Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01861574
Status:
COMPLETED
Last Update Posted:
2018-09-27
First Post:
2012-04-26
Brief Title:
Transcranial Magnetic Stimulation Effects on Pain Perception
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Transcranial Magnetic Stimulation TMS Effects on Pain Perception
Status:
COMPLETED
Status Verified Date:
2018-08
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:
TMS
Brief Summary:
The purpose of this research study is to investigate the effects of Transcranial Magnetic Stimulation on pain perception TMS is a non - invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people without the need for surgery anesthetic or other invasive procedures
Detailed Description:
To test whether rTMS over the left prefrontal cortex significantly reduces post-operative pain and PCA use following gastric-bypass surgery relative to sham and an active control in a mood- independent manner Note that the active control is still mentioned in the aims and hypotheses but was apparently removed from the study design
To determine the effects of timing one immediately following surgery and one 4 hours later and dose of TMS 0 1 or 2 sessions of active rTMS on post-operative pain and PCA use To determine the effects of TMS on post-surgical recovery time time to discharge and clinical outcomes at 1-month 3- months and 6-months follow-up Again an active control is mentioned though this was removed from the design It appears that this aspect of the proposal was not edited to reflect the new study design
In the new design 108 participants received two 20 minute sessions of 10 Hz rTMS 110 of motor threshold over the left dorsolateral prefrontal cortex one immediately following surgery and one 4 hours later Participants were randomly assigned to receive two sessions of real rTMS two sessions of sham 1 real then 1 sham or 1 sham then 1 real rTMS treatments
To determine the effects of timing one immediately following surgery and one 4 hours later and dose of TMS 0 1 or 2 sessions of active rTMS on post-operative pain and PCA use To determine the effects of TMS on post-surgical recovery time time to discharge and clinical outcomes at 1-month 3- months and 6-months follow-up Again an active control is mentioned though this was removed from the design It appears that this aspect of the proposal was not edited to reflect the new study design
In the new design 108 participants received two 20 minute sessions of 10 Hz rTMS 110 of motor threshold over the left dorsolateral prefrontal cortex one immediately following surgery and one 4 hours later Participants were randomly assigned to receive two sessions of real rTMS two sessions of sham 1 real then 1 sham or 1 sham then 1 real rTMS treatments
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