Sensory Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subjects with high risk of falling
Refusal to participate in study
Subjects lacking consent capacity
Trial design
Design model
Single group
Treatments tested in this trial
Spinal cord stimulation (SCS)
Other interventionAfter 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Assessing sensations using spinal cord stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From lead implantation to lead explantation at one week2
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.
Time frame
From lead implantation to lead explantation at one weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov