Stimulation-Based Modulation of Spinal and Cortical Sensory Pathways

Stimulation Evoked Primary Afferent Depolarization to Modulate Sensory Transmission to Spinal Motoneurons and the Sensory Cortex

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Able Bodied
• Intervention / Treatment: Device: Bipolar Neural Stimulation Electrode

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvira Pirondini, PhD; Phone Number: 412-636-0595; Email: elvirap@pitt.edu
• Study Contact Backup: Name: Peter C Gerszten, MD; Phone Number: 412-647-0958; Email: gerspc@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Peter C Gerszten, MD; Phone Number: 412-647-0958; Email: gersztenpc@upmc.edu
      • Contact: Sydney Bader; Phone Number: 412-648-4196
      • Principal Investigator: Peter C Gerszten, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dorsal Spinal Nerve Root Stimulation; Individuals undergoing cervical spinal surgery will receive direct electrical stimulation to the cervical dorsal spinal nerve roots.

Device: Bipolar Neural Stimulation Electrode; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peter C. Gerszten, MD
• Investigators: Principal Investigator: Peter C Gerszten, MD, University of Pittsburgh, Neurological Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Brain Disease; Brain Injury; Nervous System; Movement Disorder; Nervous System Disease; Spinal Cord Disease; Central Nervous System Disease; Cerebrovascular Disorder; Sensorimotor Disorder
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Neurologic Manifestations; Brain Injuries; Movement Disorders; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Spinal Cord Diseases
• Other Study ID Numbers: STUDY25040076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes