Visuomotor Prosthetic for Paralysis
This study is testing a new device called the Neural Communication System, which involves implanting "brain-chips" (NeuroPort Arrays) into the brain's motor cortex. The goal is to help people with quadriplegia (paralysis affecting all four limbs) control a computer or tablet directly with their thoughts. Researchers want to see if this system is safe and effective in allowing you to control a simple computer interface and eventually a Google Android tablet. Success would mean you can control a tablet computer and that there are no infections or irritation from the device, both measured up to six years after the implant. This study is for people aged 22 to 65 who have paralysis, can communicate, and live within 60 miles of the study location.
- Study design
- This is an early feasibility study with a single group of participants. It plans to enroll 2 people.
- What's involved
- You would need to live within 60 miles of the study location and be willing to travel up to 5 days per week. The study involves surgical implantation of the NeuroPort Arrays.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for six years after the array implantation to check for tablet control and absence of infection or irritation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Visuomotor Prosthetic for Paralysis
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- Richard A Andersen, PhD · PRINCIPAL_INVESTIGATOR · California Institute of Technology
- Ausaf Bari, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
- Emily Rosario, PhD · PRINCIPAL_INVESTIGATOR · Casa Colina Hospital and Centers for Healthcare
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Subject control of a tablet computerSix years after array implantation
Assessments will be compared with chance and previous reports of BMI efficacy using control signals derived from primary motor cortex. Computer-interface competency examination that measures the ability of the subject to control various aspects of the tablet user interface. Additionally we will measure the Quality of Life Inventory (QOLI) at regular intervals over the duration of the study. Changes in performance over time.
- Absence of infection or irritationSix years after array implantation
The Serious Adverse event (SAE) rate will be calculated as the number of SAEs per implant-days. The SAE rate will be continuously compared to the 1% threshold level. CT scan; inspection of patient's scalp for evidence of reddening or discharge; review of new symptoms including possible fever, headache, visual or auditory changes, or change in mood or behavior; serial neurologic exams. The condition of the area will be compared with its condition on previous visits. History will be obtained regarding new symptoms. Neurologic exam will be compared to baseline neurologic exam