Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2026-01-06
2028-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Assessing sensations using spinal cord stimulation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Undergoing SCS implantation for treatment of chronic pain
* Subjects with ability to walk 10m without assistance
* Provides written consent for the study
Exclusion Criteria
* Refusal to participate in study
* Subjects lacking consent capacity
18 Years
85 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Amol Yadav, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Ambulatory Care Center
Chapel Hill, North Carolina, United States
Countries
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Facility Contacts
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Other Identifiers
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24-0213
Identifier Type: -
Identifier Source: org_study_id
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