Visuomotor Prosthetic for Paralysis

Recruiting at 2 trial locations

Overseen By Emily Rosario, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Richard A. Andersen, PhD

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Intellectual impairment, Psychotic illness, Cancer, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for people with severe paralysis to communicate by using their brain signals to control a computer. The treatment involves a "brain-chip" called a Visuomotor Prosthetic, which could help users manage tasks on a tablet, such as making phone calls or watching movies, using only their thoughts. This advancement could significantly enhance daily life for those unable to move their bodies. Individuals with paralysis who can communicate verbally 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 communication for those with severe paralysis.

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 chronic oral or intravenous steroids or immunosuppressive therapy, you may not be eligible to participate.

What prior data suggests that this neural communication system is safe for human use?

Research has shown that brain-computer interfaces (BCIs), like the one used in this study, are generally safe. The BrainGate feasibility study found that these systems usually have a low rate of serious problems, indicating few major safety issues.

The BrainGate system, similar to the one used in this trial, involves placing a small device in the brain to help people control computers with their thoughts. Studies have found that these systems can operate safely for extended periods, although performance may decline over several years.

Overall, these BCIs offer many potential benefits, such as increasing independence for people with severe disabilities, with a reassuring safety record based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Visuomotor Prosthetic for paralysis is unique because it enables people to control devices with their thoughts, bypassing damaged nerves. Unlike current treatments like physical therapy or assistive devices, which rely on existing muscle function, this prosthetic uses a Neural Communication System with arrays implanted in the brain. These arrays tap into brain regions responsible for planning and executing movements, allowing users to interact with technology directly. Researchers are excited because this could revolutionize independence for individuals with paralysis, offering a way to restore control that was previously lost.

What evidence suggests that the Visuomotor Prosthetic is effective for paralysis?

Research shows that brain-computer interfaces (BCIs), such as the Visuomotor Prosthetic studied in this trial, can help people who are paralyzed communicate by using their thoughts to control devices. Studies have demonstrated that these systems enable users to make phone calls or use a computer, enhancing their independence and quality of life. The prosthetic employs a "brain-chip" to read brain signals and convert them into commands for a computer or tablet. Previous patients demonstrated control over digital environments, suggesting this technology can help restore some abilities lost due to paralysis. This method has yielded promising results in improving communication and movement skills in those with severe paralysis. ^{1 4 6 7 8}

Who Is on the Research Team?

Ausaf Bari, MD, PhD

Principal Investigator

University of California, Los Angeles

Emily Rosario, PhD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Richard A Andersen, PhD

Principal Investigator

California Institute of Technology

Are You a Good Fit for This Trial?

This trial is for individuals aged 22-65 with paralysis, able to give consent and follow instructions, who live close to the study site. They must have a caregiver, a support system, stable ventilator status, and be expected to live more than a year. Excluded are those with HIV/AIDS, active cancer, certain brain injuries or conditions preventing surgery or MRI scans.

Inclusion Criteria

I have someone to help me watch my surgery area.

Stable ventilator status

I am paralyzed due to a medical condition.

Exclusion Criteria

I have an intellectual disability.

I do not have untreated major depression or chronic psychiatric disorders.

You have a shunt for treating hydrocephalus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation and Recovery

Implantation of Neuroport Multi-Port Arrays in the posterior parietal cortex and motor cortex, followed by surgical recovery

4-6 weeks

1 surgical visit, multiple recovery visits

Training and Use

Participants learn to use thought to control a simple computer environment or a tablet computer

53-313 weeks

3-5 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 years

What Are the Treatments Tested in This Trial?

Interventions

• Visuomotor Prosthetic

Trial Overview

The trial tests a 'brain-chip' that lets severely paralyzed people control computers directly with their brain activity. Participants will learn to use this neural communication system over at least one year (up to six) to operate tablet computers for various tasks like making calls or controlling smart devices.

How Is the Trial Designed?

Group I: Neural Communication System Experimental Treatment 1 Intervention

The Neural Communication System consists of two Neuroport Multi-Port Arrays, which are descried in detail in the intervention description. One Neuroport Multi-Port Array is inserted into the posterior parietal cortex, an area of the brain used in reach planning. The second Neuroport Multi-Port Array is inserted into the motor cortex, which is primarily responsible for controlling movement. 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 use thought to control a simple computer environment or a tablet computer.

