Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury Cervical
Conditions
Keywords
spinal cord injury, tetraplegia, intracortical microstimulation, peripheral nerve stimulation
Brief summary
The goal of this clinical trial is to learn more about how stimulating the nerves involved in sensation (either in the limbs or in the brain) can be used to restore sensation in participants who have a spinal cord injury. Participants in this study will have already been enrolled in the "Reconnecting the Hand and Arm to the Brain (ReHAB)" study, and received small electrodes in a part of the brain that is involved in sensing touch and pressure in the hand. The ReHAB study participants will also have received electrodes around the nerves in their arm. In this clinical trial, participants will receive two types of electrical stimulation: * Intracortical microstimulation (ICMS) which involves sending small electrical pulses to the part of the brain that processes sensation. * Peripheral nerve stimulation (PNS) which involves sending small electrical pulses to the nerves in the arm that transmit sensations from the hand. Researchers will try different patterns of stimulation for both ICMS and PNS and study how the participants perceive the sensations from the different stimulation patterns. The researchers will also study how combining ICMS and PNS affects the perceived sensations.
Detailed description
The overall goal of this study is to compare the sensations that are perceived from intracortical microstimulation (ICMS) to those perceived from peripheral nerve stimulation (PNS), and also to perceived sensations from a combination of ICMS and PNS. Preceding study Participants for this study will be individuals with a high-level spinal cord injury who are already enrolled in the "Reconnecting the Hand and Arm to the Brain (ReHAB)" clinical trial (ID# NCT03898804). The ReHAB clinical trial involves receiving tiny electrode arrays in the brain and small electrodes around some of the nerves in the arm. The goal of the ReHAB clinical trial is to restore arm and hand movement and sensation in individuals with paralysis from a spinal cord injury. Goals of this clinical trial The purpose of the proposed study is to investigate the perception and functional impact of sensory neurostimulation in participants with tetraplegia. Investigators will develop and implement novel paradigms of ICMS applied to primary somatosensory cortex (S1) and PNS applied to upper extremity nerves through chronically-implanted cuff electrodes. Investigators will also develop and assess hybrid neurostimulation paradigms involving paired application of ICMS and PNS. For each paradigm, investigators will quantify the perceived sensation with classic psychophysical methods. Investigators will also implement the approach into closed-loop tasks in virtual reality controlled through decoded cortical signals recorded from intracortical microelectrode arrays. Finally, investigators will assess the impact of each stimulation paradigm on residual sensory function. In Aim 1, investigators will develop a novel ICMS paradigm that attempts to reproduce both the temporal and spatial activation patterns that occur in S1 during normal touch. Investigators will compare this novel paradigm to other existing ICMS encoders. Investigators will assess the impact of each ICMS encoder on perceptual response, task performance in virtual reality (VR), and residual sensory function. In Aim 2, investigators will develop novel PNS paradigms and assess the efficacy of PNS for sensory feedback in people with tetraplegia for the first time. As in Aim 1, investigators will develop and compare several PNS encoders, including those that reproduce aspects of the peripheral response to normal touch and traditional linear encoders. We will assess the impact of each PNS encoder on perceptual response, task performance in VR, and residual sensory function. In Aim 3, we will develop hybrid neurostimulation paradigms that pair ICMS with PNS. We will assess the impact of stimulation encoder and stimulation amplitude on the perceived sensations generated by hybrid stimulation. We will then investigate the impact of PNS-ICMS timing delays within the hybrid neurostimulation paradigm on the perceptual response, functional impact, and impact on residual sensory function. All participants will participate in all aims and will receive all stimulation approaches and perform all tasks and measures. All participants will serve as their own control for the planned statistical analyses. The study will generate tens of thousands of perceptual response data points, hundreds of functional task data points, and hundreds of thousands of intracortical recordings (for exploratory analyses).
Interventions
DEVICEBrain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system
Participants with tetraplegia who have received intracortical arrays in the sensory cortex and peripheral nerve cuff electrodes will undergo a variety of stimulation paradigms to investigate the perception and functional impact of sensory neurostimulation.
Sponsors
Case Western Reserve University
University Hospitals Cleveland Medical Center
Cleveland Clinic Lerner Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery. 2. Willingness and availability to follow the study protocol.
Exclusion criteria
1. Lack of function or operability of all implanted ReHAB system components 2. Severe pain or other chronic medical condition that would prevent the participant from completing study-related activities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Force matching success rate | From enrollment to around two years after enrollment | Percentage of force matching trials per block in which the target force was achieved before the time limit |
| Object discrimination accuracy | From enrollment to around two years after enrollment | Percentage of trials per block in which the correct object was identified |
| Discrimination threshold | From enrollment until around two years post-enrollment | Minimal change in stimulation that results in a reliably distinguishable change in perceived magnitude |
| Tactor detection threshold | From enrollment to around two years after enrollment | Minimal mechanical stimulus, delivered by a tactor that the participant can reliably perceive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory dynamic range | From enrollment until around two years post-enrollment | Difference in minimum and maximum stimulation levels that elicit detectable, comfortable sensation |
| Projected field location | From enrollment until around two years post-enrollment | The position of the sensory percept reported on a hand/arm diagram |
| Sensation quality | From enrollment to around two years after enrollment | The participant's description of the quality of the sensation evoked by stimulation, reported as a selection of descriptor words |
| Naturalness rating | From enrollment until around two years post-enrollment | The participant's rating of the perceived naturalness of the stimulus on an open-ended scale |
| Tactor discrimination threshold | From enrollment to around two years after enrollment | Minimal change in mechanical touch input that results in a reliably distinguishable change in perceived magnitude |
| Force matching time to target | From enrollment to around two years after enrollment | The time elapsed from the go cue required for the participant to hit the force target |
| Posture matching success rate | From enrollment to around two years after enrollment | Percentage of posture matching trials per block in which the target posture was achieved before the time limit |
Countries
United States
Contacts
CONTACTEmily Graczyk, Ph.D.
PRINCIPAL_INVESTIGATOREmily Graczyk, Ph.D.
Case Western Reserve University
Outcome results
None listed