LIFT-UP: Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress
Study Details
Study Description
Brief Summary
The neurobiological response to stress is an adaptive response allowing us to cope with the multiple aggressions of daily life. This response orchestrates the body's systemic reaction. The intensity of response to stress can modify the body's functioning, which implies a variety of fields where biomarkers may be isolated: immunity, psychology, neurophysiology, integrative physiology. When stress is too intense or prolonged, response to stress may become misfitted and deleterious.
This study is based on the hypothesis that a severe physical or psychological trauma is associated with an intense and misfitted stress that is responsible from an undue immuno-inflammatory activation (through sympathetic activation). The result is a subinvasive state of systemic and tissue inflammation (low-noise inflammation), responsible for the mid-term deleterious consequences of the traumatic event.
The objective of this study is to understand how the dysregulation of intense stress simultaneously generates an initial pathological state and an alteration of mid-term evolution (which is considered as a poor prognosis and/or as responsible for after-effects).
The investigators wish to identify relevant biomarkers of the mechanisms activated during intense stress and influencing the immuno-inflammatory and epigenetic spheres with deleterious consequences on physiological and psychological functions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Occurrence of depression [12 months following surgery]
Screening for depression will be done using a validated self-report questionnaire, the Geriatric Depression Scale Short Version (GDS). We will use the threshold value of 10 (score > or =) which corresponds to a very high probability of depression.
- Occurrence of "psychosomatic death" [12 months following surgery]
The diagnosis of "psychosomatic death" will be made by a physician. There is no consensus on the diagnosis of this syndrome. However, a patient with "psychosomatic death" is likely to be hospitalized or followed up medically and will not be able to respond to the investigator's request for a telephone interview.
- Occurrence of death [12 months following surgery]
Vital status will be collected from the participant's family or referring physician or at the birth & death record service (of the participant's town)
Secondary Outcome Measures
- Evolution of heart rate variability between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Heart rate variability will be assessed using electrocardiography recordings
- Evolution of perceived stress level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Perceived stress level will be assessed with the Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
- Evolution of anxiety level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Anxiety level will be assessed with the French version of Spielberger's State-Trait Anxiety Inventory adapted for people aged 65 and older (IASTA-Y65+). Individual scores on the IASTA-Y 65+ can range from 20 to 80 with higher scores indicating higher anxiety.
- Evolution of post-traumatic stress disorder severity level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Post-traumatic stress disorder severity will be assessed with the Post-traumatic stress disorder CheckList for DSM-5 (Diagnostic and Statistical Manual Diploma in Social Medicine) (PCL-5) scale. Individual scores on the PCL-5 can range from 0 to 80 with higher scores indicating higher post-traumatic stress disorder severity.
- Evolution of quality of life between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Quality of life will be assessed using the abbreviated version of the World Health Organization Quality of Life (WHOQOL-Bref). The WHOQOL-Bref is grouped into 4 domains : Physical health (score range from 7 to 35) Psychological health (score range from 6 to 30) Social relationships (score range from 3 to 15) Environment (score range from 8-40) Higher scores indicate higher quality of life.
- Evolution of cortisol level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Cortisol level will be measured in saliva sample.
- Evolution of GABA level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Gamma-aminobutyric acid (GABA) level will be measured in blood sample.
- Evolution of oxydative stress level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Oxydative stress level will be measured in blood sample.
- Evolution of BDNF level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Brain-derived neurotrophic factor (BDNF) level will be measured in blood sample.
- Evolution of pro and anti-inflammatory cytokines level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Cytokines level will be measured in blood sample.
- Evolution of IGF-1 level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Insulin like growth factor type 1 (IGF-1) will be measured in blood sample.
- Evolution of NPY level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Neuropeptide Y (NPY) level will be measured in blood sample.
- Evolution of NPS between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Neutrophil-platelet score (NPS) will be measured in blood sample.
- Evolution of ocytocin level between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Ocytocin level will be measured in blood sample.
- Evolution of methylation of genes coding for BDNF between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Methylation of genes coding for BDNF will be measured on DNA extracted from blood sample.
- Evolution of methylation of genes coding for glucocorticoid receptors between enrollment and Visit 1 [Between enrollment and Visit 1 (45-60 days following surgery)]
Methylation of genes coding for glucocorticoid receptors will be measured on DNA extracted from blood sample.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Fracture of the upper end of the femur
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Cognitive state allowing the understanding of questionnaires
Exclusion Criteria:
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Traumatic Brain Injury
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Chronic inflammatory or immune pathologies
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On anticoagulants
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On neuroleptic or antidepressant treatment
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Pathology or health condition not allowing 1-year survival
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Pellegrin | Bordeaux | France | 33000 | |
| 2 | Hôpital d'Instruction des Armées Percy | Clamart | France | 92140 | |
| 3 | Hôpital d'Instruction des Armées Bégin | Saint-Mandé | France | 94163 | |
| 4 | Hôpital d'Instruction des Armées Sainte-Anne | Toulon | France | 83800 |
Sponsors and Collaborators
- Direction Centrale du Service de Santé des Armées
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018PPRC30
- 2019-A01811-56