The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.
Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of 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 signals are generated even though they are not sent to the arms, hands and legs. By implanting electrodes in 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.
- Implantation of NeuroPort Arrays in the motor cortex Device
Other Names: neuroprosthetic; brain-machine interface; brain-computer interface Intervention Desc: Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants. ARM 1: Kind: Experimental Label: Brain-Machine Interface Users Description: All participants enrolled in the study will be individuals implanted with microelectrodes in their brain to record neural activity. There is no control group.
- Allocation: Non-Randomized
- Masking: Open Label
- Endpoint: Safety Study
- Intervention: Single Group Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||The primary outcome is the safety of the participant.||One year following array implantation||Yes|
|Secondary||The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices.||One year following array implantation||No|