Investigation on the Cortical Communication (CortiCom) System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorJohns Hopkins University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)
Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment
Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.
22-70 years
Disqualifiers
Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.
Suicide attempt or persistent suicidal ideation within the past 12 months.
Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants.
History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months
Trial design
Design model
Single group
Treatments tested in this trial
Surgical implantation of CortiCom system
DeviceImplantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Surgical implantation of the CortiCom systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to device explantation
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.
Time frame
26 weeksSecondary outcomes
1
Success rate in controlling the brain computer interface, i.e. ratio of successful trials to total trials.
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.
Time frame
26 weeks2
Speed of brain-computer interface control, i.e. time to complete successful trials (in seconds).
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.
Time frame
26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov