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

NCT04530214 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2023-04-28

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530214 on ClinicalTrials.gov