CRS Array Brain-Machine Interface for Spinal Cord Injury

(CRS-BMI Trial)

Recruiting at 1 trial location

Overseen By Olivia L Campbell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael Boninger

Must not be taking: Sedatives, Anti-epileptics, Steroids, Immunosuppressants

Disqualifiers: Visual impairment, Serious disease, Active infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new brain-machine interface designed to help individuals with spinal cord injuries or similar conditions regain some hand function. The treatment uses tiny devices called CRS Arrays (also known as Utah Array or Michigan Probe), implanted in the brain to record and stimulate brain activity. It targets individuals with limited or no use of one or both hands due to spinal cord injuries, strokes, or amputations. Participants should be at least a year past their injury and live within two hours of the research site or be willing to travel weekly. The trial aims to ensure the safety and effectiveness of this device in assisting users with everyday tasks. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could transform lives.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that affect motor coordination or cognitive ability, you may not be eligible to participate.

What prior data suggests that the CRS Arrays are safe for use in brain-machine interfaces?

Previous studies have shown that devices like the CRS Arrays are safe. Research on a similar device, the Utah Array, has supported its safety in clinical settings. The Utah Array has successfully recorded brain activity and stimulated the brain in people with spinal cord injuries.

These devices are designed for placement in the brain to record signals and stimulate areas to restore movement. Although the Utah Array has a strong history of being well-tolerated, some users may experience minor side effects, such as discomfort or irritation at the implantation site.

While previous studies are promising, individual experiences can vary. Participants should discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CRS Arrays Brain-Machine Interface is unique because it taps directly into the brain's neural activity using implanted microelectrodes. This approach offers a new way to help individuals with spinal cord injuries, potentially allowing them to control devices with their thoughts alone. Researchers are excited about this treatment because it could restore movement or communication abilities in a way that current options, like physical therapy or assistive devices, can't. By directly interfacing with the brain, the CRS Arrays aim to create more natural and seamless interactions, potentially revolutionizing rehabilitation for spinal cord injury patients.

What evidence suggests that the CRS Arrays are effective for spinal cord injury?

Research shows that CRS Arrays, tiny devices placed in the brain, can both record and stimulate brain activity. Studies have found that these arrays can help people with spinal cord injuries regain movement by capturing brain signals and turning them into actions. This trial will involve participants implanted with CRS Arrays to record neural activity, as there is no control group. Other studies have successfully used this technology, showing promise for long-term use in helping people control their movements again. Early results suggest significant progress toward making this a practical system for restoring movement. The goal of using CRS Arrays is to improve the quality of life for those with spinal cord injuries by helping them better control their movements. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael L Boninger, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults aged 22-70 with severe hand function loss due to specific injuries or conditions, able to follow study procedures and communicate in English. They must have a stable support system, live within 2 hours of the University of Pittsburgh, and not have worsening neurological status. Excluded are those with visual impairments, active infections, excessive alcohol consumption, certain diseases that affect participation ability, metal implants incompatible with MRI scans, uncontrolled diabetes or seizures.

Inclusion Criteria

You are expected to live for more than 18 months.

I understand the study's goals and can follow simple instructions.

I have reliable support for daily skin and pedestal site care.

Exclusion Criteria

You have trouble seeing things on a computer screen even with glasses.

You have metal implants that would prevent you from having an fMRI scan.

You have any kind of implantable device like a pacemaker, cochlear implant, or defibrillator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Training

Participants undergo implantation of microelectrodes and initial training to use the brain-machine interface

4-8 weeks

Long-term Evaluation

Participants are evaluated for safety and efficacy of the brain-machine interface over a 12-month period

12 months

Follow-up

Participants are monitored for safety and effectiveness after the main evaluation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CRS Arrays

Trial Overview The trial tests the safety and effectiveness of CRS Arrays (microelectrodes) implanted in the brain. These devices record motor cortex activity and stimulate sensory cortex to potentially restore movement control or sensation in individuals with severe upper limb disabilities.

How Is the Trial Designed?

Group I: Brain-Machine Interface Users Experimental Treatment 1 Intervention

All participants enrolled in the study who meet eligibility criteria will be individuals implanted with microelectrodes in their brain to record neural activity. There is no control group.

