Stress, Psychological Clinical Trial
Official title:
Neurological and Psychological Effects of Combat-Related Stress
Verified date | April 2024 |
Source | Tel Aviv University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | March 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Tel Aviv University | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel Aviv University | Medical Corps, Israel Defense Force |
Israel,
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 |
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