Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 7:19 AM
Study NCT ID:
NCT01261468
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2010-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
Sponsor:
Danish Pain Research Center
Organization:
Study Overview
Official Title:
Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
Status:
COMPLETED
Status Verified Date:
2012-03
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 purpose is to study the effect of spinal cord stimulation (SCS) on sensory parameters, using quantitative sensory testing (QST).
Patients with established SCS treatment will be examined with QST. Subjects will be randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same QST protocol.
After the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period.
The investigators expect to demonstrate that SCS treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.
Patients with established SCS treatment will be examined with QST. Subjects will be randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same QST protocol.
After the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period.
The investigators expect to demonstrate that SCS treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: