Visuomotor Prosthetic for Paralysis
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation and Recovery
Implantation of Neuroport Multi-Port Arrays in the posterior parietal cortex and motor cortex, followed by surgical recovery
Training and Use
Participants learn to use thought to control a simple computer environment or a tablet computer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Visuomotor Prosthetic
Find a Clinic Near You
Who Is Running the Clinical Trial?
Richard A. Andersen, PhD
Lead Sponsor
Casa Colina Hospital and Centers for Healthcare
Collaborator
University of California, Los Angeles
Collaborator