Clinical trial NCT03421587: Perception of Stressful Social Stimuli After Trauma Exposure.
Official title: Abnormal Processing of Stressful Social Stimuli After Trauma Exposure, in Particular After Childhood Maltreatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-traumatic Stress Disorder
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of trauma-exposed subjects and healthy controls without trauma-exposure.Patients and healthy controls will be recruited from the Bonn area.

Brief summary: Post-traumatic stress disorder is associated with altered processing of sensory stimuli. The clinical phenotype PTSD has predominantly been described for the visual and auditory sensory modalities. However, PTSD symptoms such as intrusive memories are often evoked by olfactory and tactile cues in the environment. Moreover, little is known about whether aberrant responses to social olfactory and tactile stimuli are also present in a subclinical population.The purpose of this study is to compare trauma-exposed subjects (e.g. childhood maltreatment) with non-exposed controls in the processing of olfactory and tactile stimuli. This sensory characterizations hold potential to identify potential biomarkers for the course of trauma-related disorders and to inform trauma therapies focusing on sensory integration.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Subjects that have experienced a traumatic event that meets the DSM-5 criteria

Exclusion Criteria:

* Schizophrenia, schizoaffective or other psychotic disorder
* Neurological disorders
* Psychotropic medication
* Subjects suffering from a respiratory tract infection or other respiratory disorder known to affect olfactory functioning at investigator's discretion
* Subjects with anosmia or other previous primary olfactory dysfunction (olfactory threshold score using the "Sniffin' Sticks" ≤ 5)
* Dermatitis of the extremities or other skin disorders that affect the skin sensitivity of the extremities

Primary outcomes:
measure: Emotion recognition ratings obtained during a forced-choice emotional face recognition task with stimuli of varying intensities (neutral to fearful).
timeFrame: Ratings will be assessed throughout fMRI scanning over the course of 25 minutes.
measure: Neural substrates of social tactile stimuli processing.
timeFrame: The neural substrates will be assessed througout fMRI scanning over the course of 20 minutes.
measure: Valence ratings of social tactile stimuli.
timeFrame: Ratings will be assessed throughout fMRI scanning over the course of 20 minutes.
measure: Neural substrates of social olfactory stimuli processing.
timeFrame: The neural substrates will be assessed througout fMRI scanning over the course of 25 minutes.
Secondary outcomes:
measure: Oxytocin plasma concentrations.
timeFrame: The oxytocin plasma concentrations of all participants will be assessed 15 minutes before fMRI scanning onset..
measure: Olfactory performance in a n-butanol odor staircase threshold test.
timeFrame: The olfactory threshold of all participants will be assessed in a screening session at least 24 hours prior to fMRI scanning.
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
Study officials:
affiliation: Department of Psychiatry, University of Bonn, Germany
name: René Hurlemann, PhD, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: