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)

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.12345

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.14678

Who Is on the 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

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

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+

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

Citations

Visuomotor Prosthetic for ParalysisWhat data supports the effectiveness of the treatment Visuomotor Prosthetic for Paralysis? Research shows that brain-computer interfaces (BCIs) and ...
Review of Brain-Machine Interfaces Used in Neural ...This paper will review what is currently being done with prosthetics implementing BMI technology, focusing on the integration of proprioceptive and ...
The Recent Advances of Brain-Computer Interfaces in ...Through the integration of BCI and FES technologies, a novel artificial neural rehabilitation system demonstrated significantly greater improvements in motor ...
Brain–computer interfaces: communication and restoration of ...We focus on non-invasive brain–computer interfaces (BCIs) and their clinical utility for direct brain communication in paralysis and motor restoration in stroke ...
Brain–computer interface devices for patients with ...Specifically, moving BCI devices from the laboratory to US patients could potentially be impeded by gaps in scientific and clinical knowledge, questions.
Invasive Brain–Computer Interface for CommunicationThe 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 ...
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.
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.
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