NCT03161067

Investigation on the Bidirectional Cortical Neuroprosthetic System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This proposed early feasibility, investigator-initiated study is led by Dr. Nathan E. Crone, M.D. at Johns Hopkins Medicine (JHM). The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of modified versions of 510(k) cleared NeuroPort Electrode Array Systems (Blackrock Microsystems, Inc., Salt Lake City, UT) as well as a neurostimulator module (CereStim R96) for long term neural recording and intracortical microstimulation (ICMS) of the brain. The BiCNS is termed bidirectional because it permits both the recording of information from the brain for controlling an end effector device, as well as enabling information regarding that end effector to be returned to the brain in the form of ICMS. "End effector" in this sense is used to mean a physical or virtual device designed to interact with its (physical or virtual) environment. Electrode arrays will be implanted in the brain in pairs, with a pair comprising a recording array and a stimulating array. A total of six NeuroPort arrays, consisting of three array pairs, will be implanted in each study participant. Each pair will consist of an array implanted in primary motor cortex (M1) for recording and an array implanted in primary sensory cortex (S1) for stimulation and/or recording; both arrays in each pair will be connected to a single percutaneous pedestal as an external interface. In each participant, two such array pairs will be implanted in the hand/arm area of M1 and S1 in the dominant brain hemisphere (e.g., the left hemisphere for a right-handed individual). A third pair will be implanted in the hand/arm area of M1 and S1 in non-dominant hemisphere (e.g. right hemisphere for a right handed-individual). The recording arrays implanted in M1 are the NeuroPort microelectrode arrays with platinum (Pt) tips (K070272), whereas the ICMS arrays implanted in S1 are NeuroPort microelectrode arrays with Sputtered Iridium-Oxide Film (SIROF) tips (K110010). The study has Investigational Device Exemption (IDE) approval from FDA to implant these devices for 52 weeks (plus/minus 2 weeks).

Conditions

• Tetraplegia
• Quadriplegia

Interventions

Type	Name	Description
DEVICE	BiCNS	Surgical implantation

Timeline

• Start date: 2017-08-01
• Primary completion: 2026-07-31
• Completion: 2027-09-30
• First posted: 2017-05-19
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study