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OpenTrials
Completed

NCT Number: NCT03421587

Perception of Stressful Social Stimuli After Trauma Exposure.

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Processing of social olfactory and tactile stimuli

Behavioral

Processing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging.

Primary outcomes

  1. Emotion recognition ratings obtained during a forced-choice emotional face recognition task with stimuli of varying intensities (neutral to fearful).

    Time frame: Ratings will be assessed throughout fMRI scanning over the course of 25 minutes.

  2. Neural substrates of social tactile stimuli processing.

    Time frame: The neural substrates will be assessed througout fMRI scanning over the course of 20 minutes.

    fMRI scanning will be used to measure neural respones to tactile stimuli.

  3. Valence ratings of social tactile stimuli.

    Time frame: Ratings will be assessed throughout fMRI scanning over the course of 20 minutes.

  4. Neural substrates of social olfactory stimuli processing.

    Time frame: The neural substrates will be assessed througout fMRI scanning over the course of 25 minutes.

Secondary outcomes

  1. Oxytocin plasma concentrations.

    Time frame: The oxytocin plasma concentrations of all participants will be assessed 15 minutes before fMRI scanning onset..

  2. Olfactory performance in a n-butanol odor staircase threshold test.

    Time frame: The olfactory threshold of all participants will be assessed in a screening session at least 24 hours prior to fMRI scanning.

    Participants' olfactory performance will be assessed by administering the 'Sniffin' Sticks' test, which measures nasal chemosensory performance based on pen-like odor dispensing devices.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Abnormal Processing of Stressful Social Stimuli After Trauma Exposure, in Particular After Childhood Maltreatment.

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Feb 15, 2019

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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