Investigation on the Bidirectional Cortical Neuroprosthetic System

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03161067
Status
Recruiting
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Conditions

  • Quadriplegia
  • Tetraplegia

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • BiCNS — DEVICE
    Surgical implantation

Study Details

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.

Key Dates

Start date
Aug 1, 2017
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Surgical implantation of BiCNS

Primary Outcome Measure

Safety of BiCNS: The device is not explanted during 52-week study [ Time Frame: 52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of NeurologyBaltimoreMaryland21287
Nathan E Crone, MD
[email protected]
410-955-9441

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By research site
Department of Neurology· Baltimore, MD

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