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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision Spinal Cord Stimulation and PET Scan | Experimental | Positron emission tomography (PET) scan imaging procedures to assess Spinal Cord Stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Spinal Cord Stimulation and PET Scan | Other | Imaging procedure to assess spinal Cord Stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off | Within a few hours |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Rauck, MD | Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Efforts were made but the information is not accessible at this time. Hence baseline measures are not reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off | Efforts were made but the information is not accessible at this time. Hence outcome measures are not reported. | Posted | Within a few hours |
|
|
Adverse events were collected from enrollment through end of study.
Efforts were made but the information is not accessible at this time. Hence adverse events not reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Sciences | Boston Scientific | 6619494350 | roshini.jain@bsci.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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|
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| Secondary | Cerebral Blood Flow and VAS With Partial Paresthesia Coverage and Subthreshold Stimulation Compared With Optimal Coverage and With SCS Off | Efforts were made but the information is not accessible at this time. Hence outcome measures are not reported. | Posted | Within a few hours |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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