Neurological and Psychological Effects of Combat-Related Stress

Stress, Psychological Clinical Trial

Official title:

Neurological and Psychological Effects of Combat-Related Stress

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04651192
• Other study ID #: TAUatm
• Status: Active, not recruiting
• Start date: March 1, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine what is the neurological and cognitive impact of combat exposure and prolonged stress, in the form of service in the Israeli Defense Forces.

Description:

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. This study aimed to characterize the mental resilience of combat soldiers, and explore the neuro-cognitive impact of prolonged stress, using eye-tracking, MRI and fMRI measurements. Participants will be assessed using questionnaires, cognitive tasks and magnetic imaging at 5 timepoints over the span of 4 years. Outcome measures will be depression, anxiety and post-traumatic scores, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and blood oxygen level-dependent (BOLD) signals in magnetic resonance imaging (MRI) measurements.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Gender: Male
• Age group: 18 Years to 23 Years

Eligibility

Inclusion Criteria:

• Soldiers in the paratroopers brigade or students in Tel-Aviv University;

• A signed consent form;

• Hebrew native speakers.

Exclusion Criteria:

• A diagnosis of a neurological disorder (i.e., epilepsy, brain injury);

• Drug or alcohol abuse;

• Cannot undergo an MRI scan, due to metal implants or other metallic foreign bodies, claustrophobia, large tattoos or irremovable piercings;

• Require glasses with a number greater than 7;

• A diagnosis of psychotic or bipolar disorders.

Related Conditions & MeSH terms

• Stress Disorder, Posttraumatic
• Stress Disorders, Post-Traumatic
• Stress, Psychological

Intervention

Other:
• Combat Exposure
Soldiers will be exposed to combat as part of their routine military service. The ROTC students will not be exposed to combat.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel Aviv University	Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline - PTSD Checklist for DSM-5 (PCL-5) score	PCL is questionnaire assessing posttraumatic stress disorder symptoms. It contains 20 items on a severity scale of 0-4, measuring the existence and severity of post-traumatic symptoms. The minimal score, indicating no post-traumatic stress, is 0. The maximal score is 80, indicating extremely severe post-traumatic stress.	4 years, from time point 1 to time point 5
Primary	Neurological measures - Gray matter volume	Gray matter volume, i.e. the density of brain cells in a particular region (outcome to be measured in cm3), to be derived from the MRI scans, and compared between the two groups across the various time points.	4 years, from time point 1 to time point 5
Primary	Neurological measures - Functional connectivity	Functional connectivity, indicating the level of synchronous activity of certain brain regions during rest (temporal correlation is usually expressed as a Pearson's r); Also to be derived from the MRI scans, and compared between the two groups across the various time points.	4 years, from time point 1 to time point 5
Primary	Neurological measures - Structural connectivity	Structural connectivity between regions of the brain (Diffusivity is measured as 10-3mm2.s-1) and the properties of the white matter (expressed with Diffusion tensor imaging (DTI) measures, mainly Fractional Anisotropy (FA) and Mean Diffusivity (MD)); Also be derived from the MRI scans, and compared between the two groups across the various time points.	4 years, from time point 1 to time point 5
Primary	Neurological measures - Task activations	Task activations, and specifically the areas activated during the dot-probe task, and how they change over time (expressed as the level of the BOLD signal strength change during the task). To be derived from the MRI scans, and compared between the two groups across the various time points.	4 years, from time point 1 to time point 5