Investigation on the Bidirectional Cortical Neuroprosthetic System
NCT03161067 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2025-09-09
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.
Conditions
- Tetraplegia
- Quadriplegia
Interventions
- DEVICE
-
BiCNS
Surgical implantation
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Nathan E Crone, MD · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-01
- Primary Completion
- 2026-07-31
- Completion
- 2027-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
NCT05035823 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
NCT07109804 ·Status: RECRUITING ·Phase: NA
-
Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
NCT02163876 ·Status: TERMINATED ·Phase: PHASE2
-
Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia
NCT01849822 ·Status: COMPLETED ·Phase: NA
-
Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation
NCT02006433 ·Status: COMPLETED ·Phase: NA
-
Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation
NCT00370773 ·Status: TERMINATED ·Phase: PHASE4
-
Exoskeletons for Spinal Cord Injury: A Feasibility Study
NCT01943669 ·Status: UNKNOWN ·Phase: PHASE4
-
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
NCT03680872 ·Status: RECRUITING ·Phase: NA
-
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
NCT05041114 ·Status: WITHDRAWN ·Phase: NA
-
BCI-Assisted SCS-EXS for Gait Optimization
NCT06939660 ·Status: RECRUITING ·Phase: NA
-
Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation
NCT05665998 ·Status: RECRUITING ·Phase: NA
-
A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis
NCT01119001 ·Status: COMPLETED ·Phase: NA
-
Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries
NCT00004445 ·Status: COMPLETED ·Phase: NA
-
Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait
NCT03053791 ·Status: RECRUITING ·Phase: NA
-
Exoskeleton Training on Balance Control and Turning in Ambulation in Individuals With Incomplete Spinal Cord Injury
NCT06971510 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
EMPOWER Early Feasibility Study: Non-invasive BCI to Control a Wheelchair for People With Paralysis
NCT06169696 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes
NCT01923662 ·Status: COMPLETED ·Phase: NA
-
A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
NCT01123148 ·Status: COMPLETED ·Phase: NA
-
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
NCT05724173 ·Status: RECRUITING ·Phase: NA
-
Spine and Brain Stimulation for Movement Recovery After Cervical Spinal Cord Injury
NCT06867809 ·Status: RECRUITING ·Phase: NA
-
Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
NCT03594266 ·Status: COMPLETED ·Phase: NA
-
Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions
NCT02592291 ·Status: RECRUITING ·Phase: NA
-
A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface(BCI)System NEO in Patients With Tetraplegia
NCT06990412 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
NCT04193709 ·Status: COMPLETED ·Phase: NA
-
A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
NCT06097000 ·Status: RECRUITING ·Phase: NA