2 Participants Needed

Visuomotor Prosthetic for Paralysis

Recruiting at 2 trial locations
AB
ER
Overseen ByEmily Rosario, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.1112131415

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

AB

Ausaf Bari, MD, PhD

Principal Investigator

University of California, Los Angeles

ER

Emily Rosario, PhD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

RA

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.
See 8 more

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.
See 18 more

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
1Treatment groups
Experimental Treatment
Group I: Neural Communication SystemExperimental Treatment1 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.

Find a Clinic Near You

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.
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.
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.
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]

References

Neuroprostheses for increasing disabled patients' mobility and control. [2012]
Exploiting co-adaptation for the design of symbiotic neuroprosthetic assistants. [2019]
Clinically Significant Gains in Skillful Grasp Coordination by an Individual With Tetraplegia Using an Implanted Brain-Computer Interface With Forearm Transcutaneous Muscle Stimulation. [2020]
Computer control using human intracortical local field potentials. [2019]
A training platform for many-dimensional prosthetic devices using a virtual reality environment. [2023]
Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. [2023]
Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning. [2018]
Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices. [2017]
Thought-based row-column scanning communication board for individuals with cerebral palsy. [2019]
Teaching brain-machine interfaces as an alternative paradigm to neuroprosthetics control. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Development of a closed-loop feedback system for real-time control of a high-dimensional Brain Machine Interface. [2021]
Electrode-free visual prosthesis/exoskeleton control using augmented reality glasses in a first proof-of-technical-concept study. [2021]
Epidural electrocorticography of phantom hand movement following long-term upper-limb amputation. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
A novel command signal for motor neuroprosthetic control. [2021]
Toward more versatile and intuitive cortical brain-machine interfaces. [2023]
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