CRS Arrays is already approved in United States for the following indications:

Approved in United States as Utah Array for:

• Motor brain-machine interfaces for paralyzed patients
• Clinical investigations of intracortical brain-machine interface technology

Who Is Running the Clinical Trial?

Michael Boninger

Lead Sponsor

Trials

3

Recruited

230+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Carnegie Mellon University

Collaborator

Trials

80

Recruited

540,000+

Sinai Health System

Collaborator

Trials

26

Recruited

11,900+

Published Research Related to This Trial

The use of a microelectrode array during spine surgery allows for high-resolution mapping of spinal cord activity, providing detailed spatiotemporal information that traditional intraoperative neuromonitoring (IONM) methods cannot achieve.

This advanced technique enables the recording of neural responses at lower stimulation currents and can detect postoperative evoked potentials, potentially improving the safety and effectiveness of surgical procedures by offering better electrophysiological markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constructing 2D maps of human spinal cord activity and isolating the functional midline with high-density microelectrode arrays. Russman, SM., Cleary, DR., Tchoe, Y., et al.[2022]

Carbon fiber microelectrode bundles were successfully developed and implanted in the spinal cord of experimental animals, allowing for effective in vivo recording of neural signals, including single spikes.

The removal of a small portion of the coating at the tips of the electrodes improved the signal-to-noise ratio, and the design showed minimal tissue encapsulation, indicating good biocompatibility and potential for long-term use in neural recordings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon Fiber Electrodes for in Vivo Spinal Cord Recordings. Cetinkaya, E., Gok, S., Sahin, M.[2020]

In a comprehensive analysis of over 6000 datasets from 17 rhesus macaques and 2 human subjects, Utah electrode arrays (UEAs) demonstrated an average lifespan of 622 days for reliable recordings, with some lasting over 1000 days and even up to 9 years.

The study found that human implants generally lasted longer than those in non-human primates, and that the type of metallization on the electrode tip (iridium oxide vs. platinum) significantly influenced the quality and longevity of the recordings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longevity and reliability of chronic unit recordings using the Utah, intracortical multi-electrode arrays. Sponheim, C., Papadourakis, V., Collinger, JL., et al.[2022]

This study highlights significant variability in the duration of chronic studies using microelectrode arrays (MEAs) across different animal species, particularly in rodents, which are commonly used for such research.

The active electrode yield (AEY) in rodent models showed a linear decay over time with commercially-available devices, emphasizing the need for consistent benchmarks to evaluate the performance of new MEA technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracortical Microelectrode Array Unit Yield under Chronic Conditions: A Comparative Evaluation. Usoro, JO., Sturgill, BS., Musselman, KC., et al.[2021]

Neuroprosthetics are advancing with new microelectrode arrays that can selectively stimulate neurons and record their activity, potentially restoring lost neural functions.

However, the long-term effectiveness and safety of these implanted microelectrodes in humans are still uncertain, particularly regarding the tissue damage they may cause, which needs to be managed for successful clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute human brain responses to intracortical microelectrode arrays: challenges and future prospects. Fernández, E., Greger, B., House, PA., et al.[2021]

In a study involving a rhesus macaque, it was found that implanted Utah arrays led to a 63% reduction in the number of neurons surrounding the electrodes compared to control areas, indicating significant neuron loss due to the tissue response.

Despite some material damage observed, such as tip breakage and cracks, the arrays remained largely intact, suggesting that improvements in electrode design, like using smaller or softer probes, could enhance tissue response and improve neural recording capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utah array characterization and histological analysis of a multi-year implant in non-human primate motor and sensory cortices. Patel, PR., Welle, EJ., Letner, JG., et al.[2023]

Microelectrode arrays, traditionally used for studying the brain, can also effectively record and stimulate the spinal cord, particularly in the corticospinal tract of animal models.

This innovative application of microelectrodes may lead to new therapeutic approaches for treating severe spinal cord injuries by enhancing our understanding of spinal cord function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized stimulation and recording in the spinal cord with microelectrode arrays. Arle, JE., Shils, JL., Malik, WQ.[2020]

The study developed a parylene-based microelectrode array implant for the epidural spinal cord, which was tested on rats with hindlimb paralysis due to spinal cord injury, showing recovery of stepping functionality over an eight-week period.

