Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418301
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2007-01-02
Brief Title:
Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None