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Microneurography and Spinal Cord Stimulation in Chronic Visceral Pain (AFTSCSCVP)

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ClinicalTrials.gov Identifier: NCT00678717
Recruitment Status : Terminated (Lack of funding)
First Posted : May 15, 2008
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University Medical Center

Brief Summary:
The purpose of this study is to assess the effect of the spinal cord stimulator (A small wire is surgically implanted under the skin. Low-level electrical signals are then transmitted through the lead to the spinal cord to alleviate pain. Using a magnetic remote control, the patients can turn the current on and off, or adjust the intensity.) on the autonomic nervous system (sympathetic and parasympathetic). Some studies support that the spinal cord stimulation suppresses or decreases sympathetic outflow (the sympathetic nervous system is the one that provide us with the "flight and fight response" and the parasympathetic nervous system is the one that works while we "sleep, rest and digest".). The sympathetic nervous system is important in blood pressure regulation also. However, there are not reports regarding the effect of the spinal cord stimulation on blood pressure regulation in chronic visceral pain patients. Most clinical trials are focus on the effect of the spinal cord stimulation on pain relief. We think we could use blood pressure, heart rate and special analysis of these signals and their relationship to other pain measurements to assess the effect of the spinal cord stimulation in an objective way.

Condition or disease Intervention/treatment Phase
Chronic Pain Procedure: Autonomic Evaluation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Autonomic Function Testing and Spinal Cord Stimulation: Implications for Successful Therapy in Chronic Visceral Pain
Actual Study Start Date : February 2008
Actual Primary Completion Date : January 23, 2009
Actual Study Completion Date : January 23, 2009

Arm Intervention/treatment
Active Comparator: Healthy
Healthy volunteers
Procedure: Autonomic Evaluation
Orthostatic vital signs will be determined by measuring heart rate (HR) and brachial blood pressure (BP) during a tilt table test. The degree of vagal mediated sinus arrhythmia will be assessed during controlled breathing (5 seconds inhalation and 5 seconds exhalation during 90 seconds), and the sinus arrhythmia parameters will be calculated as the difference and ratio of the longest to the shortest RR interval. The sympathetic response during breath hold will be measured. Responses of BP, HR, MSNA will be acquired during Valsalva maneuver. The valsalva ratio of heart rate will be calculated from the maximum of heart rate during or shortly after straining and the minimal depressed heart rate in the overshoot phase IV. Blood pressure and MSNA increase during isometric handgrip maintained at 30% of maximal voluntary contraction for five minutes will be determined. The blood pressure and MSNA response will be measured during cold pressor test with the hand in ice water for 1 minute.
Experimental: Chronic Visceral Pain
Chronic Visceral Pain patients. Participants will be tested before and after implantation of a Spinal Cord Stimulator (implantation of the Spinal Cord Stimulator is done as usual care and is not a study procedure)
Procedure: Autonomic Evaluation
Orthostatic vital signs will be determined by measuring heart rate (HR) and brachial blood pressure (BP) during a tilt table test. The degree of vagal mediated sinus arrhythmia will be assessed during controlled breathing (5 seconds inhalation and 5 seconds exhalation during 90 seconds), and the sinus arrhythmia parameters will be calculated as the difference and ratio of the longest to the shortest RR interval. The sympathetic response during breath hold will be measured. Responses of BP, HR, MSNA will be acquired during Valsalva maneuver. The valsalva ratio of heart rate will be calculated from the maximum of heart rate during or shortly after straining and the minimal depressed heart rate in the overshoot phase IV. Blood pressure and MSNA increase during isometric handgrip maintained at 30% of maximal voluntary contraction for five minutes will be determined. The blood pressure and MSNA response will be measured during cold pressor test with the hand in ice water for 1 minute.



Primary Outcome Measures :
  1. Muscle sympathetic nerve activity [ Time Frame: Prior to stimulator implant and within 1 year of receiving stimulator implant ]
    Microneurography directly assesses muscle sympathetic nerve activity (MSNA)


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: Before and up to 1 year after spinal cord stimulator implant ]
    Participants in both arms will be tested at baseline and again within 1 year. Participants in the Chronic Visceral Pain arm will be tested after implantation of a Spinal Cord Stimulator

  2. blood pressure [ Time Frame: Before and up to 1 year after spinal cord stimulator implant ]
    Participants in both arms will be tested at baseline and again within 1 year. Participants in the Chronic Visceral Pain arm will be tested after implantation of a Spinal Cord Stimulator



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chronic visceral pain patients candidates for spinal cord stimulation implant with no other chronic diseases.

Exclusion Criteria:

  • Diabetes, pulmonary or chronic cardiac diseases.

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): NCT00678717


Locations
United States, Tennessee
Interventional Pain Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Sukdeb Datta, M.D. Vanderbilt University

Responsible Party: Peter Konrad, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00678717     History of Changes
Other Study ID Numbers: 071179
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Peter Konrad, Vanderbilt University Medical Center:
abdominal
Pelvic
Pain
SCS
Healthy and Chronic Visceral Pain patients
Chronic Visceral Pain and spinal cord stimulator

Additional relevant MeSH terms:
Chronic Pain
Visceral Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nociceptive Pain