RecruitingNot ApplicableNCT03567213

Investigation on the Cortical Communication (CortiCom) System


Sponsor

Johns Hopkins University

Enrollment

3 participants

Start Date

Dec 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the CortiCom brain-computer interface system in people with severe paralysis. A brain-computer interface (BCI) works by recording electrical signals directly from the brain's motor cortex — the area that controls movement — and translating those signals into commands for a computer, communication device, or robotic arm. For people with conditions like ALS, spinal cord injury, or locked-in syndrome who have lost virtually all motor function, BCIs could restore the ability to communicate or interact with the environment. The CortiCom system involves surgically implanting small electrode arrays on the surface of the brain to record neural signals. Participants are trained to use their thoughts to control the interface over months of sessions. You may be eligible if: - You are between 22 and 70 years old - You have tetraplegia (quadriplegia), brainstem stroke, ALS, or locked-in syndrome - Your condition has been stable for at least one year - You are able to give informed consent and communicate reliably (e.g., via eye movement) - You are able to travel to the study site up to three days per week You may NOT be eligible if: - You have implanted devices incompatible with MRI (pacemakers, deep brain stimulators, cochlear implants) - You are pregnant or planning to become pregnant - You have active cancer or a serious infection - You have had a prior cranioplasty - You have a history of substance or alcohol dependence in the past 2 years - You have significant cognitive impairment or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESurgical implantation of CortiCom system

Implantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.


Locations(1)

Johns Hopkins Medicine

Baltimore, Maryland, United States

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NCT03567213


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