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

Trial Summary

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 data supports the effectiveness of the treatment Visuomotor Prosthetic for Paralysis?

Research shows that brain-computer interfaces (BCIs) and neuroprosthetics can help people with paralysis regain some control over their movements. For example, individuals with tetraplegia (paralysis of all four limbs) have shown improved grasp coordination using BCIs, and virtual reality environments have been used to train users in controlling prosthetic devices effectively. ^{1 2 3 4 5}

What safety data exists for the Visuomotor Prosthetic (Brain-Computer Interface) in humans?

The BrainGate feasibility study, the largest and longest-running clinical trial of an implanted brain-computer interface (BCI), provides safety data for these devices in humans. It highlights the importance of identifying risks such as short and long-term safety, cognitive and communicative impairment, and privacy concerns, which are crucial for informed consent in BCI research. ^{6 7 8 9 10}

How is the Visuomotor Prosthetic treatment different from other treatments for paralysis?

The Visuomotor Prosthetic is unique because it uses a brain-computer interface (a system that connects the brain to a computer) to control a virtual or physical prosthetic device in real-time, allowing for more natural and intuitive movement. Unlike traditional methods that rely on muscle signals, this treatment can provide more precise control by directly interpreting brain signals, potentially offering greater functionality for individuals with paralysis. ^{11 12 13 14 15}

What is the purpose of this trial?

The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prospective, longitudinal, single-arm early feasibility study will be used to examine the safety and effectiveness of using a neural communication system to control a simple computer interface and a tablet computer. Initial brain control training will occur in simplified computer environments, however, the ultimate objective of the clinical trial is to allow the human patient autonomous control over the Google Android tablet operating system. Tablet computers offer a balance of ease of use and functionality that should facilitate fusion with the BMI. The tablet interface could potentially allow the patient population to make a phone call, manage personal finances, watch movies, paint pictures, play videogames, program applications, and interact with a variety of "smart" devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic limbs and smart cars. Brain control of tablet computers has the potential to greatly improve the quality of life of severely paralyzed individuals. Five subjects will be enrolled, each implanted with the NCS for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Neuroprostheses for increasing disabled patients' mobility and control. [2012]

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

Exploiting co-adaptation for the design of symbiotic neuroprosthetic assistants. [2019]

3. United States 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. [2020]

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

Computer control using human intracortical local field potentials. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A training platform for many-dimensional prosthetic devices using a virtual reality environment. [2023]

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

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

Thought-based row-column scanning communication board for individuals with cerebral palsy. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Teaching brain-machine interfaces as an alternative paradigm to neuroprosthetics control. [2018]

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

Development of a closed-loop feedback system for real-time control of a high-dimensional Brain Machine Interface. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Electrode-free visual prosthesis/exoskeleton control using augmented reality glasses in a first proof-of-technical-concept study. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Epidural electrocorticography of phantom hand movement following long-term upper-limb amputation. [2021]

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

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

15. England pubmed.ncbi.nlm.nih.gov

Toward more versatile and intuitive cortical brain-machine interfaces. [2023]