Investigation on the Cortical Communication (CortiCom) System (CortiCom)
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|ClinicalTrials.gov Identifier: NCT03567213|
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tetraplegia Locked-in Syndrome Brainstem Stroke Amyotrophic Lateral Sclerosis||Device: Surgical implantation of CortiCom system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Investigation on the Cortical Communication (CortiCom) System|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2024|
|Experimental: Surgical implantation of the CortiCom system||
Device: Surgical implantation of CortiCom system
Implantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.
- Time to device explantation [ Time Frame: 26 weeks ]This study outcome will be considered successful if the device is not explanted during the 26-week period of the study. Explantation of the device prior to the completion of the 26-week period implies that the device is putting the subject at risk (e.g. through a serious infection at the implantation site) and therefore must be removed.
- Success rate in controlling the brain computer interface, i.e. ratio of successful trials to total trials. [ Time Frame: 26 weeks ]One or more participants demonstrates successful use of the CortiCom system in which motor and/or speech neural signals can be decoded to provide control signals for software and devices. Efficacy is assessed in terms of accuracy, i.e. how often the participant is able to select a desired target.
- Speed of brain-computer interface control, i.e. time to complete successful trials (in seconds). [ Time Frame: 26 weeks ]One or more participants demonstrates successful use of the CortiCom system in which motor and/or speech neural signals can be decoded to provide control signals for software and devices. Efficacy is therefore also assessed in terms of how long it takes to select the target.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567213
|Contact: Nathan E Crone, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Medicine||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Nathan E Crone, MD 410-955-6772 email@example.com|
|Principal Investigator: Nathan E Crone, MD|
|Principal Investigator:||Nathan E Crone, MD||Professor of Neurology|