Clinical Trial: Cortical Recording and Stimulating Array Brain-Machine Interface

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Brief Summary: The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and microstimulation of brain sensory cortex.

Detailed Summary: Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of the use of the arms and legs) have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural (nerve) signals are generated even though they do not reach the arms, hands and legs. By placing (implanting) sensors on the surface of the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays. Using neural activity to control an external device is referred to as a brain-machine interface (BMI) technology. In addition, areas of the brain that are involved in interpreting sensations from the arms, hands and legs remain functional after injury. It is therefore possible to send tiny electrical pulses through implanted arrays to mimic sensory input that would normally come from the arms, hands and legs. The investigators refer to this as "microstimulation."
Sponsor: University of Pittsburgh

Current Primary Outcome: The primary outcome is the safety of the participant. [ Time Frame: One year following array implantation ]

This measure will be considered a success if the device is not removed for safety reasons during the 12-month post-implant evaluation.


Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices. [ Time Frame: One year following array implantation ]

The efficacy of the CRS Arrays will be determined through a variety of measures, including characterization of signal quality, degrees of freedom achieved and subject performance.


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: July 3, 2013
Date Started: December 2013
Date Completion: December 2018
Last Updated: February 13, 2017
Last Verified: February 2017