Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
Healthy Volunteers
ID07401186

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

Led by Peter C. Gerszten, MD · Updated on 2026-06-04

15

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how cervical (neck) nerve roots can be stimulated during surgery to observe reflex responses in spinal motor neurons. This investigation focuses on understanding how sensory pathways in the spine and brain are affected, especially in neurological conditions like stroke, which can change spinal sensory circuits and cause movement difficulties. Participants will undergo electrical stimulation of the dorsal cervical spinal nerve roots during cervical spinal surgery. This is done using an FDA-cleared bipolar neural stimulation electrode, which is commonly used to monitor nerve function during such procedures. Muscle activity will be recorded with intramuscular electromyography (EMGs), and sensory responses in the brain will be measured using intra-operative EEGs to assess how sensory information is transmitted. During the study, participants will have motor and sensory responses measured in real time while the nerve roots are stimulated. The primary focus is on spinal circuit excitability and sensory transmission to the brain, assessed on the day of surgery. The study includes detailed monitoring of muscle and brain activity to better understand sensory modulation. The total participation time aligns with the surgical procedure and intra-operative assessments.

CONDITIONS

Brief Title

Stimulation-Based Modulation of Spinal and Cortical Sensory Pathways

Who Can Participate

Age: 21Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages between 21 and 75 years
  • Control subjects undergoing elective posterior cervical spinal surgery including decompressive laminectomy with standard electrophysiological monitoring
  • Stroke subjects with a single ischemic or hemorrhagic stroke over 6 months ago causing hemiparesis and undergoing cervical epidural lead implant or elective posterior cervical spinal surgery with electrophysiological monitoring
Not Eligible

You will not qualify if you...

  • Known neurological diseases other than stroke such as amyotrophic lateral sclerosis, spinal muscular atrophy, spinal cord injury, autoimmune neuropathy, or sensory nerve disorders
  • Not eligible for surgery, including pregnancy and other clinical conditions affecting surgery eligibility
  • Current use of anti-spasticity or anti-epileptic medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Implementation

Duration - Surgery day

Participants undergoing cervical spinal surgery receive direct electrical stimulation to the cervical dorsal spinal nerve roots using a bipolar neural stimulation electrode while muscle activity and sensory signals are recorded.

1 surgical visit (in-person)

Trial Site Locations

Total: 1 location

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

P

Peter C Gerszten, MD

E

Elvira Pirondini, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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