BCIs are not widely used due to technological and user limitations, and they may not perform well for patients in the most severe stages of ALS. Overall, while BCIs show promise, their effectiveness can vary, and they are not yet a perfect solution for everyone with ALS.13568
Do I need to stop 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 anti-coagulant medications, it may be medically contraindicated to stop them during surgery, which could affect your eligibility.
Eligibility Criteria
This trial is for adults aged 22-70 with conditions like Locked-In Syndrome, ALS, or tetraplegia due to brainstem stroke or injury. Participants must have had their condition for at least a year and be able to communicate through eye movement. People with active infections, epilepsy, substance abuse history, MRI incompatibility, certain medical conditions or surgeries that affect implant safety are excluded.Inclusion Criteria
I have severe paralysis or muscle weakness in all four limbs, possibly with major speech difficulties.
I have had a stroke or injury that affected my brainstem.
Do you have Locked-In Syndrome (normal cognition but impaired communication due to muscle weakness)?
I have tetraplegia or quadriplegia due to a spinal cord injury.
I have a condition that affects my speech and makes my arms or legs weak.
I have been diagnosed with ALS or motor neuron disease.
Participant Groups
The CortiCom system involves surgically placing up to two electrode grids on the brain's surface over areas controlling speech and arm movements. This device aims to help people with severe paralysis communicate better by translating brain signals into speech or text.
1Treatment groups
Experimental Treatment
Group I: Surgical implantation of the CortiCom systemExperimental Treatment1 Intervention
CortiCom System is already approved in United States for the following indications:
🇺🇸 Approved in United States as CortiCom System for:
- Investigational use for speech and upper extremity movement encoding
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Johns Hopkins MedicineBaltimore, MD
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
A brain-computer interface tool to assess cognitive functions in completely paralyzed patients with amyotrophic lateral sclerosis. [2009]Brain-computer interface methodology based on self-regulation of slow-cortical potentials (SCPs) of the EEG was used to assess cognitive abilities of two late-stage ALS patients.
Hermetic electronic packaging of an implantable brain-machine-interface with transcutaneous optical data communication. [2020]Future brain-computer-interfaces (BCIs) for severely impaired patients are implanted to electrically contact the brain tissue. Avoiding percutaneous cables requires amplifier and telemetry electronics to be implanted too. We developed a hermetic package that protects the electronic circuitry of a BCI from body moisture while permitting infrared communication through the package wall made from alumina ceramic. The ceramic package is casted in medical grade silicone adhesive, for which we identified MED2-4013 as a promising candidate.
A brain-computer interface based on self-regulation of gamma-oscillations in the superior parietal cortex. [2014]Brain-computer interface (BCI) systems are often based on motor- and/or sensory processes that are known to be impaired in late stages of amyotrophic lateral sclerosis (ALS). We propose a novel BCI designed for patients in late stages of ALS that only requires high-level cognitive processes to transmit information from the user to the BCI.
A fully integrated wireless system for intracranial direct cortical stimulation, real-time electrocorticography data transmission, and smart cage for wireless battery recharge. [2021]Wireless transmission of cortical signals is an essential step to improve the safety of epilepsy procedures requiring seizure focus localization and to provide chronic recording of brain activity for Brain Computer Interface (BCI) applications. Our group developed a fully implantable and externally rechargeable device, able to provide wireless electrocorticographic (ECoG) recording and cortical stimulation (CS). The first prototype of a wireless multi-channel very low power ECoG system was custom-designed to be implanted on non-human primates. The device, named ECOGIW-16E, is housed in a compact hermetically sealed Polyether ether ketone (PEEK) enclosure, allowing seamless battery recharge. ECOGIW-16E is recharged in a wireless fashion using a special cage designed to facilitate the recharge process in monkeys and developed in accordance with guidelines for accommodation of animals by Council of Europe (ETS123). The inductively recharging cage is made up of nylon and provides a thoroughly novel experimental setting on freely moving animals. The combination of wireless cable-free ECoG and external seamless battery recharge solves the problems and shortcomings caused by the presence of cables leaving the skull, providing a safer and easier way to monitor patients and to perform ECoG recording on primates. Data transmission exploits the newly available Medical Implant Communication Service band (MICS): 402-405 MHz. ECOGIW-16E was implanted over the left sensorimotor cortex of a macaca fascicularis to assess the feasibility of wireless ECoG monitoring and brain mapping through CS. With this device, we were able to record the everyday life ECoG signal from a monkey and to deliver focal brain stimulation with movement elicitation.
Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing. [2019]For patients with amyotrophic lateral sclerosis (ALS) who are suffering from severe communication or motor problems, brain-computer interfaces (BCIs) can improve the quality of life and patient autonomy. However, current BCI systems are not as widely used as their potential and patient demand would let assume. This underutilization is a result of technological as well as user-based limitations but also of the comparatively poor performance of currently existing BCIs in patients with late-stage ALS, particularly in the locked-in state.
Stability of a chronic implanted brain-computer interface in late-stage amyotrophic lateral sclerosis. [2020]We investigated the long-term functional stability and home use of a fully implanted electrocorticography (ECoG)-based brain-computer interface (BCI) for communication by an individual with late-stage Amyotrophic Lateral Sclerosis (ALS).
