Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624581
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2020-11-05
Brief Title:
FIbromyalgia anD GenetIcs Subgroups FIDGIS
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome
Status:
COMPLETED
Status Verified Date:
2020-12
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:
FIDGIS
Brief Summary:
Fibromyalgia syndrome FS is characterized by widespread pain and affect 05 to 5 of the general population with a higher prevalence in women Recognized as disease by World Health Organization since 1992 FS concern 12 to 2 million of French people and his etiology need to be clarified This affection is characterized by a higher sensitivity to nociceptive stimulus articular and muscular pain and associated to fatigue headache sleep disorders depression and irritated bowel syndrome The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical physical social and psychologic conditions and of the therapeutic responses
Faced to the heterogeneity of FS various hypotheses about the development mechanisms exist Central sensitization could be one of the key mechanisms of FS it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms which results in permanent or chronic pain
Moreover work on the familial character of FS suggests that a genetic component may be involved in its development but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS
The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group matched in age sex and menopausal status
Faced to the heterogeneity of FS various hypotheses about the development mechanisms exist Central sensitization could be one of the key mechanisms of FS it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms which results in permanent or chronic pain
Moreover work on the familial character of FS suggests that a genetic component may be involved in its development but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS
The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group matched in age sex and menopausal status
Detailed Description:
This is an exploratory case control pathophysiology study of psychophysical central sensitization assessment and genetic candidate gene panel characteristics
The main objectives of this study are
Primary Evaluate the central nociception sensitization characteristics and genetic determinants in fibromyalgic syndrome comparing a group of patients to matched healthy controls
Secondary
1 Characterize genetic predispositions of central sensitization in patients with FS compared to matched healthy controls including confirmation of known genetic markers and potential identification of new genetic variants involved
2 Compare in the area of central sensitization the population of patients with FS and matched healthy controls
3 Compare in the domain of temporal summation the population of patients with FS and matched healthy controls
4 Describe in the clinical field the characteristics of the FS patient population
5 Compare in the areas of quality of life anxietydepression and comorbidities characteristics of the FS patient population and matched healthy controls
6 Compare epigenetic biomarkers of the FS patient population with healthy matched controls
7 Study of the role of the gut microbiota in patients with FS bio banking
8 Compare in the areas of pain sound and light sensitivity the population of patients with FS and matched healthy controls
The main objectives of this study are
Primary Evaluate the central nociception sensitization characteristics and genetic determinants in fibromyalgic syndrome comparing a group of patients to matched healthy controls
Secondary
1 Characterize genetic predispositions of central sensitization in patients with FS compared to matched healthy controls including confirmation of known genetic markers and potential identification of new genetic variants involved
2 Compare in the area of central sensitization the population of patients with FS and matched healthy controls
3 Compare in the domain of temporal summation the population of patients with FS and matched healthy controls
4 Describe in the clinical field the characteristics of the FS patient population
5 Compare in the areas of quality of life anxietydepression and comorbidities characteristics of the FS patient population and matched healthy controls
6 Compare epigenetic biomarkers of the FS patient population with healthy matched controls
7 Study of the role of the gut microbiota in patients with FS bio banking
8 Compare in the areas of pain sound and light sensitivity the population of patients with FS and matched healthy controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A01724-35 | OTHER | ANSM | None |