Brain-Machine Interface for Quadriplegia

Recruiting at 4 trial locations

Overseen By Richard Andersen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Richard A. Andersen, PhD

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: Memory problems, Psychotic illness, Diabetes, 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: 6

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a brain-controlled medical device, the Neural Prosthetic System 2 (NPS2), to help individuals with high spinal cord injuries regain control over external devices, such as a computer cursor or robotic limb, using their thoughts. The device uses tiny electrodes implanted in the brain to capture movement plans and provide a sense of touch through electrical stimulation. The researchers seek to test the safety and effectiveness of this approach. Individuals with a high spinal cord injury who can travel up to 60 miles to the study location might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform lives.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic oral or intravenous steroids or immunosuppressive therapy, you may not be eligible to participate.

What prior data suggests that this brain-machine interface is safe for people with quadriplegia?

Research has shown that the Neuroport Array, used in the Neural Prosthetic System 2, has undergone testing in other studies. In these studies, researchers placed the device in the brain for long-term monitoring. The BrainGate trial, which used similar technology, collected safety data over more than 12,000 participant-days, meaning the device was used for over 17,000 days in total.

Safety results from these trials indicate that the Neuroport Array has generally been well-tolerated in the brain, with no major safety issues reported. This suggests the technology might be safe, although it remains experimental as the FDA has not approved it for general use.

Overall, while researchers continue to study this technology, existing data suggests a promising safety profile for potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Neural Prosthetic System 2 (NPS2) because it offers a groundbreaking approach for individuals with quadriplegia. Unlike traditional treatments that might rely on assistive devices or therapies to improve limited mobility, NPS2 directly interfaces with the brain. It uses three Neuroport Arrays inserted into specific brain areas to facilitate control over an end effector by thought, enhanced with sensory feedback through intracortical microstimulation. This innovative method not only aims to restore movement but also to provide sensation, potentially transforming the quality of life for those affected by severe paralysis.

What evidence suggests that the Neuroport Array is effective for quadriplegia?

Research has shown that the Neural Prosthetic System 2, utilizing the Neuroport Array, might help individuals with spinal cord injuries regain some movement control. Participants in this trial will use this system, which studies have found connects brain activity to devices like computer cursors and robotic limbs. This capability could assist people with paralysis by translating their thoughts into actions. The system also uses electrical signals in the brain to recreate a sense of touch, potentially making the use of the robotic limb feel more natural. Although still experimental, this approach holds promise for increasing independence in those with quadriplegia. ^{5 6 7 8 9}

Who Is on the Research Team?

Luke Bashford, PhD

Principal Investigator

University of Colorado, Denver

Dan Kramer, MD

Principal Investigator

University of Colorado, Denver

Richard A Andersen, PhD

Principal Investigator

California Institute of Technology

Charles Liu, MD, PhD

Principal Investigator

University of Southern California, Rancho Los Amigos Rehabilitation Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 22-65 with high spinal cord injuries resulting in quadriplegia, who can communicate in English and follow instructions. They must have a support system, be able to travel to the study site frequently, and have someone to monitor them daily post-surgery. Exclusions include memory or psychiatric disorders, poor vision, certain infections or cancers, diabetes, seizures history, MRI contraindications among others.

Inclusion Criteria

I am between 22 and 65 years old.

My caregiver checks me daily for surgery complications and changes in my behavior.

I can travel up to 60 miles for the study 5 days a week.

Exclusion Criteria

Pregnancy

You have a shunt for hydrocephalus.

I am currently undergoing chemotherapy or have active cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Surgical procedure to implant the Neuroport Arrays and attach the percutaneous pedestal to the skull

1 week

Recovery and Initial Training

Participants recover from surgery and begin initial training to control the end effector using thought and sensory feedback

4-6 weeks

3-5 sessions per week

Ongoing Training and Evaluation

Participants engage in study sessions to control an end effector and perform reach and grasp tasks, with ongoing evaluation of control accuracy and safety

9 years

3-5 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after the main training and evaluation phase

9 years

What Are the Treatments Tested in This Trial?

Interventions

• Neural Prosthetic System 2 (NPS2)

Trial Overview The trial tests a brain-machine interface called Neural Prosthetic System 2 (NPS2), which involves implanting electrodes into the brain to allow control of devices like robotic limbs using thoughts and sensory feedback. The safety and effectiveness of this experimental device will be evaluated.

How Is the Trial Designed?

Group I: Neural Prosthetic System 2 Experimental Treatment 1 Intervention

The Neural Prosthetic System 2 consists of three Neuroport Arrays, which are described in detail in the intervention description. Two of the three Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The third Neuroport Array is inserted into somatosensory cortex, specifically S1 which represents sensory feedback for the hand and fingers. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought augmented with sensory feedback via intracortical microstimulation. They will then use the end effector to perform various reach and grasp tasks.

Neural Prosthetic System 2 (NPS2) is already approved in United States for the following indications:

Approved in United States as Neural Prosthetic System 2 for:

• Experimental use in clinical trials for spinal cord injury patients

Who Is Running the Clinical Trial?

