Biological Markers for Post-Traumatic Stress Disorder

NCT05213858 | Unknown

• 1 other identifier: 178-21
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to evaluate the sensitivity and specificity of a combination of various objective biomarkers for the diagnosis of PTSD.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• correlation between CAPS score and mean heart rate variability

  the correlation between CAPS score and mean heart rate variability will be evaluated

  at baseline

Secondary Outcomes (3)

• correlation between CAPS score and fronto-limbic connectivity

  at baseline

• correlation between CAPS score and frontal activity

  at baseline

• correlation between CAPS score and depression score

  at baseline

Interventions

CAPS questionnaire DIAGNOSTIC_TEST

PTSD diagnosis and severity will be done using the CAPS-5 questionnaire.

Beck Depression Inventory DIAGNOSTIC_TEST

depression symptoms will be measured by the BDI-II. The BDI-II consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression.

The Fibromyalgia Impact Questionnaire DIAGNOSTIC_TEST

The FIQ was developed from information gathered from patient reports, functional status instruments and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue and well-being over the past week.

The Pittsburgh Sleep Quality Index DIAGNOSTIC_TEST

sleep patterns will be measured using the PSQI. This index assesses the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, the use of sleeping medications and daytime dysfunction over the last month. Items are rated using a 0 to 3 scale. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Depression, Anxiety and Stress Scale-21 items DIAGNOSTIC_TEST

The DASS-21 is a three-scale self-report questionnaire designed to measure the emotional state of depression, anxiety and stress. Each scale contains 7 items, divided into subscales with similar content. Scores range between 0 and 21 in each subcategory.

Traumatic Events Questionnaire DIAGNOSTIC_TEST

The TEQ examines experiences of traumatic events (e.g. sexual abuse, accidents and crime) that are considered potential triggers of PTSD symptoms. To assess trauma intensity, respondents provide information for each event that was experienced, as well as their age at the time of the event. The items are measured on a 9-point Likert scale from "not at all" to "severely/extremely". The TEQ has previously been used in Israel.

Clinician Administered Dissociative States Scale DIAGNOSTIC_TEST

The CADSS is a 28-item structured clinical interview to assess state dissociation.

A diary will be used for seven consecutive nights DIAGNOSTIC_TEST

A diary will be used for seven consecutive nights for the evaluation of: * Mean sleep latency * The number and duration of awakenings. * Subjective total sleep time * Subjective wake after sleep onset * Sleep efficiency

MRI DIAGNOSTIC_TEST

Brain imaging will include DTI and resting state for structural and functional MRI scanning. Images will be acquired on MAGNETOM Vida 3T Scanner, configured with 64-channel receiver head coils (Siemens Healthcare, Erlangen, Germany) at the Department of Radiology at Shamir Medical Center.

Functional brain imaging DIAGNOSTIC_TEST

Functional magnetic resonance imaging (fMRI) is widely used to study the operational organization of the human brain. This technology measures brain activity by detecting changes associated with blood oxygenation, using blood-oxygen-level-dependent imaging (BOLD) contrast.

EEG analysis DIAGNOSTIC_TEST

EEG will be obtained using a point-of care device that consists of an EEG-Sense Headset, EEG-Sense Single-Use brush sensors, a pneumatic sensor positioning mechanism, EEG sampling electronics and software. The EEG-Sense Headset is an EEG electrode positioning system that quickly places electrodes in a uniform and consistent manner, to transfer electrophysiological EEG signals from an individual to a suitable EEG data collection device. The device is nonsterile, non-invasive and non-radiation emitting, and was developed for use in healthcare facilities and hospitals. Typical set-up and procedure time is several minutes. The device does not contain biologics, drugs, coatings or any claim of sterility. The EEG-Sense Single-Use brush sensors are made from well-established medical-grade materials; the Headset is made from Nylon 101. Electronic components and harnesses are embedded between two layers of nylon and are attached to each electrode port.

Autonomic nervous system monitors DIAGNOSTIC_TEST

Data will be collected using Empatica's E4 wristband. Each of the study participants will wear the wristband for 7 days. Data collected from the band will include: ACC - Data from 3-axis accelerometer sensor in the range \[-2g, 2g\]. (sampled at 32 Hz) BVP - Data from photoplethysmography (PPG). (sampled at 64 Hz) EDA - Data from the electrodermal activity sensor in μS. (sampled at 4 Hz) IBI - Inter-beat intervals. (intermittent output with 1/64 second resolution) TEMP - Data from temperature sensors, expressed in degrees on the Celsius (°C) scale. (sampled at 4 Hz)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Male combatants aged 20-60 years, with a history of exposure to an apparently life threatening-combat event, with or without PTSD.

You may qualify if:

• The willingness and ability to read, understand and sign an informed consent form.
• Age 20-60 years.
• A history of more than 2 years of combat service, and of at least one potentially life-threatening combat experience.
• One year or more after the last combat experience.

You may not qualify if:

• Inability to attend scheduled clinic visits or comply with the study protocol
• A history of traumatic brain injury or any other known brain pathology.
• Substance use, except for prescribed cannabis, if it can be withheld for at least 24 hours prior to the study evaluation.
• A current psychiatric disorder other than PTSD.
• The inability to perform an awake brain MRI.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf-Harofeh Medical Center

Ramla, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Functional Neuroimaging

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• keren doenyas-barak, md

  sagol center for hyperbaric medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

keren doenyas-barak, MD

CONTACT

+972544215487; kerendoenyas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: January 28, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-01

Locations

IL (1)