Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation

Overview

This study is investigating skin conductance and respiration during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2020

Interventions

  • Other: SCS is switched off
    • Spinal cord stimulator is switched off for 12 hours
  • Other: SCS is switched on
    • Spinal cord stimulator is on

Arms, Groups and Cohorts

  • Experimental: SCS off
  • Experimental: SCS on

Clinical Trial Outcome Measures

Primary Measures

  • Skin conductance changes
    • Time Frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]
    • The investigators will examine the difference in skin conductance between both measurements (SCS on versus SCS off)
  • Respiration
    • Time Frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]
    • The investigators will examine the difference in respiration between both measurements (SCS on versus SCS off)

Secondary Measures

  • Pain intensity scores
    • Time Frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]
    • Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is at least 18 years old.
  • Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
  • Cognitive and language functioning enabling coherent communication between the examiner and the participant.

Exclusion Criteria

  • Patients with impaired skin integrity at the fingers.
  • Patients with major psychiatric problems.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Moens Maarten
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Moens Maarten, Principal Investigator – Universitair Ziekenhuis Brussel
  • Overall Official(s)
    • Maarten Moens, Prof. dr., Principal Investigator, Universitair Ziekenhuis Brussel

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