Status:
COMPLETED
Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Pain
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 s...
Detailed Description
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 activit...
Eligibility Criteria
Inclusion
- Have had one or more back surgery procedures.
- Have used an active Precision SCS device for chronic low back and bilateral leg pain for at least 6 weeks.
- Have bilateral leg pain.
- Have a baseline VAS of \>4 (without stimulation).
- Have greater than 50% reduction in pain with SCS at optimal settings
- Be 18 years of age or older.
- Have the cognitive and functional capability to operate the controls for the device, to comply with directions during the study, and willing to participate in all study activities.
- Be capable of reading and understanding patient information materials and giving written informed consent.
Exclusion
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Have undergone a surgical lead revision or had any Precision components replaced after initial implantation.
- Are allergic to any of the injected media.
- Are pregnant or lactating.
- Have any contraindication to the PET scan procedure itself or exposure to the intravenous radioactive tracer (H215O).
- Have participated in any drug or device trial in the last 4 weeks or are currently participating in another drug or device trial.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00418301
Start Date
January 1 2007
End Date
April 1 2009
Last Update
March 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103