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Traumatic Brain InjuryReBlastNCT05183087

Long-Term Effects of Repetitive, Low-Level Blast Exposure on Special Operations Forces Service Members

An observational study of Traumatic Brain Injury and Blast Injuries, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot study to identify biomarkers that individually, and in combination, demonstrate the greatest sensitivity to repetitive, low-level blast exposure (RLLBE) neurotrauma in Special Operations Forces (SOF) personnel. Read more about this study

Who is it for?
Ages 25 to 45 years, men only
Conditions the study is for
Traumatic Brain Injury, Blast Injuries
What is being tested?
3T Connectome MRI, 7 Tesla MRI and TSPO PET
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Jul 2021to 28 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • Men only
  • No healthy volunteers
  • Adult

Study population: U.S. Special Operations Forces personnel

Who may be able to join

  • Adults aged 25-45 years of age
  • Males, regardless of race or ethnicity
  • Active duty Special Operation Forces
  • History of combat deployment confirmed by Veterans Affairs (VA) or Department of Defense (DOD) records (defined as: while serving in the U.S. military, individual was deployed to a region of conflict)
  • History of combat exposure during any deployment as measured by endorsement of any item on the Combat Exposure Scale (CES)

Who cannot join

  • History of moderate or severe traumatic brain injury (TBI) (using the VA/DOD definition: initial Glasgow Coma Scale score < 13, coma duration > ½ hr, post-traumatic amnesia duration > 24 hr, or abnormal structural brain imaging)
  • History of major neurologic disorder such as stroke or spinal cord injury resulting in a significant decrement in functional status or loss of independent living capacity
  • Untreated or unstable severe psychiatric condition (e.g., schizophrenia or bipolar disorder) that is likely to impact study participation or ability to complete study procedures
  • Current severe medical condition (excluding currently diagnosed mild TBI or concussion) that requires long-term treatments (e.g., cancer, diabetes mellitus, human immunodeficiency virus, autoimmune disorders)
  • Any cardiac, respiratory, or other medical condition that may affect cerebral metabolism
  • Benzodiazepines other than lorazepam, desmethyldiazepam and oxazepam within past month
Show all 14Show fewer
  • MRI contraindications
  • Metal in the body that would make an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye
  • Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
  • Inability to lie supine for up to 2 hours in the MRI scanner, as assessed by physical examination and medical history (e.g., back pain, arthritis)
  • > 300 lbs (weight limit of the MRI table)
  • Prior radiation exposure of ≥ 50 mSv over the past 12 months, in the context of research, as determined by review of DOD medical records (e.g., prior imaging studies) and self-report
  • Any condition which, in the opinion of the Principal Investigator, may cause undue risk to the subject
  • Other: Any condition or characteristic that in the judgment of the Principal Investigator would create a logistical or safety contraindication to enrollment (e.g., shoulder width greater than the bore of the MRI or PET/MRI machines)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Pilot Study of Long-Term Effects of Repetitive, Low-Level Blast Exposure (RLLBE) on Special Operations Forces (SOF) Service Members

This is a pilot study to identify biomarkers that individually, and in combination, demonstrate the greatest sensitivity to repetitive, low-level blast exposure (RLLBE) neurotrauma in Special Operations Forces (SOF) personnel. The proposed cross-sectional, multimodal study will elucidate the potential effects of long-term RLLBE by comparing biomarkers across subjects.

Read the detailed description

The proposal includes a comprehensive battery of assessments characterized by high-field neuroimaging, proteomics, and experimental cognitive and neurobehavioral evaluations, which will be implemented alongside standardized clinical diagnostic tools. The results will inform the design of a larger trial to validate the diagnostic utility of these biomarkers as well as their ability to predict RLLBE-related clinical outcomes. A secondary aim will be to define the underlying mechanisms, risk and resilience factors, and clinical phenotypes associated with RLLBE.

Biomarkers assessed over the course of a two-day evaluation will include:

  1. 3 Tesla Connectome MRI to detect structural disruption of brain networks
  2. 7 Tesla MRI to detect functional disruption of brain networks
  3. Translocator protein (TSPO) PET - ligand [11C]-PBR28 to detect neuroinflammation
  4. Tau PET - ligand [18F]-MK6240 to detect tau deposition
  5. Neurocognitive assessments to detect signs of cognitive/behavioral dysfunction
  6. Self-report indicators of cognitive/behavioral dysfunction
  7. Blood biomarkers to detect evidence of blast injury using proteomics and metabolomics

We hypothesize that a multimodal assessment using Connectome MRI, 7 Tesla MRI, TSPO PET, Tau PET, cognitive/behavioral tests, proteomics and metabolomics will identify biomarkers of RLLBE-related brain injury.

Being tested
3T Connectome MRI, 7 Tesla MRI, TSPO PET, Tau PET, Cognitive and Behavioral Assessments
Medical subject headings
Brain Injuries, Traumatic, Blast Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3T Connectome MRIDiagnostic test

    MRI scan of structural connectivity

  • 7 Tesla MRIDiagnostic test

    MRI scan of functional connectivity

  • TSPO PETDiagnostic test

    PET scan of neuroinflammation

  • Tau PETDiagnostic test

    PET scan of tau deposition

  • Cognitive and Behavioral AssessmentsDiagnostic test

    Assessments of memory, attention, complex reasoning, mood and other cognitive/behavioral domains

  • Blood BiomarkersDiagnostic test

    Blood-based assessments of proteomic and metabolic biomarkers of brain injury

Study groups in NCT05183087
Study groupRoleWhat they receive
Special Operations Forces (SOF) Personneln=30 SOF Personnel
Receives: Diagnostic Test: 3T Connectome MRI; Diagnostic Test: 7 Tesla MRI; Diagnostic Test: TSPO PET; Diagnostic Test: Tau PET; Diagnostic Test: Cognitive and Behavioral Assessments; Diagnostic Test: Blood Biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diffusion MRI structural connectivity

    measured by white matter tractography

    Measured: Day 1

  2. fMRI resting state functional connectivity

    measured by default mode network connectivity

    Measured: Day 2

  3. PET Neuroinflammation

    measured by standardized uptake value ratio of TSPO ligand [11C]PBR28

    Measured: Day 1

  4. PET Tau deposition

    measured by standardized uptake value ratio of [18F]MK6240

    Measured: Day 2

  5. Neurofilament Light Chain

    measured by serum concentration of neurofilament light chain

    Measured: Day 1, after 6-8 hour fasting

  6. Cognitive Function

    measured by the Trail Making Test

    Measured: Day 1

  7. Behavioral symptoms

    measured by the Neurobehavioral Symptom Inventory

    Measured: Day 2

  8. Physical symptoms

    measured by the Neurobehavioral Symptom Inventory

    Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start1 Jul 2021
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05183087
Sponsor's protocol ID
2020P002695
Acronym
ReBlast
Status last verified
Apr 2023
First submitted
9 Dec 2021
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury and Blast Injuries, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diffusion MRI structural connectivity (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05183087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.

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