Able Bodied, Stroke
Conditions
Keywords
Central Nervous System Disease, Cerebrovascular Disorder, Brain Injury, Brain Disease, Movement Disorder, Nervous System, Stroke, Spinal Cord Disease, Nervous System Disease, Sensorimotor Disorder
Brief summary
The goal of this study is to assess cervical (neck) reflexes by intra-operatively stimulating the neck nerve roots to evoke motor responses through their connections to spinal motoneurons. This data is critical to reveal changes to the spinal sensory modulating circuitry in neurological disorders like stroke.
Detailed description
Spinal afferents continuously convey sensory information on limb movements to the central nervous system which not only gives people conscious experience of movement, but also plays a major role in shaping motor output through monosynaptic afferent-motoneuronal connections. Stroke induces changes in the spinal circuitry modulating this sensory input, leading to sensorimotor deficits. Specifically, the investigators will 1) activate the dorsal root fibers with single and double electrical stimulation pulses at various frequencies using FDA-cleared devices, 2) quantify the stimulation evoked motor potentials in arm and hand muscles recorded with intramuscular EMGs, 3) quantify stimulation evoked sensory potentials in the cortex with intra-op EEGs.
Interventions
DEVICEBipolar Neural Stimulation Electrode
All individuals enrolled in this study will receive electrical stimulation to the dorsal cervical spinal nerves using the FDA-cleared bipolar stimulating electrode routinely used as standard-of-care to monitor neural function, during which muscle activities will be recorded through intramuscular electromyography (EMGs), and sensory evoked cortical local field potentials (SSEPs) will be acquired simultaneously to characterize properties of the spinal sensory pathways.
Sponsors
Peter C. Gerszten, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
This is a prospective, controlled, open-label, experimental study.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* All Subjects: Ages between 21 and 75 years. The minimum age is selected to age match control subjects with stroke subjects. In addition, participants outside this age range may be at an increased medical risk. * Control subjects: Patients undergoing elective posterior cervical spinal surgery that includes a decompressive laminectomy, and who will have electrophysiological monitoring performed as part of the standard of care for their procedure. * Stroke subjects: Participants must have a suffered a single, ischemic or hemorrhagic stroke more than 6 months prior to the time of enrollment with hemiparesis as a result, is undergoing a cervical epidural lead implant or undergoing elective posterior cervical spinal surgery that includes a decompressive laminectomy with electrophysiological monitoring performed as part of the standard of care.
Exclusion criteria
* Patients will be excluded from the study if they have any known neurological diseases other than stroke, such as amyotrophic lateral sclerosis, spinal muscular atrophy, spinal cord injury, autoimmune neuropathy, or sensory nerve disorders, that may affect the integrity of cervical sensory afferents. * Only patients that are eligible for surgery will be enrolled. Therefore this automatically include as
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Circuit Excitability | 1 day | The investigators will record intramuscular electromyogram (EMG) of the hand and arm muscles evoked by dorsal nerve root stimulation at various frequencies to quantify spinal circuit excitability through the H-reflex. A mean difference of 10% from the baseline (first pulse per frequency) muscle activation will be considered a meaningful change in excitability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory Transmission to the Brain | 1 day | The investigators will use electroencephalograph (EEG) to record sensory stimulation evoked potentials (SSEP) from the brain during dorsal root stimulation at various frequencies to quantify sensory transmission efficiency. A mean difference of 10% from the baseline (first pulse per frequency) SSEP will be considered a meaningful change. |
Countries
United States
Contacts
CONTACTPeter C Gerszten, MD
CONTACTElvira Pirondini, PhD
PRINCIPAL_INVESTIGATORPeter C Gerszten, MD
University of Pittsburgh, Neurological Surgery
Outcome results
None listed