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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00418301 |
The primary objective of this study is to identify the brain regions in which activity is affected by SCS. Baseline cerebral blood flow scans with the device turned off will be generated compared to scans produced with the device operating at parameters which produce optimal coverage of the painful areas. The relationship between cerebral blood flow and pain rating scores will be evaluated in both conditions.
Condition | Intervention | Phase |
---|---|---|
Pain Low Back Pain Leg Pain |
Other: Precision Spinal Cord Stimulation and PET Scan |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Changes in Regional Cerebral Blood Flow as an Indicator of Neuronal Activity in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain |
Estimated Enrollment: | 15 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Spinal Cord Stimulation (SCS) is known to be effective in pain management. Some evidence exists that SCS may cause changes in cerebral blood flow. This study will be a novel PET examination of activity in brain regions affected by SCS. This activity will be compared with the pain intensity and distribution. Further, by examining cerebral blood flow at different doses of stimulation, relationships between SCS, brain perfusion, and pain relief can be drawn. This study will contribute to the elucidation of the mechanism of action of SCS.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lyn Pimentel, MBA | 661.949.4174 | Lyn.Pimentel@bsci.com |
United States, North Carolina | |
Center for Clinical Research | Recruiting |
Winston Salem, North Carolina, United States, 27103 | |
Contact: Terri Monroe 336-714-8381 Tmonroe@ccrpain.com | |
Principal Investigator: Richard Rauck, MD |
Principal Investigator: | Richard Rauck, MD | Center for Clinical Research |
Responsible Party: | Boston Scientific Corporation ( Lyn Pimentel, Clinical Project Manager ) |
Study ID Numbers: | SCS0305 |
Study First Received: | January 2, 2007 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00418301 |
Health Authority: | United States: Institutional Review Board |
Pain Neurostimulation |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Nervous System Diseases |