This advanced implant offers greater precision in stimulation compared to traditional wire-based devices, potentially enhancing our understanding of spinal cord recovery mechanisms and improving rehabilitation strategies for spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A PARYLENE-BASED MICROELECTRODE ARRAY IMPLANT FOR SPINAL CORD STIMULATION IN RATS. Nandra, MS., Lavrov, IA., Edgerton, VR., et al.[2021]

The new intermediary mounting plate design for skull-mounted connectors significantly reduces the failure rate of attachments in brain-machine interfaces, as tested in three non-human primates.

Key features of the design, such as wide legs for force distribution and a two-stage fixation process, enhance stability and promote osseointegration, leading to improved outcomes for subjects in intracortical recording experiments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseplate for two-stage cranial mounting of BMI connectors. McMorland, AJ., Velliste, M.[2013]

Recent advancements in penetrating microelectrode arrays, such as Utah electrode arrays, have shown promise in recording motor commands from the central nervous system, which could lead to improved therapies for motor disorders.

These microelectrode arrays can also evoke sensory perceptions in the peripheral nervous system, suggesting their potential to enhance the quality of life for patients with neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of penetrating neural interfaces and Utah Electrode Array technologies. Normann, RA., Fernandez, E.[2018]

The development of a miniaturized brain-machine-spinal cord interface (BMSI) shows promise for restoring mobility in individuals with spinal cord injuries by converting neural signals into electrical stimuli for the spinal cord.

In a proof-of-concept study with anesthetized rats, the BMSI successfully activated distinct muscle patterns through intraspinal microstimulation, demonstrating the potential for real-time control of movement based on brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical control of intraspinal microstimulation: Toward a new approach for restoration of function after spinal cord injury. Shahdoost, S., Frost, S., Dunham, C., et al.[2020]

The study evaluated the chronic performance of 16-channel Utah electrode arrays in rat motor cortex over 6 months, revealing a significant decline in recording capability, with single-unit active electrode yield dropping from 52.8% to 13.4%.

The findings indicated that the main issues affecting performance were abiotic failures, such as mechanical wire breakage and degradation of the electrode materials, which could impact the reliability of these devices for long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic recording and electrochemical performance of Utah microelectrode arrays implanted in rat motor cortex. Black, BJ., Kanneganti, A., Joshi-Imre, A., et al.[2019]

Brain-machine interfaces (BMIs) have the potential to restore motor and sensory functions in amputees and patients with spinal cord injuries by allowing voluntary control over prosthetic limbs or paralyzed muscles.

Recent advancements in decoding motor intentions from brain activity and providing sensory feedback through electrical stimulation show promise for these invasive interfaces, but significant challenges still need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring sensorimotor function through intracortical interfaces: progress and looming challenges. Bensmaia, SJ., Miller, LE.[2022]

Citations

1. withpower.com withpower.com/trial/phase-brain-stem-infarctions-11-2013-d5cc6

CRS Array Brain-Machine Interface for Spinal Cord Injury The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01894802

NCT01894802 | Cortical Recording and Stimulating Array ... The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor ...

3. deepblue.lib.umich.edu deepblue.lib.umich.edu/handle/2027.42/149940

Feasibility of Using the Utah Array for Long-Term Fully ... These results represent significant progress towards a clinically-viable system for motor restoration in people suffering from spinal cord injury. Show more ...

4. asia-spinalinjury.org asia-spinalinjury.org/wp-content/uploads/2016/07/SCOPE-Rehab-Technology-TrialsTable-2016.06.02.pdf

Spinal Cord Outcomes Partnership Endeavor (SCOPE, ... Implantation of microelectrode Cortical. Recording and Stimulating (CRS) arrays in the motor cortex and sensory cortex of the brain for neural activity ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3586932/

Microelectrode arrays in combination with in vitro models of ... Microelectrode arrays (MEAs) represent an important tool to study the basic characteristics of spinal networks that control locomotion in physiological ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9954796/

Utah Array Characterization and Histological Analysis of a ... The Utah array is widely used in both clinical studies and neuroscience. It has a strong track record of safety. However, it is also known that implanted ...

7. researchgate.net researchgate.net/figure/A-Conventional-microelectrode-arrays-including-Michigan-and-Utah-probes-B_fig1_331489604

(A) Conventional microelectrode arrays including ... Spinal cord injury (SCI) results from various causes, including sports‐related incidents, degenerative cervical myelopathy, traffic accidents, and falls.