Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Number of Participants With Successful Implant
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Limited or no ability to use both hands due to cervical spinal cord injury or brainstem or spinal stroke
- •At least 1 year post-injury
- •Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training
- •Additional inclusion criteria must also be reviewed
Exclusion Criteria
- •Certain implanted devices
- •Presence of other serious disease or disorder that could affect ability to participate in this study
- •Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise
- •Additional exclusion criteria must also be reviewed
Outcomes
Primary Outcomes
Number of Participants With Successful Implant
Time Frame: One year following array implantation
Number of participants who were implanted for at least one year without having to explant the device for safety reasons.
Secondary Outcomes
- 7 Degree-of-freedom Movement by Neural Control(One year following array implantation)
- 10 Degree-of-freedom Movement by Neural Control(One year following array implantation)
Investigators
Michael Boninger
Vice Chair of Research
University of Pittsburgh