NCT04530214

Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Reaction

Interventions

Type	Name	Description
OTHER	Blood collection	Blood collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)
OTHER	Saliva collection	Saliva collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)
OTHER	Electrocardiography (ECG)	Electrocardiography (ECG) at enrollment (24-72h following surgery) and at Visit 1 (45-60 days following surgery) to assess heart rate variability
BEHAVIORAL	Questionnaires	Mental health assessment through questionnaires at enrollment (24-72h following surgery), at Visit 1 (45-60 days following surgery), at Visit 2 (7 months following surgery) and at Visit 3 (12 months following surgery)

Timeline

• Start date: 2020-11-04
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2020-08-28
• Last updated: 2023-04-28

Locations

4 sites across 1 country: France