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

Trial Summary

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 data supports the idea that Brain-Machine Interface for Quadriplegia is an effective treatment?

The available research shows that the Brain-Machine Interface for Quadriplegia is effective in improving hand and arm functions for people with spinal cord injuries. One study found that individuals using an advanced neuroprosthesis experienced improvements in grasp strength, range of motion, and independence in daily activities. Another study demonstrated that a computerized neuromuscular stimulation system allowed patients to perform tasks like writing, eating, and drinking. These results suggest that this treatment can significantly enhance the quality of life for individuals with quadriplegia. ^{1 2 3 4 5}

What safety data exists for the Brain-Machine Interface for Quadriplegia?

The safety data for the Brain-Machine Interface for Quadriplegia, which may be evaluated under names like Neural Prosthetic System 2 (NPS2) or Neuroport Array, is not explicitly detailed in the provided research. However, the studies discuss the challenges and improvements in neural interface systems, such as microelectrode arrays (MEAs), which are crucial components of these systems. Strategies to improve biocompatibility and reduce foreign body response (FBR) are highlighted, indicating ongoing efforts to enhance safety. The development of modular neuroprosthetic systems like the Networked Neuroprosthesis (NNP) shows successful testing in individuals with spinal cord injury, suggesting a focus on safety and functionality. Additionally, the importance of patient-centered benefit-risk assessment and regulatory processes is emphasized, indicating a structured approach to ensuring safety in neuroprosthetic development. ^{5 6 7 8 9}

Is the treatment Neural Prosthetic System 2 (NPS2) a promising treatment for quadriplegia?

Yes, the Neural Prosthetic System 2 (NPS2) is a promising treatment for quadriplegia. It uses advanced technology to connect the brain to machines, helping restore movement and function. The system is designed to be highly efficient and can handle a lot of information, which is important for helping people with severe paralysis. ^{10 11 12 13 14}

What is the purpose of this trial?

This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sensory feedback. Development of a brain-machine interface is very difficult and currently only limited technology exists in this area of neuroscience. Other studies have shown that people with high spinal cord injury still have intact brain areas capable of planning movements and grasps, but are not able to execute the movement plans. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information and sense feeling in the hand and fingers. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb. A key part of this study is to electrically stimulate the brain by introducing a small amount of electrical current into the electrodes in the sensory area of the brain. This will result in the sensation of touch in the hand and/or fingers. This stimulation to the brain will occur when the robotic limb touches the object, thereby allowing the brain to "feel" what the robotic arm is touching. The device being used in this study is called the Neuroport Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists of a small grid of electrodes that will be implanted in brain tissue and a small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude through the scalp to allow for connection with the computer equipment. The top portion of the pedestal has a protective cover that will be in place when the pedestal is not in use. The top of this pedestal and its protective cover will be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted in this study so three of these protective covers will be visible outside of the head. It will be possible to cover these exposed portions of the device with a hat or scarf. The investigators hope to learn how safe and effective the Neuroport array plus stimulation is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands.

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

Eligibility Criteria

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

I am currently undergoing chemotherapy or have active cancer.

I have diabetes.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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 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]

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]

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]

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 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 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]

References

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

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

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

Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. [2007]

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

Upper limb functions regained in quadriplegia: a hybrid computerized neuromuscular stimulation system. [2006]

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

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

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

A Critical Review of Microelectrode Arrays and Strategies for Improving Neural Interfaces. [2023]

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

Neuroprosthetics and the science of patient input. [2019]

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

Technology transfer of neuroprosthetic devices. [2011]

9. Egypt pubmed.ncbi.nlm.nih.gov

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

10. Canada pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Baseplate for two-stage cranial mounting of BMI connectors. [2013]

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

Flexible polyimide-based intracortical electrode arrays with bioactive capability. [2009]

13. 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]

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

Evaluation of command sources for a high tetraplegia neural prosthesis. [2020]