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NCT Number: NCT07095036

Sensory Spinal Cord Stimulation

The purpose of this research study is to identify sensations that can be evoked with spinal cord stimulation (SCS) and to understand how these sensations change when stimulation parameters are modified.

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Key information

Conditions

Pain Management Agnosia Chronic Disease Disease Attributes Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Chronic Disease Pain, Intractable Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatory Care Center

Chapel Hill, North Carolina, 27514, United States

Location status: Recruiting

Location contact

Jacob Slack

CONTACT

[email protected]

269-362-4203

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients 18-85 years old
  • Undergoing SCS implantation for treatment of chronic pain
  • Subjects with ability to walk 10m without assistance
  • Provides written consent for the study

Exclusion criteria

  • Subjects with high risk of falling
  • Refusal to participate in study
  • Subjects lacking consent capacity

Treatment and study plan

Spinal cord stimulation (SCS)

Other

After implantation of SCS trial leads - which is standard of care for evaluating whether SCS improves chronic pain - patients will visit clinic before the trial leads are explanted. During these visits, stimulation will be turned off and the leads will be disconnected from the clinical external pulse generator and reconnected to an external research stimulator. Patients will be seated in a chair and will interface with a touch-screen display where they will participate in a psychophysical task (a two-alternative forced-choice task). More specifically, the task will involve selecting between two options on a screen while spinal stimulation is delivered through the leads. As the patients perform the tasks, audio or video recordings will be made for future research analysis, education, or scientific communication. The research stimulator will also collect epidural signals through the stimulation leads.

Primary outcomes

  1. Threshold amplitude for sensory perception evoked by spinal stimulation

    Time frame: From lead implantation to lead explantation at one week

    The outcome measure will determine the threshold stimulation amplitude in microamperes required to evoke a perceivable sensory percept during spinal stimulation.

  2. Change in amplitude to perceive a just-noticeable difference in sensory perception evoked by spinal stimulation

    Time frame: From lead implantation to lead explantation at one week

    The outcome measure will determine the minimum change in stimulation amplitude in microamperes required to evoke a perceivable difference in sensory percepts during spinal stimulation.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Generating Artificial Sensory Perceptions Using Spinal Cord Stimulation

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 31, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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