Sensory Spinal Cord Stimulation
Generating Artificial Sensory Perceptions Using Spinal Cord Stimulation
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2025
CompletedFirst Posted
Study publicly available on registry
July 31, 2025
CompletedStudy Start
First participant enrolled
January 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
February 4, 2026
December 1, 2025
2.7 years
June 16, 2025
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Threshold amplitude for sensory perception evoked by spinal stimulation
The outcome measure will determine the threshold stimulation amplitude in microamperes required to evoke a perceivable sensory percept during spinal stimulation.
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
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.
From lead implantation to lead explantation at one week
Study Arms (1)
Assessing sensations using spinal cord stimulation
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with high risk of falling
- Refusal to participate in study
- Subjects lacking consent capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ambulatory Care Center
Chapel Hill, North Carolina, 27514, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amol Yadav, PhD
University of North Carolina, Chapel Hill
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
Study Record Dates
First Submitted
June 16, 2025
First Posted
July 31, 2025
Study Start
January 6, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
February 4, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- beginning 9 and continuing for 36 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.