Who Is Running the Clinical Trial?

Richard A. Andersen, PhD

Lead Sponsor

Trials

3

Recruited

8+

Casa Colina Hospital and Centers for Healthcare

Collaborator

Trials

11

Recruited

350+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

The study identifies six core risk domains associated with implantable brain-computer interfaces (BCIs), including safety, cognitive impairment, and privacy concerns, which are crucial for informed consent in clinical applications.

Additionally, the research highlights three further risk domains—identity, agency, and stigma—that are often overlooked in consent processes, emphasizing the need for comprehensive discussions about the implications of BCI technology with potential participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning. Klein, E.[2018]

A 27-year-old man with tetraplegia showed significant improvements in upper limb function and coordinated grasping abilities after using a brain-computer interface (BCI) integrated with functional electrical stimulation (FES) over a period of 1,341 days.

The participant was able to transfer skills learned with the BCI-FES to novel objects and daily activities, indicating that this technology could enhance independence in daily living tasks for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Significant Gains in Skillful Grasp Coordination by an Individual With Tetraplegia Using an Implanted Brain-Computer Interface With Forearm Transcutaneous Muscle Stimulation. Bockbrader, M., Annetta, N., Friedenberg, D., et al.[2020]

The BrainGate feasibility study, involving 14 adults with quadriparesis, demonstrated that the implanted microelectrode arrays had a low rate of serious adverse events (SAEs) over an average implantation duration of 872 days, with no device-related deaths or permanent disabilities.

The most common adverse event was skin irritation, and overall, the safety profile of the BrainGate Neural Interface system is comparable to other chronically implanted medical devices, suggesting a favorable risk/benefit ratio for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. Rubin, DB., Ajiboye, AB., Barefoot, L., et al.[2023]

A novel thought-based row-column scanning communication board was developed for individuals with cerebral palsy (CP), incorporating features like automatic artifact reduction to improve EEG signal reliability.

In a study with 14 users with CP, 7 out of 11 participants were able to communicate effectively using the system, demonstrating its potential as a practical assistive device despite challenges with EEG signal quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thought-based row-column scanning communication board for individuals with cerebral palsy. Scherer, R., Billinger, M., Wagner, J., et al.[2019]

This study introduces a novel method for controlling prosthetic devices using augmented reality (AR) glasses, which track a marker on the prosthesis, offering a more intuitive and natural control mechanism compared to traditional EMG or EEG systems.

The proof-of-concept study demonstrates that this visual control system can effectively manage both a motorized hand orthosis and a motorized hand prosthesis, potentially reducing the need for extensive calibration and learning phases for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrode-free visual prosthesis/exoskeleton control using augmented reality glasses in a first proof-of-technical-concept study. Hazubski, S., Hoppe, H., Otte, A.[2021]

Brain-machine interfaces (BMIs) allow the brain to integrate neuroprosthetics as extensions of the body, creating a shared cognitive space that enhances user interaction with the environment.

Recent advancements in co-adaptive designs using reinforcement learning enable neuroprosthetics to actively assist users in achieving their goals, particularly benefiting individuals with disabilities by improving their task performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploiting co-adaptation for the design of symbiotic neuroprosthetic assistants. Sanchez, JC., Mahmoudi, B., DiGiovanna, J., et al.[2019]

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]

Neuroprostheses, which include devices that stimulate muscles and replace limbs, are advancing due to better understanding of brain physiology and improved technology, offering new therapeutic options for rehabilitation.

These innovations particularly benefit individuals with paralysis, communication disorders, and amputations, enhancing their ability to engage in social, educational, and professional activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprostheses for increasing disabled patients' mobility and control. Mikołajewska, E., Mikołajewski, D.[2012]

The study demonstrates the successful use of human cortical control signals to operate assistive technology tools, specifically a virtual keyboard speller and a computer-simulated digit, using local field potentials recorded from implanted neurotrophic electrodes.

Two subjects showed progress in effectively using these neuro-prosthetic devices, highlighting the potential for wireless transmission of cortical signals to enhance assistive technology for individuals with motor impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer control using human intracortical local field potentials. Kennedy, PR., Kirby, MT., Moore, MM., et al.[2019]

A new virtual upper limb prosthesis has been developed that mimics the full range of movements of a human arm and hand, using 27 independent dimensions, and can be controlled in real-time through both kinematic and neural inputs.

This innovative system has been successfully tested with non-human primates, demonstrating its potential as a customizable training platform for rehabilitation and the acquisition of neural prosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A training platform for many-dimensional prosthetic devices using a virtual reality environment. Putrino, D., Wong, YT., Weiss, A., et al.[2023]

Informed consent in brain-computer interface (BCI) research is particularly challenging due to rapid advancements in neuroscience and the deep connection between brain function and personal identity.

Identifying safety and research-related risks, such as cognitive impairments and privacy concerns, is crucial for developing effective informed consent protocols, which should be guided by multidisciplinary and transparent best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices. Klein, E., Ojemann, J.[2017]

Recent advancements in brain-machine interfaces, particularly cortical motor prosthetics, are expanding the potential for assisting paralyzed patients by utilizing neural signals from areas outside the traditional motor cortex.

Innovations such as local field potentials, somatosensory feedback, and improved decoding methods are enhancing the functionality and user-friendliness of these neuroprosthetic devices, making them more effective for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward more versatile and intuitive cortical brain-machine interfaces. Andersen, RA., Kellis, S., Klaes, C., et al.[2023]

This study introduces a novel brain-machine interface (BMI) paradigm that decodes cognitive brain signals related to error evaluation, allowing users to control neuroprostheses without needing to learn specific motor commands.

After a brief training period, this teaching BMI successfully operated three different neuroprostheses and adapted to various tasks, suggesting it can enhance the functionality and complexity of neuroprosthetic devices by utilizing natural brain monitoring processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching brain-machine interfaces as an alternative paradigm to neuroprosthetics control. Iturrate, I., Chavarriaga, R., Montesano, L., et al.[2018]

A virtual avatar of a macaque upper limb was developed, capable of independent movement across 27 degrees-of-freedom, allowing for advanced testing of Brain Machine Interface (BMI) decoding algorithms.

This innovative system enables real-time, closed-loop control of the virtual prosthetic, providing a cost-effective and efficient method to evaluate complex BMI technologies without needing to create physical prosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a closed-loop feedback system for real-time control of a high-dimensional Brain Machine Interface. Putrino, D., Wong, YT., Vigeral, M., et al.[2021]

A novel methodology for implanting a bi-directional cortical interface in an upper-limb amputee demonstrated the ability to control a virtual hand prosthesis using brain activity related to motor imagery, requiring only three training sessions for reliable control.

The study found that both event-related brain activity and cortical stimulation showed overlapping representations of the phantom hand, suggesting that epidural implants could provide a safe and effective communication pathway between the brain and prosthetic devices, enhancing control and functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural electrocorticography of phantom hand movement following long-term upper-limb amputation. Gharabaghi, A., Naros, G., Walter, A., et al.[2021]

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This paper will review what is currently being done with prosthetics implementing BMI technology, focusing on the integration of proprioceptive and ...

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sciencedirect.com

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Through the integration of BCI and FES technologies, a novel artificial neural rehabilitation system demonstrated significantly greater improvements in motor ...

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iopscience.iop.org

iopscience.iop.org/article/10.1088/1741-2560/13/2/023001/pdf

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Specifically, moving BCI devices from the laboratory to US patients could potentially be impeded by gaps in scientific and clinical knowledge, questions.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12026362/

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The system achieved a median character error rate of 6.13% and a median word error rate of 10.53% during the copy-typing task. The median ...

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neurology.org

neurology.org/doi/10.1212/WNL.0000000000201707

Interim Safety Profile From the Feasibility Study of ...

This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs.

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iopscience.iop.org

iopscience.iop.org/article/10.1088/1741-2552/adc48c/pdf

5-year follow-up of a fully implanted brain–computer ...

Invasive intracortical BCIs have shown promise in clinical trials but degrade in the chronic period and tether patients to acquisition hardware.