Back to resultsChanges in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain
Primary Purpose
Pain, Low Back Pain, Leg Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precision Spinal Cord Stimulation and PET Scan
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Neurostimulation
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Center for Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Precision Spinal Cord Stimulation and PET Scan
Arm Description
Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.
Outcomes
Primary Outcome Measures
Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off
Secondary Outcome Measures
Cerebral Blood Flow and VAS With Partial Paresthesia Coverage and Subthreshold Stimulation Compared With Optimal Coverage and With SCS Off
Full Information
NCT ID
NCT00418301
First Posted
January 2, 2007
Last Updated
March 29, 2022
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00418301
Brief Title
Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2007 (Actual)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Low Back Pain, Leg Pain
Keywords
Pain, Neurostimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Precision Spinal Cord Stimulation and PET Scan
Arm Type
Experimental
Arm Description
Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.
Intervention Type
Other
Intervention Name(s)
Precision Spinal Cord Stimulation and PET Scan
Intervention Description
Imaging procedure to assess spinal Cord Stimulation.
Primary Outcome Measure Information:
Title
Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off
Time Frame
Within a few hours
Secondary Outcome Measure Information:
Title
Cerebral Blood Flow and VAS With Partial Paresthesia Coverage and Subthreshold Stimulation Compared With Optimal Coverage and With SCS Off
Time Frame
Within a few hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Rauck, MD
Organizational Affiliation
Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain
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