5 Participants Needed

BiCNS Device for Quadriplegia

(BiCNS Trial)

Recruiting at 2 trial locations
MA
PA
NE
FT
Overseen ByFrancesco Tenore, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications that affect neuroplasticity, such as neuroleptics, benzodiazepines, and tricyclic antidepressants. If you are on these medications, you may need to stop taking them to participate.

What data supports the effectiveness of the BiCNS treatment for quadriplegia?

Research on similar neuroprosthetic systems shows that they can improve grasp strength, range of motion, and independence in daily activities for individuals with spinal cord injuries. Additionally, neuroprostheses have been shown to restore motor functions and increase standing times in patients with spinal cord injuries, suggesting potential benefits for the BiCNS treatment.12345

Is the BiCNS Device for Quadriplegia safe for human use?

The available research primarily involves testing in animal models and technical evaluations, with no specific human safety data provided. The studies focus on the design and testing of components like microelectrodes and stimulation systems, which are intended to be safe within certain limits, but human safety data is not explicitly mentioned.16789

How does the BiCNS treatment for quadriplegia differ from other treatments?

The BiCNS treatment is unique because it uses a brain implantable system that combines microelectrodes and microelectronics to record and stimulate neural activity, potentially allowing for direct brain control of devices. This approach is different from traditional treatments that may rely on external devices or muscle-based stimulation, offering a more integrated and potentially more effective solution for restoring function in quadriplegia.12378

What is the purpose of this trial?

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.

Research Team

NE

Nathan E Crone, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals with C4-C6 tetraplegia, not due to neurodegenerative disease or active cancer. They must have had the injury for over a year, expect to live more than 5 years, and be able to travel to the study site regularly. Participants need stable support systems and cannot be on narcotics or have other major health issues that could interfere.

Inclusion Criteria

You are expected to live for more than 5 years.
Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study
I have been cleared for surgery by my healthcare team.
See 9 more

Exclusion Criteria

Your vision is no worse than 20/30 after using corrective lenses.
Inability to undergo MRI or anticipated need for an MRI during the study period
I rely on a machine to help me breathe.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Surgical implantation of the Bidirectional Cortical Neuroprosthetic System (BiCNS) in participants

1 week
1 visit (in-person)

Treatment

Participants undergo long-term neural recording and intracortical microstimulation (ICMS) for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BiCNS
Trial Overview The BiCNS device is being tested for safety and effectiveness in people with quadriplegia. It includes various components like electrode arrays, signal processors, and stimulators aimed at restoring some neurological functions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Surgical implantation of BiCNSExperimental Treatment1 Intervention

BiCNS is already approved in United States, Canada, China for the following indications:

🇺🇸
Approved in United States as NeuroPort Microelectrode Array System for:
  • Temporary (<30 days) recording and monitoring of brain electrical activity
🇨🇦
Approved in Canada as NeuroPort Microelectrode Array System for:
  • Chronic and subchronic stimulation and recording of human neural activity
🇨🇳
Approved in China as NeuroPort Microelectrode Array System for:
  • Chronic and subchronic stimulation and recording of human neural activity

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Findings from Research

The newly designed 96-channel stimulation system safely drives activated iridium oxide microelectrodes by maximizing charge-injection capacity while adhering to safe limits, which is crucial for preventing damage to the electrodes.
This system is set to be utilized in animal experiments for intracortical neural stimulation, specifically in the context of a visual prosthesis project, indicating its potential application in restoring vision.
A 96-channel neural stimulation system for driving AIROF microelectrodes.Hu, Z., Troyk, P., Cogan, S.[2020]
The Brain Implantable Chip (BIC) is a novel, fully implantable neural recording system designed to address major challenges in neuroengineering, such as limited patient mobility and susceptibility to infection from traditional wired systems.
By enabling wireless communication, the BIC allows for high-bandwidth signal transfer without the need for external connections, potentially improving the effectiveness and safety of chronic neural recording in both primate research and human clinical applications.
Wireless, high-bandwidth recordings from non-human primate motor cortex using a scalable 16-Ch implantable microsystem.Borton, DA., Song, YK., Patterson, WR., et al.[2021]
The 16-channel implanted neuroprosthesis demonstrated a remarkable 600% increase in standing times for individuals with spinal cord injuries compared to previous muscle-based electrode systems.
The stability of the nerve-cuff electrodes used for stimulating the femoral nerve indicates a reliable mechanism for facilitating knee extension during standing and transfers.
Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation.Fisher, LE., Miller, ME., Bailey, SN., et al.[2018]

References

A 96-channel neural stimulation system for driving AIROF microelectrodes. [2020]
Wireless, high-bandwidth recordings from non-human primate motor cortex using a scalable 16-Ch implantable microsystem. [2021]
Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation. [2018]
First permanent human implant of the Stimulus Router System, a novel neuroprosthesis: preliminary testing of a polarity reversing stimulation technique. [2020]
An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. [2019]
A three-dimensional self-opening intraneural peripheral interface (SELINE). [2015]
Development of a chipscale integrated microelectrode/microelectronic device for brain implantable neuroengineering applications. [2019]
A microelectrode/microelectronic hybrid device for brain implantable neuroprosthesis applications. [2019]
Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. [2022]
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