- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03768791
HRV in Patients Treated With Spinal Cord Stimulation
June 17, 2019 updated by: Moens Maarten
Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Brussel
-
Jette, Brussel, Belgium, 1090
- UZ Brussel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SCS off
|
Spinal cord stimulator is switched off for 12 hours
|
Experimental: SCS on
|
Spinal cord stimulator is on
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
December 21, 2018
Study Completion (Actual)
December 21, 2018
Study Registration Dates
First Submitted
November 28, 2018
First Submitted That Met QC Criteria
December 6, 2018
First Posted (Actual)
December 7, 2018
Study Record Updates
Last Update Posted (Actual)
June 18, 2019
Last Update Submitted That Met QC Criteria
June 17, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYNCHRO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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