Clinical trial NCT00418301: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Low Back Pain
Leg Pain
Keywords: Pain
Neurostimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off
timeFrame: Within a few hours
Secondary outcomes:
measure: Cerebral Blood Flow and VAS With Partial Paresthesia Coverage and Subthreshold Stimulation Compared With Optimal Coverage and With SCS Off
timeFrame: Within a few hours
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
Study officials:
affiliation: Center for Clinical Research
name: Richard Rauck, MD
role: PRINCIPAL_INVESTIGATOR
References: