Auvergne-Rhône-Alpes Regional Center for Psychotrauma
Lyon, 69003, France
Location contact
VIGNAUD Philippe, MD, PhD
CONTACT
VIGNAUD Philippe, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06494306
The core symptoms of post-traumatic stress disorder (PTSD) include flash backs, intrusive pictures and thoughts related to the traumatic event, hyperalertness, avoidance of traumatic relevant environmental triggers and emotional dysregulation. Some studies suggest that PTSD is also associated with impaired olfactory perception, which seems quite intuitive regarding the close anatomical-functional connections between olfactory and emotional circuits. Furthermore, some studies reported that olfactory stimuli can trigger flashbacks in subjects with PTSD. However, up to know available data is scarce and heterogeneous concerning that topic. The goal of the study is to determine the olfactory phenotype of subjects with PTSD. More precisely, this project aims at filling the above mentioned gap by systematically assessing the olfactory perception of subjects with PTSD along five dimensions: olfactory identity, hedonic value, familiarity, desirability and edibility. As a secondary goal, the relative weight of olfaction compared to the other senses in the relived memories of subjects with PTSD will be assessed.
The investigators here hypothesize a global impairment in olfactory processing (intensity, hedonicity, familiarity and edibility judgments) in PTSD subjects, compared with healthy subjects.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Observational
Lyon, 69003, France
VIGNAUD Philippe, MD, PhD
CONTACT
VIGNAUD Philippe, MD, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Investigators will collect the ETOC score in patient of both arms
To smell 20 odorant solutions and for each odor and evaluate it along five dimensions: familiarity, hedonicity, edibility, desire to smell again, perceived intensity). Each dimension is assessed with a Likert scale (from 1 (not at all) to 9 (extremely))
Patients with PTSD will have the following questionnaires : PTSD Checklist for Diagnostic and Statistical Manual (DSM)-V (PCL-5), Peri-trauma Dissociation Experience Questionnaire (PDEQ), Patient Health Questionnaire-9 (PHQ9), Snaith-Hamilton Pleasure Scale (SHAPS), Childhood Trauma Questionnaire (CTQ) and Apathy Evaluation Scale (AES)
Patients with PTSD will have Odor / trauma association questionnaire
Time frame: at inclusion
Results obtained in patients will be compared to those obtained in control group
Time frame: at inclusion
Analysis of covariance (ANCOVA) to determine the effect of different moderators (age, gender, type of trauma, time elapsed since trauma, type of treatment received, symptom intensity) on olfactory perception
Time frame: at inclusion
Sensory impressions: Nature and frequency of sensory descriptions associated with odor-evoked memories
Time frame: at inclusion
Language analysis: Use of Natural Language Processing (NLP) techniques to assess the emotional valence of odor-evoked memories and recurrent themes in oral responses concerning evoked memories. Analysis of the association of trauma-related odors with the 5 senses
Contact information is provided by the study sponsor or research team.
GALIA Perrine, CRA
CONTACT
VIGNAUD Philippe, MD, PhD
CONTACT
Hospices Civils de Lyon
Other
Acronym: TRAUMODO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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