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NCT03567213: CortiCom
Investigation on the Cortical Communication (CortiCom) System
NA trial testing Surgical implantation of CortiCom system in Tetraplegia in 3 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 3 |
| Start date | 14 December 2021 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Surgical implantation of CortiCom system
Conditions studied
- Tetraplegia — all drugs for Tetraplegia →
- Locked-in Syndrome — all drugs for Locked-in Syndrome →
- Brainstem Stroke — all drugs for Brainstem Stroke →
- Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
Sponsor
Johns Hopkins University
Who can join
Adults 22 to 70, any sex, with Tetraplegia or Locked-in Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Online speech synthesis using a chronically implanted brain-computer interface in an individual with ALS.
Angrick M, Luo S, Rabbani Q, Candrea DN, et al · · 2024 · cited 53× · PMID 38671062 · DOI 10.1038/s41598-024-60277-2 -
Stable Decoding from a Speech BCI Enables Control for an Individual with ALS without Recalibration for 3 Months.
Luo S, Angrick M, Coogan C, Candrea DN, et al · · 2023 · cited 50× · PMID 37875404 · DOI 10.1002/advs.202304853 -
Brain-Computer Interfaces in Neurorecovery and Neurorehabilitation.
Young MJ, Lin DJ, Hochberg LR. · · 2021 · cited 35× · PMID 33742433 · DOI 10.1055/s-0041-1725137 -
Stability of ECoG high gamma signals during speech and implications for a speech BCI system in an individual with ALS: a year-long longitudinal study.
Wyse-Sookoo K, Luo S, Candrea D, Schippers A, et al · · 2024 · cited 12× · PMID 38925110 · DOI 10.1088/1741-2552/ad5c02 -
A click-based electrocorticographic brain-computer interface enables long-term high-performance switch scan spelling.
Candrea DN, Shah S, Luo S, Angrick M, et al · · 2024 · cited 9× · PMID 39433597 · DOI 10.1038/s43856-024-00635-3 -
Real-time detection of spoken speech from unlabeled ECoG signals: a pilot study with an ALS participant.
Angrick M, Luo S, Rabbani Q, Joshi S, et al · · 2025 · cited 1× · PMID 40972658 · DOI 10.1088/1741-2552/ae0965 -
Stable speech BCI performance during slow progression of ALS: A longitudinal ECoG study
Ouyang Z, Walmsley K, Luo S, Tippett D, et al · · 2026 · DOI 10.21203/rs.3.rs-9156039/v1 -
Longitudinal study of gesture decoding in a clinical trial participant with ALS
Candrea DN, Angrick M, Luo S, Ganji R, et al · · 2025 · DOI 10.1101/2025.09.26.25335804
Verify or expand the search:
- PubMed search for NCT03567213
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03567213 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
- Last refreshed: 25 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03567213.
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