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NCT03567213 · ClinicalTrials.gov registry record · NA
Investigation on the Cortical Communication (CortiCom) System
A NA study of Amyotrophic Lateral Sclerosis and Tetraplegia, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT03567213: Recruiting NA study of Amyotrophic Lateral Sclerosis and Tetraplegia, sponsored by Johns Hopkins University.
NCT03567213 is a NA study of Amyotrophic Lateral Sclerosis and Tetraplegia that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 3 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03567213, a NA study of Amyotrophic Lateral Sclerosis and Tetraplegia, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Surgical implantation of CortiCom system
Study Locations (1)
Maryland
- Johns Hopkins Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What NCT03567213 shows while recruiting
NCT03567213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Surgical implantation of CortiCom system is the first listed.
NCT03567213 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03567213 about?
NCT03567213 is a clinical study titled "Investigation on the 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, fo...
What is the current status of trial NCT03567213?
This trial is currently recruiting. It is a NA study. The enrollment target is 3 participants. The study started on 2021-12-14. Estimated completion is 2026-08-31.
What conditions does trial NCT03567213 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, Tetraplegia, Locked-in Syndrome, Brainstem Stroke.
What interventions are being tested in trial NCT03567213?
The interventions under investigation include: Surgical implantation of CortiCom system (DEVICE).
Who is sponsoring clinical trial NCT03567213?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03567213 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03567213's enrollment target sits among peer trials
3 97th of 102 higher than 5 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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