Ignite Creation Date:
2024-05-06 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03371225
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2017-11-20
Brief Title:
Optimized tDCS for Fibromyalgia Targeting the Endogenous Pain Control System
Sponsor:
Spaulding Rehabilitation Hospital
Organization:
Spaulding Rehabilitation Hospital
Study Overview
Official Title:
Optimized tDCS for Fibromyalgia Targeting the Endogenous Pain Control System
Status:
RECRUITING
Status Verified Date:
2024-01
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:
This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation tDCS 16 tDCS sessions combined with exercise on pain control Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia FM Therefore the investigators designed a 2x2 factorial mechanistic trial tDCS active and sham and aerobic exercise AE active and control to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation CPM and central sensitization as assessed by temporal slow pain summation TSPS and compared to either intervention alone and to no intervention
Detailed Description:
Recent evidence has suggested that FM pain can be related to deficits in pain endogenous regulatory control and that novel non-pharmacological interventions such as tDCS can modulate this system and consequently reduce pain intensity Widespread pain in FM is thought to represent enhanced pain sensitivity that is maintained by central mechanisms This suggests changes in the descending pain control mechanisms and a possible relationship with the central sensitization phenomenon Recent evidence has suggested that pain inhibitory pathways are affected in FM thus further understanding these pathways role can significantly change how the treatment of this condition In this study the investigators will test the effects of two interventions -tDCS and aerobic exercise - on the modulation of the endogenous inhibitory pain system in fibromyalgia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None