Phase
Condition
Neurologic Disorders
Traumatic Brain Injury
Brain Injury
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults, 18-65 years old.
One or more mild TBI's due to blunt or blast injury.
Meets criteria for PPCS.
Ability to complete the NSI.
Ability to complete the PCL-M or C.
Ability to complete CAPS if needed.
Absence of acute cardiac arrest or hemorrhagic shock at time of TBI that would cause aglobal ischemic insult to the TBI.
Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug AbuseScreening Test (DAST).
Ability to complete a urine toxicology screen for drugs of abuse.
Negative pregnancy test in females. Female subjects will need to have a negativeurinalysis result in order to start or continue treatment.
Subjects must be legally responsible, speak and understand English fluently, and beable to sign their own consent documents.
Otherwise good health.
Exclusion
Exclusion Criteria:
Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication,bullous emphysema).
Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestiveheart failure or heart failure requiring hospital emergency evaluation or admission inthe previous year).
Severe confinement anxiety (e.g., patients who require anesthesia conscious sedationfor MRI).
Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerativediseases, multiple sclerosis, congenital neurological disorder.
Participation in another experimental trial with active intervention.
High probability of inability to complete the experimental protocol (e.g. terminalcondition or inability to complete outcome instruments).
Previous HBOT.
History of hospitalization for past stroke, non-febrile seizures, or any seizurehistory other than seizure at the time of TBI.
Past or current history of mental retardation.
Pre-/post-TBI history of systemic illness with impact on central nervous system (P.I.'s decision).
Pre-injury psychiatric disorders for which the patient was on medication at the timeof the brain injury responsible for the patient's diagnosis of TBI/PPCS.
Any concurrent systemic illness whose symptomatology confounds the diagnosis of PPCS (P.I.'s decision).
Active malignancy undergoing treatment.
Taking lithium.
Study Design
Study Description
Connect with a study center
Louisiana State University Health Sciences Center-New Orleans
New Orleans, Louisiana 70112
United StatesActive - Recruiting

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