Spinal Cord Injury, Tetraplegia
Conditions
Keywords
Tetraplegia, Spinal cord injury, Brainstem or spinal stroke, Neuroprosthetic, Brain-machine interface, Brain-computer interface, Neural activity
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.
Interventions
DEVICEImplantation of NeuroPort Arrays in the motor cortex
Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
Sponsors
Michael Boninger
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brain-Machine Interface Users All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group.
Implantation of NeuroPort Arrays in the motor cortex: Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Brain-Machine Interface Users |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Participants With Successful Implant
Number of participants who were implanted for at least one year without having to explant the device for safety reasons.
Time frame: One year following array implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brain-Machine Interface Users | Number of Participants With Successful Implant | 1 Participants |
Secondary
10 Degree-of-freedom Movement by Neural Control
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.
Time frame: One year following array implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brain-Machine Interface Users | 10 Degree-of-freedom Movement by Neural Control | 15.6 score on a scale |
Secondary
7 Degree-of-freedom Movement by Neural Control
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.
Time frame: One year following array implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brain-Machine Interface Users | 7 Degree-of-freedom Movement by Neural Control | 16 score on a scale |