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.

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NCT01958086

Visuomotor Prosthetic for Paralysis

Recruiting
NAAges 22–65InterventionalBasic science
Richard A. Andersen, PhD
~2 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Neural Communication System

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subject control of a tablet computer
Measured over Six years after array implantation
+1 more outcome measured
Quadriplegia
3 sites across 1 states
California3
  • 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

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Eligibility criteria

Inclusion

Pathology resulting in paralysis
Age 22-65 years
Able to provide informed consent
Understand and comply with instructions, if necessary, with the aid of a translator
Able to communicate via speech
Surgical clearance
Life expectancy greater than 12 months
Live within 60 miles of study location and willing to travel up to 5 days per week
A regular caregiver to monitor the surgical site
Psychosocial support system
Stable ventilator status

Exclusion

Intellectual impairment
Psychotic illness or chronic psychiatric disorder, including major depression if untreated
Poor visual acuity
Pregnancy
Active infection or unexplained fever
Scalp lesions or skin breakdown
HIV or AIDS infection
Active cancer or chemotherapy
Medically uncontrolled diabetes
Autonomic dysreflexia
History of seizure
Implanted hydrocephalus shunt
History of supratentorial brain injury or neurosurgery
Medical conditions contraindicating surgery and chronic implantation of a medical device
Unable to undergo MRI or anticipated need for MRI during study
Nursing an infant or unwilling to bottle-feed infant
Chronic oral or intravenous use of steroids or immunosuppressive therapy
Suicidal ideation
Drug or alcohol dependence
Planning to become pregnant, or unwilling to use adequate birth control
Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.
  • 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