NCT03161067: BiCNS

Investigation on the Bidirectional Cortical Neuroprosthetic System

Recruiting now NA Last updated 9 September 2025

What this trial tests

NA trial testing BiCNS in Tetraplegia in 5 participants. Currently enrolling.

Timeline

1 August 2017

Primary endpoint
31 July 2026

30 September 2027

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	5
Start date	1 August 2017
Primary completion	31 July 2026
Estimated completion	30 September 2027
Sites	1 location across United States

Drugs / interventions tested

• BiCNS

Conditions studied

• Tetraplegia — all drugs for Tetraplegia →
• Quadriplegia — all drugs for Quadriplegia →

Sponsor

Johns Hopkins University

Who can join

Adults 22 to 65, any sex, with Tetraplegia or Quadriplegia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort Microelectrode Array Systems and NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The goals of this early feasibility study consist of safety and efficacy evaluations of this device.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intracortical Somatosensory Stimulation to Elicit Fingertip Sensations in an Individual With Spinal Cord Injury.
   Fifer MS, McMullen DP, Osborn LE, Thomas TM, et al · · 2022 · cited 67× · PMID 34880087 · DOI 10.1212/wnl.0000000000013173
2. Shared Control of Bimanual Robotic Limbs With a Brain-Machine Interface for Self-Feeding.
   Handelman DA, Osborn LE, Thomas TM, Badger AR, et al · · 2022 · cited 28× · PMID 35837250 · DOI 10.3389/fnbot.2022.918001
3. Use of Invasive Brain-Computer Interfaces in Pediatric Neurosurgery: Technical and Ethical Considerations.
   Bergeron D, Iorio-Morin C, Bonizzato M, Lajoie G, et al · · 2023 · cited 26× · PMID 37116888 · DOI 10.1177/08830738231167736
4. Quantifying physical degradation alongside recording and stimulation performance of 980 intracortical microelectrodes chronically implanted in three humans for 956-2130 days.
   Bjånes DA, Kellis S, Nickl R, Baker B, et al · · 2025 · cited 12× · PMID 40037510 · DOI 10.1016/j.actbio.2025.02.030
5. Subthreshold intracortical microstimulation of human somatosensory cortex enhances tactile sensitivity.
   Osborn LE, Christie B, McMullen DP, Arriola V, et al · · 2025 · cited 1× · PMID 40216307 · DOI 10.1016/j.brs.2025.03.021
6. Characteristics and stability of sensorimotor activity driven by isolated-muscle group activation in a human with tetraplegia.
   Nickl RW, Anaya MA, Thomas TM, Fifer MS, et al · · 2022 · cited 1× · PMID 35725741 · DOI 10.1038/s41598-022-13436-2