Richard A. Andersen, PhD

Lead Sponsor

Trials

3

Recruited

8+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Rancho Los Amigos National Rehabilitation Center

Collaborator

Trials

10

Recruited

2,000+

University of Colorado - Anschutz Medical Campus

Collaborator

Trials

9

Recruited

1,700+

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]

A computerized neuromuscular stimulation system successfully enabled two patients with complete quadriplegia to perform tasks like writing, eating, and drinking by integrating their residual shoulder movements with stimulated muscle activity.

The system allowed patients to control movements through simple vocal commands, demonstrating a significant advancement in assistive technology for individuals with severe mobility impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper limb functions regained in quadriplegia: a hybrid computerized neuromuscular stimulation system. Nathan, RH., Ohry, A.[2006]

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 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]

The study presents a new multichannel neural interface made from flexible polyimide, which is designed to improve the quality of life for individuals who are deaf, blind, or paralyzed, by providing a safe and effective connection to the central nervous system.

In vivo and in vitro tests indicate that this polyimide-based device has favorable biological, electrical, and mechanical properties, making it a promising candidate for long-term neural implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible polyimide-based intracortical electrode arrays with bioactive capability. Rousche, PJ., Pellinen, DS., Pivin, DP., et al.[2009]

The implanted neuroprosthesis significantly improved grasp and release abilities in 49 out of 50 tetraplegic participants, enhancing their independence in daily activities.

Over 90% of participants reported regular home use of the device and high satisfaction, indicating that the neuroprosthesis is safe, well-accepted, and provides substantial functional benefits for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. Peckham, PH., Keith, MW., Kilgore, KL., et al.[2007]

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]

Neuralink has developed a high-bandwidth brain-machine interface with up to 3072 electrodes per array, significantly increasing the potential for restoring sensory and motor functions compared to existing systems.

The system includes a neurosurgical robot that can insert electrodes with micron precision, achieving a spiking yield of up to 70% in chronically implanted electrodes, which enhances the reliability and effectiveness of the interface.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Brain-Machine Interface Platform With Thousands of Channels. Musk, E.[2022]

Microelectrode arrays (MEAs) in neural interface systems (NISs) can be improved for better clinical use by enhancing their biocompatibility through various strategies, such as surface modifications and flexible designs.

Techniques like using hydrogels, altering surface topography, and optimizing MEA geometries can significantly reduce the foreign body response and improve the longevity and performance of MEAs when implanted in brain tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Critical Review of Microelectrode Arrays and Strategies for Improving Neural Interfaces. Ferguson, M., Sharma, D., Ross, D., et al.[2023]

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]

The number of neuroprosthetic devices in clinical use is increasing, with around 3,000 systems currently available, indicating a growing acceptance and integration of these technologies in healthcare.

Successful development and regulatory approval of neuroprosthetic devices require understanding the needs and preferences of all stakeholders, including end-users, to enhance device design and ensure effective rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology transfer of neuroprosthetic devices. Peckham, PH., Thrope, G., Woloszko, J., et al.[2011]

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 study evaluated three command interfaces for controlling a robotic arm in individuals with high tetraplegia, focusing on head orientation and EMG signals from facial muscles.

The EMG interface showed a slightly higher information transfer rate (0.55 Bits/sec) compared to head orientation interfaces (0.49 Bits/sec), suggesting that EMG may be a more effective command source for neural prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of command sources for a high tetraplegia neural prosthesis. Williams, M., Kirsch, R.[2020]

The review highlights the evolution of implantable electrical interfaces with the nervous system, emphasizing the need for a systematic approach to product development that incorporates scientific understanding, technology availability, and regulatory pathways.

Despite some successes in neural prosthetics, the field faces challenges with dubious claims and the necessity for rigorous assessment to ensure safety and efficacy in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Prosthetics:A Review of Empirical vs. Systems Engineering Strategies. Loeb, GE.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01849822

Study Details | NCT01849822 | Providing Brain Control of ... The Neural Prosthetic System consists of two Neuroport Arrays, which are described in detail in the intervention description. Both Neuroport Arrays are inserted ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4805425/

Clinical translation of a high performance neural prosthesis Neural prostheses have the potential to improve the quality of life of individuals with paralysis by directly mapping neural activity to limb and computer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01364480

Microelectrode Brain-Machine Interface for Individuals With ... The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8637800/

Implantable brain–computer interface for neuroprosthetic ... In this study, we sought to evaluate the safety, efficacy and long-term stability of a fully implanted BCI for control of a volitional hand grasp in a subject ...

5. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(24)00222-X/fulltext

Clinical trials for implantable neural prostheses We outline patient-centred research ethics requirements for clinical trials involving implantable neural prostheses.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01364480?term=blackrock&draw=2&rank=9

Microelectrode Brain-Machine Interface for Individuals With ... The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10074470/

Interim Safety Profile From the Feasibility Study of the ... The BrainGate trial has accrued more than 12,000 participant-days of safety data, with more than 17,000 array-days (some participants received 2 arrays ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00912041

BrainGate2: Feasibility Study of an Intracortical Neural ... The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. One year post-implant evaluation period. Secondary ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S258975002400222X

Viewpoint Clinical trials for implantable neural prostheses This new phase raises the question of how clinical trials should be designed to scientifically and ethically address the unique features of neural prostheses.