Actively Recruiting

Phase Not Applicable
Age: 22Years - 65Years
All Genders
NCT01964261

Sensory Motor Transformations in Human Cortex

Led by Richard A. Andersen, PhD · Updated on 2025-05-22

5

Participants Needed

4

Research Sites

691 weeks

Total Duration

On this page

Sponsors

R

Richard A. Andersen, PhD

Lead Sponsor

U

University of Southern California

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Sensory Motor Transformations in Human Cortex

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • High cervical spinal lesion
  • Age 22-65 years
  • Able to provide informed consent
  • Able to understand and follow instructions in English
  • Able to communicate via speech
  • Cleared for surgery
  • Life expectancy greater than 12 months
  • Willing to travel up to 60 miles to study locations up to five days per week
  • Have a caregiver to monitor surgical site complications and behavioral changes daily
  • Have psychosocial support system
Not Eligible

You will not qualify if you...

  • Memory problems
  • Intellectual impairment
  • Psychotic illness or chronic psychiatric disorder, including untreated major depression
  • Poor vision
  • Pregnancy
  • Active infection or unexplained fever
  • Scalp lesions or skin breakdown
  • HIV or AIDS
  • Active cancer or undergoing chemotherapy
  • Diabetes
  • Autonomic dysreflexia
  • Seizure history
  • Implanted hydrocephalus shunt
  • Previous neurosurgery affecting parietal lobe function
  • Medical conditions contraindicating surgery or device implantation
  • Prior cranioplasty
  • Unable to have MRI or anticipate need for MRI during study
  • Nursing an infant or unwilling to bottle-feed
  • Chronic steroid or immunosuppressive therapy
  • Suicidal thoughts
  • Drug or alcohol dependence
  • Planning pregnancy or unwilling to use birth control
  • Implanted cardiac defibrillator, pacemaker, vagal nerve stimulator, or spinal cord stimulator
  • Implanted deep brain stimulator, DBS leads, or cochlear implant

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States, 90242

Actively Recruiting

2

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

3

Richard Andersen

Pasadena, California, United States, 91125

Actively Recruiting

4

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

C

Charles Liu, MD, PhD

CONTACT

R

Richard Andersen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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