Visuomotor Prosthetic for Paralysis

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

Interventions

DEVICE

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.

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• Casa Colina Hospital and Centers for Healthcare

  collaborator OTHER

• Richard A. Andersen, PhD

  lead OTHER

Principal Investigators

• Richard A Andersen, PhD · California Institute of Technology

• Ausaf Bari, MD, PhD · University of California, Los Angeles

• Emily Rosario, PhD · Casa Colina Hospital and Centers for Healthcare

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

22 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-01

Primary Completion

2031-04-30

Completion

2031-07-31

Countries

• United States

Study Locations