HRV in Patients Treated With Spinal Cord Stimulation
Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2018
CompletedJune 18, 2019
June 1, 2019
20 days
November 28, 2018
June 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart rate variability changes
The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)
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.
Secondary Outcomes (1)
Pain intensity scores
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.
Study Arms (2)
SCS off
EXPERIMENTALSCS on
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
Study Sites (1)
UZ Brussel
Jette, Brussels Capital, 1090, Belgium
Related Publications (1)
Kalmar Z, Kovacs N, Balas I, Perlaki G, Plozer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6.
PMID: 23750425BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten Moens, Prof. dr.
Universitair Ziekenhuis Brussel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
November 28, 2018
First Posted
December 7, 2018
Study Start
December 1, 2018
Primary Completion
December 21, 2018
Study Completion
December 21, 2018
Last Updated
June 18, 2019
Record last verified: 2019-06