Perception of Stressful Social Stimuli After Trauma Exposure.

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421587
• Other study ID #: TT-Study
• Status: Completed
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotion recognition ratings obtained during a forced-choice emotional face recognition task with stimuli of varying intensities (neutral to fearful).		Ratings will be assessed throughout fMRI scanning over the course of 25 minutes.
Primary	Neural substrates of social tactile stimuli processing.	fMRI scanning will be used to measure neural respones to tactile stimuli.	The neural substrates will be assessed througout fMRI scanning over the course of 20 minutes.
Primary	Valence ratings of social tactile stimuli.		Ratings will be assessed throughout fMRI scanning over the course of 20 minutes.
Primary	Neural substrates of social olfactory stimuli processing.		The neural substrates will be assessed througout fMRI scanning over the course of 25 minutes.
Secondary	Oxytocin plasma concentrations.		The oxytocin plasma concentrations of all participants will be assessed 15 minutes before fMRI scanning onset..
Secondary	Olfactory performance in a n-butanol odor staircase threshold test.	Participants' olfactory performance will be assessed by administering the 'Sniffin' Sticks' test, which measures nasal chemosensory performance based on pen-like odor dispensing devices.	The olfactory threshold of all participants will be assessed in a screening session at least 24 hours prior to fMRI scanning.

External Links

•   Link