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HRV in Patients Treated With Spinal Cord Stimulation

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ClinicalTrials.gov Identifier: NCT03768791
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Moens Maarten, Universitair Ziekenhuis Brussel

Brief Summary:
This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Other: SCS is switched off Other: SCS is switched on Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 30, 2019

Arm Intervention/treatment
Experimental: SCS off Other: SCS is switched off
Spinal cord stimulator is switched off for 12 hours

Experimental: SCS on Other: SCS is switched on
Spinal cord stimulator is on




Primary Outcome Measures :
  1. Heart rate variability 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 heart rate variability between both measurements (SCS on versus SCS off)


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).
  • The use of medication that directly modifies autonomic control (for example beta-blockers).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768791


Contacts
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Contact: Maarten Moens, Prof. dr. +32 2 477 55 14 maarten.moens@uzbrussel.be
Contact: Lisa Goudman, Msc. +32 2 477 55 14

Locations
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Belgium
UZ Brussel Recruiting
Jette, Brussel, Belgium, 1090
Contact: Maarten Moens, Prof. dr.    +32 2 477 55 14    maarten.moens@uzbrussel.be   
Sponsors and Collaborators
Moens Maarten
Investigators
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Principal Investigator: Maarten Moens, Prof. dr. Universitair Ziekenhuis Brussel

Publications:
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Responsible Party: Moens Maarten, principal investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03768791     History of Changes
Other Study ID Numbers: SYNCHRO
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moens Maarten, Universitair Ziekenhuis Brussel:
Spinal Cord Stimulation
Heart rate variability

Additional relevant MeSH terms:
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Syndrome
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Postoperative Complications
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms