Recruiting

Neurological Assessment

Sponsor:

Peter C. Gerszten, MD

Code:

NCT07401186

Conditions

Stroke

Able Bodied

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Bipolar Neural Stimulation Electrode

Study Details

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

Study ID

NCT07401186

Start date

May 26, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Dorsal Spinal Nerve Root Stimulation

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

Interventions

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.

Primary outcome measure

  • Spinal Circuit Excitability [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Peter C Gerszten, MD

412-647-0958gerspc@upmc.edu

Elvira Pirondini, PhD

412-636-0595elvirap@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Peter C Gerszten, MD

412-647-0958gersztenpc@upmc.edu

Sydney Bader

412-648-4196

Principal Investigator:

Peter C Gerszten, MD

More Information

Sponsor

Peter C. Gerszten, MD

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Peter C. Gerszten, MD on 2026-06-04.