Leg Pain, Low Back Pain, Pain
Conditions
Keywords
Pain, Neurostimulation
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.
Interventions
OTHERPrecision Spinal Cord Stimulation and PET Scan
Imaging procedure to assess spinal Cord Stimulation.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off | Within a few hours |
Secondary
| Measure | Time frame |
|---|---|
| Cerebral Blood Flow and VAS With Partial Paresthesia Coverage and Subthreshold Stimulation Compared With Optimal Coverage and With SCS Off | Within a few hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Precision Spinal Cord Stimulation and PET Scan Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation.
Precision Spinal Cord Stimulation and PET Scan: Imaging procedure to assess spinal Cord Stimulation. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off
Time frame: Within a few hours
Population: Efforts were made but the information is not accessible at this time. Hence outcome measures are not reported.
Secondary
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
Population: Efforts were made but the information is not accessible at this time. Hence outcome measures are not reported.