A Wireless Neuroprosthesis for Patients with Drug-refractory Epilepsy: A Proof-of-Concept Study. [2020]Objective Acute or protracted cortical recording may be necessary for patients with drug-refractory epilepsy to identify the ictogenic regions before undergoing resection. Currently, these invasive recording techniques present certain limitations, one of which is the need for cables connecting the recording electrodes placed in the intracranial space with external devices displaying the recorded electrocorticographic signals. This equates to a direct connection between the sterile intracranial space with the non-sterile environment. Due to the increasing likelihood of infections with time, subdural grids are typically removed a few days after implantation, a limiting factor in localizing the epileptogenic zone if seizures are not frequent enough to be captured within this time-frame. Furthermore, patients are bound to stay in the hospital, connected by the wires to the recording device, thus increasing substantially the treatment costs. To address some of the current shortcomings of invasive monitoring, we developed a neuroprosthesis made of a subdural silicone grid connected to a wireless transmitter allowing prolonged electrocorticografic recording and direct cortical stimulation. This device consists of a silicone grid with 128-platinum/iridium contacts, connected to an implantable case providing wireless recording and stimulation. The case also houses a wirelessly rechargeable battery for chronic long-term implants. We report the results of the first human proof-of-concept trial for wireless transmission of electrocorticographic recordings using a device suited for long-term implantation in three patients with drug-refractory epilepsy. Methods Three patients with medically refractory epilepsy underwent the temporary intraoperative placement of the subdural grid connected to the wireless device for recording and transmission of electrocorticographic signals for a duration of five minutes before the conventional recording electrodes were placed or the ictal foci were resected. Results Wireless transmission of brain signals was successfully achieved. The wireless electrocorticographic signal was judged of excellent quality by a blinded neurophysiologist. Conclusions This preliminary experience reports the first successful placement of a wireless electrocorticographic recording device in humans. Long-term placement for prolonged wireless electrocorticographic recording in epilepsy patients will be the next step.
Brain-computer interfaces for people with amyotrophic lateral sclerosis. [2021]A brain-computer interface (BCI) records and extracts features from brain signals, and translates these features into commands that can replace, restore, enhance, supplement, or improve natural CNS outputs. As demonstrated in the other chapters of this book, the focus of the work of the last three decades of BCI research has been the replacement, restoration, or improvement of diminished or lost function in people with CNS disease or injury including those with amyotrophic lateral sclerosis (ALS). Due in part to the desire to conduct controlled studies, and, in part, to the complexity of BCI technology, most of this work has been carried out in laboratories with healthy controls or with limited numbers of potential consumers with a variety of diagnoses under supervised conditions. The intention of this chapter is to describe the growing body of BCI research that has included people with amyotrophic lateral sclerosis (ALS). People in the late stages of ALS can lose all voluntary control, including the ability to communicate; and while recent research has provided new insights into underlying mechanisms, ALS remains a disease with no cure. As a result, people with ALS and their families, caregivers, and advocates have an active interest in both the current and potential capabilities of BCI technology. The focus of BCI research for people with ALS is on communication, and this topic is well covered elsewhere in this volume. This chapter focuses on the efforts dedicated to make BCI technology useful to people with ALS in their daily lives with a discussion of how researchers, clinicians, and patients must become partners in that process.
Minimal Tissue Reaction after Chronic Subdural Electrode Implantation for Fully Implantable Brain-Machine Interfaces. [2021]There is a growing interest in the use of electrocorticographic (ECoG) signals in brain-machine interfaces (BMIs). However, there is still a lack of studies involving the long-term evaluation of the tissue response related to electrode implantation. Here, we investigated biocompatibility, including chronic tissue response to subdural electrodes and a fully implantable wireless BMI device. We implanted a half-sized fully implantable device with subdural electrodes in six beagles for 6 months. Histological analysis of the surrounding tissues, including the dural membrane and cortices, was performed to evaluate the effects of chronic implantation. Our results showed no adverse events, including infectious signs, throughout the 6-month implantation period. Thick connective tissue proliferation was found in the surrounding tissues in the epidural space and subcutaneous space. Quantitative measures of subdural reactive tissues showed minimal encapsulation between the electrodes and the underlying cortex. Immunohistochemical evaluation showed no significant difference in the cell densities of neurons, astrocytes, and microglia between the implanted sites and contralateral sites. In conclusion, we established a beagle model to evaluate cortical implantable devices. We confirmed that a fully implantable wireless device and subdural electrodes could be stably maintained with sufficient biocompatibility in vivo.
Subdural Soft Electrocorticography (ECoG) Array Implantation and Long-Term Cortical Recording in Minipigs. [2023]Neurological impairments and diseases can be diagnosed or treated using electrocorticography (ECoG) arrays. In drug-resistant epilepsy, these help delineate the epileptic region to resect. In long-term applications such as brain-computer interfaces, these epicortical electrodes are used to record the movement intention of the brain, to control the robotic limbs of paralyzed patients. However, current stiff electrode grids do not answer the need for high-resolution brain recordings and long-term biointegration. Recently, conformable electrode arrays have been proposed to achieve long-term implant stability with high performance. However, preclinical studies for these new implant technologies are needed to validate their long-term functionality and safety profile for their translation to human patients. In this context, porcine models are routinely employed in developing medical devices due to their large organ sizes and easy animal handling. However, only a few brain applications are described in the literature, mostly due to surgery limitations and integration of the implant system on a living animal. Here, we report the method for long-term implantation (6 months) and evaluation of soft ECoG arrays in the minipig model. The study first presents the implant system, consisting of a soft microfabricated electrode array integrated with a magnetic resonance imaging (MRI)-compatible polymeric transdermal port that houses instrumentation connectors for electrophysiology recordings. Then, the study describes the surgical procedure, from subdural implantation to animal recovery. We focus on the auditory cortex as an example target area where evoked potentials are induced by acoustic stimulation. We finally describe a data acquisition sequence that includes MRI of the whole brain, implant electrochemical characterization, intraoperative and freely moving electrophysiology, and immunohistochemistry staining of the extracted brains. This model can be used to investigate the safety and function of novel design of cortical prostheses; mandatory preclinical study to envision translation to human patients.