Neck nerve stimulation to map spinal and brain sensory pathways
Stimulation Evoked Primary Afferent Depolarization to Modulate Sensory Transmission to Spinal Motoneurons and the Sensory Cortex
NA · University of Pittsburgh · NCT07401186
We will test whether brief electrical pulses applied to neck nerve roots can reveal spinal and brain sensory responses in people with chronic stroke and control patients undergoing cervical surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07401186 on ClinicalTrials.gov |
What this trial studies
During surgery investigators will deliver single and paired electrical pulses to dorsal root fibers at multiple frequencies using FDA-cleared stimulation equipment. They will record evoked motor responses from arm and hand muscles with intramuscular EMG and record cortical sensory potentials with intraoperative EEG. Participants include adults aged 21–75 with chronic (≥6 months) single ischemic or hemorrhagic stroke causing hemiparesis who are undergoing a cervical epidural lead implant or decompressive cervical surgery, plus control patients undergoing elective posterior cervical decompressive surgery with routine monitoring. The goal is to characterize changes in spinal sensory-modulating circuitry after stroke by comparing stimulation-evoked responses between groups.
Who should consider this trial
Good fit: Ideal candidates are adults 21–75 years old with a single ischemic or hemorrhagic stroke at least six months earlier causing hemiparesis who are scheduled for a cervical epidural lead implant or elective posterior cervical decompressive surgery, or control patients having similar cervical surgery with intraoperative monitoring.
Not a fit: Patients with other neurological diseases, those outside the 21–75 age range, or those not undergoing the specified cervical surgical procedures are unlikely to qualify or directly benefit from participation.
Why it matters
Potential benefit: If successful, this approach could clarify how spinal sensory circuits change after stroke and help guide targeted neuromodulation treatments to improve arm and hand function.
How similar studies have performed: Intraoperative electrophysiological mapping of spinal and cortical responses has been used successfully in other settings, but applying these measures specifically to compare spinal sensory modulation after stroke is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 exclusion criteria: pregnancy and other clinical conditions eligible for surgery. * Participants must not be on anti-spasticity or anti-epileptic medications.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Peter C Gerszten, MD — University of Pittsburgh, Neurological Surgery
- Study coordinator: Peter C Gerszten, MD
- Email: gerspc@upmc.edu
- Phone: 412-647-0958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Able Bodied, Central Nervous System Disease, Cerebrovascular Disorder, Brain Injury, Brain Disease, Movement Disorder, Nervous System