Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT00760734
Eligibility Criteria:
Inclusion Criteria:
* Adults, 18-65 years old
* One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
* Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.
* Absence of intracranial neurosurgery post-TBI
* Disability Rating Scale of 0-3
* Negative Michigan Alcohol Screening Test (MAST)
* Negative Drug Abuse Screening Test (DAST)
* Negative urine toxicology screen for drugs of abuse
* Negative pregnancy test in females
* Otherwise good health
* Less than 90% on the Percent Back to Normal Rating Scale
Exclusion Criteria:
* Pulmonary disease that precludes HBOT
* Unstable medical conditions that are contraindicated in HBOT
* Severe confinement anxiety
* Pregnancy
* Other pre-TBI neurological diagnoses
* Pre or post TBI history of substance abuse
* Pre or post TBI history of alcoholism.
* Participation in another experimental trial with active intervention.
* High probability of inability to complete the experimental protocol.
* Previous HBOT
* History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI
* Past or current history of mental retardation (baseline FSIQ \< 71.
* Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00760734
Study Brief:
Protocol Section:
NCT00760734