Stimulation-Based Modulation of Spinal and Cortical Sensory Pathways
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorPeter C. Gerszten, MD
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 exclusion criteria: pregnancy and other clinical conditions eligible for surgery.
Participants must not be on anti-spasticity or anti-epileptic medications.
Trial design
Design model
Single group
Treatments tested in this trial
Bipolar Neural Stimulation Electrode
DeviceAll 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Dorsal Spinal Nerve Root StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 daySecondary outcomes
1
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.
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Peter C. Gerszten, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov