Neck nerve stimulation to map spinal and brain sensory pathways

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.