Recruiting

Visuomotor Prosthetic

Sponsor:

Richard A. Andersen, PhD

Code:

NCT01958086

Conditions

Quadriplegia

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Neural Communication System

Study Details

Brief summary:

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.

Conditions

Quadriplegia

Study ID

NCT01958086

Start date

Oct 1, 2013

Status verified date

Mar, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Apr 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

2 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Neural Communication System

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.

Interventions

Neural Communication System

NeuroPort Arrays allow for the local recording of cerebral cortex. The Neural Communication system is primarily composed of two NeuroPort Arrays. The two arrays of one MultiPort device will be placed in the primary motor cortex for recording (Platinum-tipped electrodes); and the two arrays of the additional MultiPort device be placed in the superior parietal lobule for recording (Platinum-tipped electrodes). Each MultiPort device consists of two arrays, each with 100 electrodes in a 10 x 10 configuration, with dimensions 4 mm x 4 mm x 1.5 mm (W x H x D) or 4 mm x 4 mm x 1.0 mm, and a titanium percutaneous connector, 19 mm diameter at the base. Each MultiPort can have a total of 128 active channels (capable of transmitting neural signals to the percutaneous connector) across the two arrays. In our design, we will split active channels evenly between the two arrays resulting in 64 active channels per array.

Primary outcome measure

  • Subject control of a tablet computer [ Time Frame: Six years after array implantation ]
  • Absence of infection or irritation [ Time Frame: Six years after array implantation ]

Central Contacts and Locations

Central contacts

Ausaf Bari, MD, PhD

310-825-5111ABari@mednet.ucla.edu

Emily Rosario, PhD

909.596.7733ERosario@casacolina.org

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

California Institute of Technology

Recruiting

Pasadena, California, United States, 91125

Casa Colina Centers for Rehabilitation

Recruiting

Pomona, California, United States, 91769

Contacts

Emily Rosario, PhD

909-596-7733erosario@casacolina.org

More Information

Sponsor

Richard A. Andersen, PhD

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Neural
  • Prosthetic
  • brain machine interface
  • brain computer interface
  • brain control
  • paralysis
  • tetraplegia
  • quadriplegia
  • spinal cord injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Richard A. Andersen, PhD on 2026-03-18.