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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-04

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood collection

Blood collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)

Intervention Type OTHER

Saliva collection

Saliva collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)

Intervention Type 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

Intervention Type OTHER

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Fracture of the upper end of the femur
* Cognitive state allowing the understanding of questionnaires

Exclusion Criteria

* Traumatic Brain Injury
* Chronic inflammatory or immune pathologies
* On anticoagulants
* On neuroleptic or antidepressant treatment
* Pathology or health condition not allowing 1-year survival

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No