Investigation on the Cortical Communication (CortiCom) System
NCT03567213 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2025-07-25
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.
Conditions
- Tetraplegia
- Locked-in Syndrome
- Brainstem Stroke
- Amyotrophic Lateral Sclerosis
Interventions
- 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.
Sponsors & Collaborators
-
National Institute of Neurological Disorders and Stroke (NINDS)
collaborator NIH - lead OTHER
Principal Investigators
-
Nathan E Crone, MD · Professor of Neurology
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-14
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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