Blast Overpressure Longitudinal Study

NCT07606651 | Not Yet Recruiting

• 2 other identifiers: 25-21750HU00012520052
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Low-level Blast Exposure

Keywords

traumatic brain injury; concussion; magnetic resonance imaging; blast overpressure; low-level blast exposure; repeated blast exposure

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (32)

• Ohio State University TBI Identification Method

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

• Concussion Clinical Profiles Screening

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

• Neurobehavioral Symptom Inventory

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

• Headache Impact Test

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

• modified Military Concussion Readiness Inventory for Dizziness and Balance

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

Other Outcomes (3)

• quantitative EEG via the NeuroCatch®

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

• Blast sensor-measurement of blast exposure(s)

  Daily through study completion, an average of 5 years

• Self-report of blast exposure(s)

  Daily through study completion, an average of 5 years

Study Arms (2)

High exposure (experimental)

Special Operations Forces personnel with higher occupational blast overpressure exposure as measured by blast sensor(s)

Low/No exposure (control)

Special Operations Forces personnel with lower occupational blast overpressure exposure as measured by blast sensor(s)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Active duty
• U.S. SOF personnel
• years old

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• The Geneva Foundation: collaborator
• MIT Lincoln Laboratory: collaborator

Study Sites (3)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Fort Bragg

Fort Bragg, North Carolina, 28310, United States

Location

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood; saliva; urine

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Vincent B Ho, MD

  Uniformed Services University of the Health Sciences

  STUDY CHAIR

• Tony T Yuan, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony T Yuan, PhD

CONTACT

214-808-8971; tony.yuan@usuhs.edu

Carrie W Hoppes, PhD

CONTACT

571-212-4660; carrie.hoppes.ctr@usuhs.edu

Study Design

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

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 26, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)