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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsal Spinal Nerve Root Stimulation | Experimental | Individuals undergoing cervical spinal surgery will receive direct electrical stimulation to the cervical dorsal spinal nerve roots. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar Neural Stimulation Electrode | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Circuit Excitability | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Transmission to the Brain | 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter C Gerszten, MD | Contact | 412-647-0958 | gerspc@upmc.edu | |
| Elvira Pirondini, PhD | Contact | 412-636-0595 | elvirap@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter C Gerszten, MD | University of Pittsburgh, Neurological Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
Data will become available at the end of the trial upon publication of the first manuscript. Estimation is 5 years from enrollment of the first participant.
Data must be directly requested from the PI and will be shared upon completion of the necessary data-sharing agreement to protect confidential patient information.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002493 | Central Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D009069 | Movement Disorders |
| D009461 | Neurologic Manifestations |
| D013118 | Spinal Cord Diseases |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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This is a prospective, controlled, open-label, experimental study.
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| D014947 |
| Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |