BiCNS Device for Quadriplegia

(BiCNS Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Nathan E Crone, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Neuroleptics, Benzodiazepines, Tricyclics

Disqualifiers: Chronic psychiatric illness, Implanted devices, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 2 3 6 7}

Research Team

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.

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.

Trial 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 (Neuroprosthetic Device)

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

Group I: Surgical implantation of BiCNS Experimental Treatment 1 Intervention

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

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

Research Locations Nearby Select from list below to view details:

Department of Neurology Baltimore, MD

Department of Physical Medicine and Rehabilitation Baltimore, MD

Johns Hopkins Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2366

Patients Recruited

15,160,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 96-channel neural stimulation system for driving AIROF microelectrodes. Hu, Z., Troyk, P., Cogan, S.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation. Fisher, LE., Miller, ME., Bailey, SN., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First permanent human implant of the Stimulus Router System, a novel neuroprosthesis: preliminary testing of a polarity reversing stimulation technique. Gan, LS., Ravid, EN., Kowalczewski, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. Peckham, PH., Kilgore, KL., Keith, MW., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a chipscale integrated microelectrode/microelectronic device for brain implantable neuroengineering applications. Song, YK., Patterson, WR., Bull, CW., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microelectrode/microelectronic hybrid device for brain implantable neuroprosthesis applications. Patterson, WR., Song, YK., Bull, CW., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. Makowski, N., Campean, A., Lambrecht, J., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A three-dimensional self-opening intraneural peripheral interface (SELINE). Cutrone, A., Del Valle, J., Santos, D., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

A 96-channel neural stimulation system for driving AIROF microelectrodes. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Wireless, high-bandwidth recordings from non-human primate motor cortex using a scalable 16-Ch implantable microsystem. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

First permanent human implant of the Stimulus Router System, a novel neuroprosthesis: preliminary testing of a polarity reversing stimulation technique. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Development of a chipscale integrated microelectrode/microelectronic device for brain implantable neuroengineering applications. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A microelectrode/microelectronic hybrid device for brain implantable neuroprosthesis applications. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A three-dimensional self-opening intraneural peripheral interface (SELINE). [2015]