Quick Info
Status
Currently Recruiting
Estimated Enrollment
5
Phase
N/A
Treatment Type
Device: Surgical implantation of CortiCom system
Trial Type
Single Group Assignment, open-label
Primary Investigator
Nathan E Crone, MD
Contact Information
Locations
Johns Hopkins Medicine, Baltimore, 21205
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
unknown
Months Since Onset
Number of months since first symptoms of ALS.
unknown
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
unknown
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
unknown
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Update Notes
No significant updates
6/3/2019
Contact info updated
2/11/2019
No significant updates
1/30/2019
Recruitment status updated
1/14/2019
No significant updates
9/28/2018
Contact info updated
8/1/2018
Trial added
6/27/2018

Other Information

Purpose
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.
Eligibility
22 Years to 70 Years, all genders, not accepting healthy volunteers
Details
The successful adoption of brain-computer interfaces (BCIs) as assistive technologies (ATs) for disabled populations depends on the ability to elicit rapid, intuitive, and reliable control signals. To date, it is not known which sources of neural information provide the most natural and efficient means of control. This study will directly assess the efficacy of two sources of neural control signals, speech and motor cortex, for BCI control of software and devices using investigators' Cortical Communication (CortiCom) system. 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. Investigators' study will be the first to investigate the efficiency and intuitiveness of two contrasting neural control strategies for BCI: Motor imagery and speech. As the first study to chronically and simultaneously record from human speech and motor regions, this study seeks to achieve the following: - demonstrate the ability to decode intended upper extremity movements using information decoded from primary motor cortex arm/hand area; - demonstrate the ability to decode intended speech from articulatory speech cortex; and - determine the most effective and intuitive user strategies (e.g. imagined speech or imagined movement) and optimal neural sources for brain-computer interactions, The patient populations targeted in this study are amyotrophic lateral sclerosis (ALS), brainstem stroke, locked-in syndrome (LIS), and tetraplegia. Individuals within these populations may have normal cortical function and cognition while suffering from motor or combined speech and motor deficits. Based on research by colleagues, as well as investigators' own experience working with participants affected by epilepsy implanted with high density electrocorticographic grids, investigators hypothesize that long-term recording of neural activity from the targeted cortical areas may provide a new communication channel for these clinical populations. The utilization of high-channel-count (up to 128 channel) ECoG grids, in combination with simultaneous coverage of speech and motor cortex, will enable investigations into the performance of speech-mediated and motor-mediated control efficacy as applied to a variety of end effectors, such as computers, tablets, headsets for virtual or augmented reality, smart lights, televisions, and assistive technologies. Additionally, eye-tracking may be utilized in combination with neural commands to improve target selection performance and ease. Through this study, investigators will assess the performance of speech- and motor-mediated control using chronic, high-channel count ECoG grid neural implants in pursuit of a high-performing, clinically beneficial BCI assistive technology.
Collaborator(s)
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News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT03567213 (First Published: 6/26/2018)