Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Not Applicable

Terminated

Conditions: Spinal Cord Injury
Tetraplegia

Interventions: Device: Implantation of NeuroPort Arrays in the motor cortex

Registration Number: NCT01364480

Lead Sponsor: Michael Boninger

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brain-Machine Interface Users	Implantation of NeuroPort Arrays in the motor cortex	All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Implant	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 Outcome Measures

Name	Time	Method
7 Degree-of-freedom Movement by Neural Control	One year following array implantation	A modified Action Research Arm Test (ARAT) assessment for upper extremity performance was conducted to evaluate neural control of movement of a robotic prosthetic arm with 7 independent degrees of freedom controlled simultaneously. The degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 1D open/closing of hand. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Each test item was timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s to complete were scored as 2. The participant attempted each assessment three times and the best score was included. The total possible score ranged from 0 to 27 (i.e., max possible score of 3 each for 9 total tasks). A higher score indicates a better outcome.
10 Degree-of-freedom Movement by Neural Control	One year following array implantation	A modified ARAT was conducted to assess neural control of movement of a robotic prosthetic arm with 10 independent degrees of freedom, controlled simultaneously. Degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 4 degrees dictating hand shape, including pinch (flexion of thumb, index and middle fingers), scoop (flexion of ring and pinky fingers), finger abduction (of index, ring and little fingers), and thumb opposition. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Test items were timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s to complete were scored as 2. The participant attempted each assessment three times and the best score was included. The total possible score ranged from 0 to 27 (i.e., max possible score of 3 each for 9 total tasks). A higher score indicates a better outcome.