Pain, Chronic Disease, Pain, Intractable, Pain Management
Conditions
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.
Interventions
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.
Sponsors
University of North Carolina, Chapel Hill
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Threshold amplitude for sensory perception evoked by spinal stimulation | 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. |
| Change in amplitude to perceive a just-noticeable difference in sensory perception evoked by spinal stimulation | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmol Yadav, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed