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Recruiting NCT07095036

Sensory Spinal Cord Stimulation

No phase Interventional Pain Management Pain, Intractable Pain, Chronic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal cord stimulation (SCS).
Who it may be relevant to
Registry conditions: Pain Management, Pain, Intractable, Pain, Chronic Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Generating Artificial Sensory Perceptions Using Spinal Cord Stimulation

Overview

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

  • Other 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 (

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Ambulatory Care Center — Chapel Hill

Identifiers

NCT: NCT07095036 · 24-0213 · 7DP2NS136872-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