Neuroprosthesis Device for Spinal Cord Injury

(GRANND Trial)

Overseen by Anne Bryden, PhD, OTR/L

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: MetroHealth Medical Center

Disqualifiers: MS, Diabetes, Cervical spine pathology, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing an implantable device called NP-UE that helps people with cervical spinal cord injuries move their arms and hands. The device sends signals to nerves to make muscles move and senses attempts to move, helping restore hand function. The NP-UE device is part of a second-generation system that helps control hand grasp and elbow extension in individuals with cervical spinal cord injury.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

What data supports the effectiveness of the treatment Networked Neuroprosthesis Device for spinal cord injury?

The Networked Neuroprosthesis (NNP) system has been successfully designed, manufactured, and tested, showing it can generate stimulus pulses and record important signals in people with spinal cord injury. Additionally, neuroprostheses that stimulate paralyzed muscles have been shown to restore functions like standing and grasping in individuals with spinal cord injuries, suggesting potential benefits of the NNP system. ^{1 2 3 4 5}

Is the Neuroprosthesis Device for Spinal Cord Injury safe for humans?

The Neuroprosthesis Device, including its variations like the Networked Neuroprosthesis (NNP), has been tested in humans with spinal cord injuries and shown to be safe. Studies report no medical complications from the implanted components, and the devices have been used successfully for over 20 years, demonstrating their durability and safety. ^{1 4 6 7 8}

How is the Networked Neuroprosthesis Device treatment different from other treatments for spinal cord injury?

The Networked Neuroprosthesis Device is unique because it is a fully implanted modular system that can stimulate and record signals from paralyzed muscles, allowing for more precise and coordinated muscle activation compared to traditional single-device neuroprostheses. This modular approach enables the restoration of multiple functions and offers a more integrated and potentially more effective solution for individuals with spinal cord injuries. ^{1 2 3 5 7}

Research Team

Anne Bryden, PhD, OTR/L

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

This trial is for individuals over 16 years old with a stable cervical spinal cord injury (SCI) at levels C1-C7 and AIS grades A, B, or C. They must have certain upper extremity muscle strength and be medically stable. Excluded are those with other neurological conditions, active infections, pregnancy, co-existing cervical spine issues, or involvement in conflicting studies.

Inclusion Criteria

My spinal cord injury is in my neck and is classified as severe to moderate.

I had nerve surgery on my arm and have been stable for over a year.

My health condition is currently stable.

Exclusion Criteria

I have a history of blood clotting disorders, HIV, heart/lung disease, slow heart rate, uncontrolled nerve system reactions, or COPD.

I have a neurological condition like MS or diabetes affecting my nerves.

Progressive SCI

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Assessment

Participants receive the implanted networked neuroprosthetic system and undergo initial functional training and assessment

3 months

Multiple visits for implantation and initial assessments

Post-implant Follow-up

Participants are monitored for safety and effectiveness with assessments at 3, 6, and 12 months post-implant

12 months

Assessments at 3, 6, and 12 months post-implant

Treatment Details

Interventions

• Networked Neuroprosthesis Device (Neuroprosthetic Device)

Trial Overview The Networked Neuroprosthesis Device - Upper Extremity (NP-UE) is being tested for safety and effectiveness in helping people with cervical SCI to regain grasp-release functions of their hands.

Participant Groups

Group I: Experimental: Intervention - implant neuroprosthesis Experimental Treatment 1 Intervention

Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment.

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Dr. Christine Alexander-Rager

MetroHealth Medical Center

Chief Executive Officer

MD from The Ohio State University College of Medicine & Public Health

Dr. Bernard Boulanger

MetroHealth Medical Center

Chief Medical Officer since 2020

MD from Case Western Reserve University

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Jordan Gladman

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Medical Officer

MD from Harvard Medical School

Walter J. Koroshetz

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Executive Officer since 2007

MD from the University of Chicago

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Eric W. Kaler

Case Western Reserve University

Chief Executive Officer since 2021

PhD in Chemical Engineering from the University of Minnesota

Stanton L. Gerson

Case Western Reserve University

Chief Medical Officer since 2020

MD from Harvard Medical School

Findings from Research

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]

In a study involving 12 participants with motor complete spinal cord injury, significant electrical activity was detected in 89% of the muscles below the injury level, indicating that these muscles can potentially serve as command sources for neuroprostheses.

At least two muscles from each participant showed enough activity to be considered viable command signals, suggesting that even in cases of clinically complete spinal cord injury, some voluntary control may still exist and can be harnessed for restoring movement functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel command signal for motor neuroprosthetic control. Moss, CW., Kilgore, KL., Peckham, PH.[2021]

Combining neuromuscular electrical stimulation (NMES) with robotic devices can enhance the accuracy and repeatability of arm and hand movements in individuals with tetraplegia, potentially restoring functional independence after spinal cord injuries.

Current hybrid NMES-robotic systems face challenges in usability outside clinical settings due to their complexity, highlighting the need for improvements in technology, user interfaces, and standardized performance assessments to facilitate real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of methods for achieving upper limb movement following spinal cord injury through hybrid muscle stimulation and robotic assistance. Dunkelberger, N., Schearer, EM., O'Malley, MK.[2020]

The NESS Handmaster neuroprosthesis was found to be safe and effective for improving hand function in individuals with C5 or C6 tetraplegia, with all 7 participants successfully completing daily living tasks after using the device.

Participants showed significant improvements in grip strength (from 0.57 N to 16.5 N) and finger motion (from 0 cm to 8.4 cm), with no safety issues reported, and 6 out of 7 subjects rated their performance as 'excellent' after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis. Alon, G., McBride, K.[2019]

Implanted neuroprostheses that electrically stimulate paralyzed muscles can significantly improve functional abilities in individuals with spinal cord injuries and strokes, enabling activities like standing, stepping, and grasping.

These devices are designed for chronic use, offering reliable and low-maintenance solutions that are generally well-accepted by patients, highlighting their potential for long-term rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implanted stimulators for restoration of function in spinal cord injury. Bhadra, N., Kilgore, KL., Peckham, PH.[2019]

Neuroprosthetic systems are being developed to assist severely disabled individuals, highlighting the importance of balancing their innovative benefits with potential risks.

The FDA is actively promoting a patient-centered approach in the development of these devices, emphasizing the need for patient input in assessing the benefits and risks throughout the product's life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprosthetics and the science of patient input. Benz, HL., Civillico, EF.[2019]

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]

Neuroprosthetic systems for upper extremity use in spinal cord injured individuals have been successfully implanted for over 20 years, demonstrating significant long-term durability.

The implanted components, especially the stimulating electrodes and leads, have shown a high level of durability, which is crucial for devices expected to function for potentially over 50 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty year experience with implanted neuroprostheses. Kilgore, KL., Peckham, P., Keith, MW.[2020]

References

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

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

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

A novel command signal for motor neuroprosthetic control. [2021]

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

A review of methods for achieving upper limb movement following spinal cord injury through hybrid muscle stimulation and robotic assistance. [2020]

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

Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Implanted stimulators for restoration of function in spinal cord injury. [2019]

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

Neuroprosthetics and the science of patient input. [2019]

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

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

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

Twenty year experience with implanted neuroprostheses. [2020]