Blast Overpressure Longitudinal Study

ConditionLow-level Blast Exposure

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-50

SponsorUniformed Services University of the Health Sciences

About this trial

The goal of this observational study is to learn about the impact of low-level blast exposure in U.S. Special Operations Forces personnel. The main questions it aims to answer are:

What advanced brain imaging changes are related to clinical presentation after low-level blast exposure? What are the relationships between low-level blast exposure and common groups of symptoms after concussion?

Participants will:

* Undergo advanced brain imaging * Answer questionnaires * Complete clinical tests * Provide blood, urine, and saliva samples * Wear blast sensors

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Active duty

U.S. SOF personnel

18-50 years old

Disqualifiers

Subjects will be excluded only if their participation will significantly interfere with validity of data collection or safety during the study (e.g., they have conditions that might result in harm or injury during research procedures).

Example: pregnancy (balance considerations)

Example: being unable to undergo MRI testing (i.e., they have non-MRI compatible devices, imbedded metal fragments such as shrapnel, and/or severe claustrophobia; these MRI contraindications will be screened using an MRI Safety Questionnaire)

Trial population

The target population is 250 SOF personnel, particularly those who are regularly exposed to occupational low-level blast exposure. Approximately 10% of the sample will be recruited as a control group of low/no exposure personnel.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants

are grouped into 2 trial groups

Group A: High exposure (experimental)

Group B: Low/No exposure (control)

Trial outcomes

Primary outcomes

Effective axonal radii mapping

The primary outcome measure in this study will be effective axonal radii (r\_eff) mapping derived from ultra-high performance diffusion magnetic resonance imaging using the MAGNUS system and its correlations to low-level blast exposure.

Time frame

At baseline and annually through study completion, an average of 5 years

Secondary outcomes

Ohio State University TBI Identification Method

The Ohio State University TBI Identification Method is a standardized approach for collecting an individual's comprehensive history of traumatic brain injuries through a structured interview lasting 3-5 minutes.

Time frame

At baseline and annually through study completion, an average of 5 years

Concussion Clinical Profiles Screening

The Concussion Clinical Profiles Screening (CP Screen) tool will be used to measure the five concussion clinical subtypes (profiles) and two modifiers. The CP Screen is a 29-item post-concussion symptom inventory. Subjects rate the severity of 29 symptoms on a scale from 0 (None \[Not experiencing this symptom.\]) to 3 (Severe). The CP Screen total score is a sum of the 29 items (range 0 to 87, higher scores mean a worse outcome). Subscale scores range from 0 to 15 for vestibular, ocular-motor, anxiety/mood, and post-traumatic headache (migraine); 0 to 9 for cognitive; 0 to 12 for sleep; and 0 to 6 for cervical spine.

Time frame

At baseline and annually through study completion, an average of 5 years

Neurobehavioral Symptom Inventory

The Neurobehavioral Symptom Inventory (NSI) is a 22-item post-concussion symptom inventory. The NSI total score is a sum of the 22 items (range 0 to 88, higher scores mean a worse outcome).

Time frame

At baseline and weekly through study completion, an average of 5 years

Headache Impact Test

The Headache Impact Test (HIT-6) is a 6-item assessment of the negative impact of headaches. The HIT-6 total score is a sum of the 6 items (range 36 to 78, higher scores mean a worse outcome).

Time frame

At baseline and weekly through study completion, an average of 5 years

Other outcomes

quantitative EEG via the NeuroCatch®

Cognition will be explored using quantitative EEG via the NeuroCatch® (NeuroCatch Inc., Canada) brain vital sign framework. This framework includes three event-related brain potentials (ERPs): auditory N100 (auditory sensation), auditory oddball P300 (basic attention), and auditory speech processing N400 (cognitive processing). NeuroCatch's multiple measurements will be aggregated to arrive at one reported value - normal or abnormal.

Time frame

At baseline and quarterly through study completion, an average of 5 years

Blast sensor-measurement of blast exposure(s)

Subjects will wear blast sensors continuously during training for the duration of their study participation. The blast sensors' multiple measurements will be aggregated to arrive at one reported value - total exposure (number of exposure events exceeding 4psi).

Time frame

Daily through study completion, an average of 5 years

Self-report of blast exposure(s)

Self-report of environment (i.e., indoor/outdoor, under overhang, etc.), role (shooter/breacher, observer, instructor), position (i.e., prone supported, prone unsupported, kneeling, standing, etc.), weapon (i.e., make/model, caliber, etc.), number of rounds, date/time, and duration of training will also be collected on training days. The questionnaire-based self-report of blast exposure(s) will be aggregated to arrive at one reported value - estimated total exposure (number of exposure events).

Time frame

Daily through study completion, an average of 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uniformed Services University of the Health Sciences

Lead sponsor

The Geneva Foundation

Collaborator

MIT Lincoln Laboratory

Collaborator

Source ClinicalTrials.gov

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