Assessment of Neural Signals for the Control of Assistive Devices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury (SCI), Initial Encounter
- Sponsor
- University of Miami
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Change in Hand Motor Evoked Potential (MEP)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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).
Investigators
Jonathan Jagid
Professor of Neurological Surgery
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Patients age 18 and older
- •Able to sign informed consent
- •Not participating in other studies that limit participation
- •Chronic (\>6 month) traumatic Spinal Cord Injury (SCI) (C4-T1 neurological injury with American Spinal Injury Association Impairment Scale (AIS A-D) with some residual function.
Exclusion Criteria
- •Patients that are pregnant
- •Patients under the age of 18
- •Patients unable to provide informed consent
Outcomes
Primary Outcomes
Change in Hand Motor Evoked Potential (MEP)
Time Frame: Baseline, up to 2 months post-implant
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).
Change in Hand Motor Function
Time Frame: Baseline, up to 2 months post-implant
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.
Secondary Outcomes
- Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)(Baseline, up to 2 months post-implant)
- Change in Muscle Coordination Measured by Electromyography (EMG)(Baseline, up to 2 months post-implant)
- Change in Quality of Life(Baseline, up to 2 months post-implant)
- Change in Satisfaction of Life(Baseline, up to 2 months post-implant)
- Change in Movement Kinematics(Baseline, up to 2 months post-implant)
- Change in Pain Levels(Baseline, up to 2 months post-implant)
- Change in Muscle Strength(Baseline, up to 2 months post-implant)
- Change in Independence Measured by Spinal Cord Independence Measure (SCIM III)(Baseline, up to 2 months post-implant)