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Autonomic Function Testing and Spinal Cord Stimulation in Chronic Visceral Pain (AFTSCSCVP)

This study has been terminated.
(Lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678717
First Posted: May 15, 2008
Last Update Posted: September 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
  Purpose
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 Intervention Phase
Chronic Pain Device: "Sham" Device: Medtronic or ANS spinal cord stimulator Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Autonomic Function Testing and Spinal Cord Stimulation: Implications for Successful Therapy in Chronic Visceral Pain

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • MSNA [ Time Frame: Before and after spinal cord stimulator implant ]

Secondary Outcome Measures:
  • Heart rate and blood pressure [ Time Frame: Before and after spinal cord stimulator ]

Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Healthy
Healthy volunteers
Device: "Sham"
Physiological stimuli
Active Comparator: Chronic Visceral Pain
Patients
Device: Medtronic or ANS spinal cord stimulator
Spinal cord stimulator implant

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
Investigators
Principal Investigator: Sukdeb Datta, M.D. Vanderbilt University
  More Information

Responsible Party: Sukdeb Datta M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00678717     History of Changes
Other Study ID Numbers: 071179
CTSA1 UL 1RR024975 NCRR/NIH
First Submitted: May 8, 2008
First Posted: May 15, 2008
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by Vanderbilt University:
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