Stimulation-Based Modulation of Spinal and Cortical Sensory Pathways for Stroke and Able-Bodied Individuals

This study is looking at how electrical stimulation affects the nerves in your neck and how those nerves connect to your brain and muscles. Researchers will use an FDA-cleared device called a Bipolar Neural Stimulation Electrode to deliver electrical pulses to your spinal nerves. They will then measure muscle activity using small needles (intramuscular EMGs) and brain activity (intra-op EEGs) to understand how these signals travel. The goal is to learn more about how stroke changes these nerve pathways. You may be eligible if you are between 21 and 75 years old and are either an able-bodied person having certain neck surgery or a stroke patient. The study aims to understand how nerve excitability in the spine changes over one day.

Study design
This interventional study plans to enroll 15 participants, including both individuals who have had a stroke and able-bodied individuals.
What's involved
All participants will receive electrical stimulation to their dorsal cervical spinal nerves, during which muscle activities will be recorded through intramuscular EMGs and brain activity with intra-op EEGs.
Compensation
Not stated in the trial record.
Follow-up
Spinal Circuit Excitability will be measured at 1 day.

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NCT07401186

Stimulation-Based Modulation of Spinal and Cortical Sensory Pathways

Recruiting
NAAges 21–75InterventionalBasic science
Peter C. Gerszten, MD
~15 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Bipolar Neural Stimulation Electrode

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Spinal Circuit Excitability
Measured over 1 day
Stroke
Able Bodied
1 sites across 1 states
Pennsylvania1
  • Peter C Gerszten, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh, Neurological Surgery

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Eligibility criteria

Inclusion

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

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.
Participants must not be on anti-spasticity or anti-epileptic medications.
  • Spinal Circuit Excitability1 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.