BiCNS Device for Quadriplegia

(BiCNS Trial)

Recruiting at 2 trial locations

Overseen By Francesco Tenore, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Neuroleptics, Benzodiazepines, Tricyclics

Disqualifiers: Chronic psychiatric illness, Implanted devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 52 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Bidirectional Cortical Neuroprosthetic System (BiCNS) to determine its safety and effectiveness for people with quadriplegia (paralysis of all four limbs). The device involves surgical implantation to help improve control and communication for individuals with spinal cord injuries between the C4 and C6 vertebrae. The trial seeks participants who have had such an injury for over a year and do not have other serious health issues like active cancer or neurological diseases. The aim is to enhance daily life for those affected by severe paralysis. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could significantly improve the quality of life for those with similar conditions.

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 prior data suggests that this device is safe for quadriplegia?

Research has shown that the Bidirectional Cortical Neuroprosthetic System (BiCNS) is safe, based on past studies. For over ten years, these studies have used tiny electrode arrays, like those in the BiCNS, proving them safe and effective in helping people with disabilities regain certain functions.

The BiCNS requires surgery, and previous studies have met safety standards for such procedures, including approval from healthcare providers and study doctors. While all medical procedures carry some risk, testing has ensured that the BiCNS meets safety standards.

In summary, past research supports the safety of the BiCNS device for humans. It has been used safely in other studies to assist people with movement and sensory issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BiCNS device for quadriplegia because it offers a new approach by using a surgically implanted device to potentially restore function. Unlike current standard treatments that often focus on rehabilitation and symptom management, the BiCNS device targets the nervous system directly, aiming to reconnect pathways that have been disrupted. This innovative method could lead to significant improvements in mobility and independence for individuals with quadriplegia, offering hope for functional recovery that traditional therapies can't provide.

What evidence suggests that this device is effective for quadriplegia?

The BiCNS device, which participants in this trial will receive through surgical implantation, includes systems like the NeuroPort Microelectrode Array. Studies have shown that this system has been used in clinical trials for over ten years and has proven safe, showing promise in restoring movement. Research suggests that these devices can potentially improve movement in people with spinal cord injuries, such as those with quadriplegia. Success in earlier studies indicates that BiCNS might help connect the brain to muscles, allowing for some control over movement. Although more research is needed, these findings offer hope for improving the quality of life for those with severe movement difficulties. ^{1 2 3 6 7}

Who Is on the Research Team?

Nathan E Crone, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

I have been cleared for surgery by my healthcare team.

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

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 have sores or broken skin on my scalp.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Surgical implantation of BiCNS Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

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.

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]

The advanced neuroprosthesis has been successfully implanted in 4 individuals with cervical spinal cord injuries, showing significant improvements in grasp strength, range of motion, and independence in daily activities over a minimum follow-up of 16 months.

No medical complications were reported from the implanted components, indicating the system's safety and stability in providing essential grasping and reaching functions for users with tetraplegia.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

The newly developed 'neuroport' integrates an ultralow power analog CMOS chip with a silicon microelectrode array, making it suitable for brain implantable neuroengineering applications.

In tests, the neuroport successfully recorded local field potentials from rat brain slices, demonstrating its potential as a microminiaturized neural interface for chronic implantation.

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]

The newly developed microminiaturized 'neuroport' features a 16-channel CMOS amplifier with a high gain of 44 dB and low power consumption, making it suitable for implantation in the brain for neuroprosthesis applications.

As a proof-of-concept, the device successfully measured local field potentials in rat brain slices, demonstrating its capability to detect brain activity, which supports its potential as a next-generation neural interface.

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]

The Stimulus Router System (SRS) is a novel neuroprosthesis that uses implanted leads to direct electrical stimulation to target nerves, potentially improving usability by eliminating the need for an implanted stimulator.

In a case study involving a tetraplegic man, the SRS successfully restored grasp and release functions by selectively activating three target muscles through a new polarity reversing stimulation technique, enhancing the effectiveness of the system.

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]

The self-opening neural interface (SELINE) demonstrates significantly improved mechanical anchorage and stimulation stability compared to traditional planar electrodes, enhancing its effectiveness for nerve stimulation in a rat model.

Chronic implantation of SELINEs showed excellent biocompatibility, with no adverse effects on nerve organization or signs of degeneration, indicating its potential for long-term use in neural applications.

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]

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.

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]

The Networked Neuroprosthesis (NNP) is the first fully implanted modular neuroprosthetic system that can electrically activate paralyzed muscles and record biopotential signals, offering a significant advancement in restoring functionality for individuals with spinal cord injuries.

Bench testing confirmed that the NNP can generate stimulus pulses and accurately record myoelectric, temperature, and accelerometer signals, indicating its potential for various clinical applications.

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03161067

NCT03161067 | Investigation on the Bidirectional Cortical ... The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of modified versions of 510(k) cleared NeuroPort Electrode Array Systems (Blackrock ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03161067/investigation-on-the-bidirectional-cortical-neuroprosthetic-system

Investigation on the Bidirectional Cortical Neuroprosthetic ... The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of modified versions of 510(k) cleared NeuroPort Electrode Array Systems ( ...

3. reporter.nih.gov reporter.nih.gov/search/_ymjBUAOEkeMKzDNBqRyfg/project-details/10852953

Wireless Implantable COrtical Neuroprosthetic System (W ... This proposed translational study benefits from over a decade of clinical studies with microelectrode arrays, demonstrating safety and efficacy in restoring ...

4. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLVspLrShR0lHycw4xMDUxMDA1NFLS0bWEARxMQyM9C0tzI3NjHUNzEwtzYzMDMNBRyksuMTAyNrIwMzdXigUA6GgUyQ--

Save Selected The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort Microelectrode Array Systems and NeuroPort Electrodes (Sputtered Iridium Oxide ...

5. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00754-7/abstract

Invasive Brain Computer Interface for Motor Restoration in ... Clinical outcome measures were heterogeneous across all studies. Conclusions. Invasive techniques of BCI show promise for the treatment of SCI, but there is ...

6. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLVspLrShR0lHycw4xMDUxMDA1NFLS0bWEARxMQyM9C0sDE2MTHUNzU0NjIwsDMNBRyksuMTA1szQzNjVWigUA5rgUug--

Save Selected The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort Microelectrode Array Systems ... safety and efficacy compared to historical data.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8865889/

Intracortical Somatosensory Stimulation to Elicit Fingertip ... The restoration of touch to fingers and fingertips is critical to achieving dexterous neuroprosthetic control for individuals with sensorimotor dysfunction.