The study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG) system or using their intracranially implanted devices Electrocorticographic (ECoG).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
3
This will be a one time surgery lasting no more than 2 hours where ESCS electrodes will be connected to an external stimulator approved for human research. Stimulation intensity and parameters will be configured before each session for optimal upper extremity motor function. The ESCS approach will include surgical implantation of temporarily placed leads in the cervical epidural space and connection cables tunneled percutaneously through the skin for \<30 days
Neural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices.
Lynn Rehabilitation Center
Miami, Florida, United States
NOT_YET_RECRUITINGThe Miami Project to Cure Paralysis
Miami, Florida, United States
RECRUITINGChange in Hand Motor Function
Toronto Rehabilitation Institute Hand Function Test (TRI-HFT): Measured on a scale from 0-133 to assess upper extremity manipulation and grip force at time points before and after implant. Higher scores indicate better hand motor function.
Time frame: Baseline, up to 2 months post-implant
Change in Hand Motor Evoked Potential (MEP)
Change in Motor Evoked Potential (MEP): MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).
Time frame: Baseline, up to 2 months post-implant
Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP): Standardized test to be measured on a scale from 0-116 through the combination of five subset scores to assess grasping ability at time points before and after implant. A composite score will be obtained for strength, muscle force and tasks. Higher scores indicate better hand motor function.
Time frame: Baseline, up to 2 months post-implant
Change in Muscle Coordination Measured by Electromyography (EMG)
Functional tasks: Assessments to measure reaching ability and obtain muscle coordination via EMG (millivolts).
Time frame: Baseline, up to 2 months post-implant
Change in Movement Kinematics
Kinematics data (motion capture, measured in centimeters) at time points before and after implant.
Time frame: Baseline, up to 2 months post-implant
Change in Muscle Strength
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Neural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices.
Muscle force testing: Assessment of changes in muscle strength from measured in Newtons at time points before and after implant.
Time frame: Baseline, up to 2 months post-implant
Change in Quality of Life
Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL): ISCI-QOL consists of three single items on satisfaction with life as a whole, physical health, and psychological health using a 0-10 scale where 0=complete dissatisfaction; 10=complete satisfaction. A composite score will be obtained for this measure.
Time frame: Baseline, up to 2 months post-implant
Change in Independence Measured by Spinal Cord Independence Measure (SCIM III)
Independence as measured by Spinal Cord Independence Measure (SCIM III): SCIM III assesses performance in activities of daily living Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.
Time frame: Baseline, up to 2 months post-implant
Change in Satisfaction of Life
Medical Outcomes Study Short Form 36 (SF-36): Patient-reported outcome measurement for health-related quality of life and activities of daily living scored on a scale of 0 (negative health) to 100 (positive health).
Time frame: Baseline, up to 2 months post-implant
Change in Pain Levels
Brief Pain Inventory (BPI): A questionnaire for pain will be assessed on a scale of 0 ("no pain") to 10 ("worst imaginable pain") at different points before and after the implant.
Time frame: Baseline, up to 2 months post-implant