Stimulation-Based Modulation of Spinal and Cortical Sensory Pathways

NCT07401186 | Recruiting FDA Device

• 1 other identifier: STUDY25040076
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Able Bodied

Keywords

Central Nervous System Disease; Cerebrovascular Disorder; Brain Injury; Brain Disease; Movement Disorder; Nervous System; Stroke; Spinal Cord Disease; Nervous System Disease; Sensorimotor Disorder

Outcome Measures

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.

  1 day

Secondary Outcomes (1)

• Sensory Transmission to the Brain

  1 day

Study Arms (1)

Dorsal Spinal Nerve Root Stimulation

EXPERIMENTAL

Individuals undergoing cervical spinal surgery will receive direct electrical stimulation to the cervical dorsal spinal nerve roots.

Device: Bipolar Neural Stimulation Electrode

Interventions

Bipolar Neural Stimulation Electrode DEVICE

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.

Dorsal Spinal Nerve Root Stimulation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter C. Gerszten, MD: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Central Nervous System Diseases; Cerebrovascular Disorders; Brain Injuries; Brain Diseases; Movement Disorders; Neurologic Manifestations; Spinal Cord Diseases; Nervous System Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter C Gerszten, MD

  University of Pittsburgh, Neurological Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter C Gerszten, MD

CONTACT

412-647-0958; gerspc@upmc.edu

Elvira Pirondini, PhD

CONTACT

412-636-0595; elvirap@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective, controlled, open-label, experimental study.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 10, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)