Recruiting

Spinal Cord Stimulation

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07095036

Conditions

Pain Management

Pain, Intractable

Pain, Chronic Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal cord stimulation (SCS)

Study Details

Brief summary:

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.

Conditions

Pain Management

Pain, Intractable

Pain, Chronic Disease

Study ID

NCT07095036

Start date

Jan 6, 2026

Status verified date

Dec, 2025

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Assessing sensations using spinal cord stimulation

Interventions

Spinal cord stimulation (SCS)

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 outcome measure

  • Threshold amplitude for sensory perception evoked by spinal stimulation [ Time Frame: From lead implantation to lead explantation at one week ]
  • 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 ]

Central Contacts and Locations

Locations

Ambulatory Care Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Jacob Slack

269-362-4203jcslack@email.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Feb 4, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-02-04.