Sensory Motor Transformations in Human Cortex

Summary

This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sensory feedback.

Development of a brain-machine interface is very difficult and currently only limited technology exists in this area of neuroscience. Other studies have shown that people with high spinal cord injury still have intact brain areas capable of planning movements and grasps, but are not able to execute the movement plans. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information and sense feeling in the hand and fingers. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb.

A key part of this study is to electrically stimulate the brain by introducing a small amount of electrical current into the electrodes in the sensory area of the brain. This will result in the sensation of touch in the hand and/or fingers. This stimulation to the brain will occur when the robotic limb touches the object, thereby allowing the brain to "feel" what the robotic arm is touching.

The device being used in this study is called the Neuroport Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists of a small grid of electrodes that will be implanted in brain tissue and a small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude through the scalp to allow for connection with the computer equipment. The top portion of the pedestal has a protective cover that will be in place when the pedestal is not in use. The top of this pedestal and its protective cover will be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted in this study so three of these protective covers will be visible outside of the head. It will be possible to cover these exposed portions of the device with a hat or scarf.

The investigators hope to learn how safe and effective the Neuroport array plus stimulation is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands.

Conditions

• Quadriplegia

Interventions

DEVICE

Neural Prosthetic System 2 (NPS2)

The NPS2 comprises 3 NeuroPort Arrays (SIROF). The tip of the electrodes are sputtered iridium oxide film (SIROF). Each array is comprised of 100 1.5 mm microelectrodes organized on a 4mm x 4mm silicon base that is 0.25 mm thick. Each microelectrode is insulated with Parylene-C polymer and is electrically isolated from neighboring electrodes by non-conducting glass. Of the 100 electrodes, 96 are wire bonded using 25m gold alloy insulated wires sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the circuit board is inserted into the Patient Pedestal (percutaneous connector), and then the Patient Pedestal is filled with silicone elastomer. Two fine platinum reference wires are also attached to the Patient Pedestal. The Patient Pedestal is 19 mm wide at the skin interface.

Sponsors & Collaborators

• University of Southern California

  collaborator OTHER

• Rancho Los Amigos National Rehabilitation Center

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Richard A. Andersen, PhD

  lead OTHER

Principal Investigators

• Richard A Andersen, PhD · California Institute of Technology

• Charles Liu, MD, PhD · University of Southern California, Rancho Los Amigos Rehabilitation Center

• Dan Kramer, MD · University of Colorado, Denver

• Luke Bashford, PhD · University of Colorado, Denver

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

2013-11-01

Primary Completion

2026-07-31

Completion

2027-01-31

FDA Device

Yes

Countries

• United States

Study Locations