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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02089594
Other study ID # LSU IRB #7381
Secondary ID W81XWH-10-1-0962
Status Recruiting
Phase Phase 3
First received March 14, 2014
Last updated April 16, 2017
Start date May 2014
Est. completion date March 2019

Study information

Verified date April 2017
Source Louisiana State University Health Sciences Center in New Orleans
Contact Cara J Rowe, MSW
Phone 504-427-5632
Email cjoh26@lsuhsc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).


Description:

This is a randomized prospective controlled single-blind crossover clinical trial of 1.5 ATA (atmospheres absolute) HBOT versus maintenance medication and counseling. One hundred adult subjects (50 at Louisiana State University Health Sciences Center-New Orleans and 50 at Oklahoma State University School of Medicine) with mTBI/PPCS who have been symptomatic continuously for at least six months from one or more mild traumatic brain injuries will be enrolled and randomized to either 40 HBOTs or no treatment. After the 8-week treatment period the no treatment group will be crossed over to receive 40 HBOTs.


Recruitment information / eligibility

Status Recruiting
Enrollment 59
Est. completion date March 2019
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Adults, 18-65 years old.

2. One or more mild TBI's due to blunt or blast injury.

3. Meets criteria for PPCS.

4. Ability to complete the NSI.

5. Ability to complete the PCL-M or C.

6. Ability to complete CAPS if needed.

7. Absence of acute cardiac arrest or hemorrhagic shock at time of TBI that would cause a global ischemic insult to the TBI.

8. Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug Abuse Screening Test (DAST).

9. Ability to complete a urine toxicology screen for drugs of abuse.

10. Negative pregnancy test in females. Female subjects will need to have a negative urinalysis result in order to start or continue treatment.

11. Subjects must be legally responsible, speak and understand English fluently, and be able to sign their own consent documents.

12. Otherwise good health.

Exclusion Criteria:

1. Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication, bullous emphysema).

2. Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).

3. Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation for MRI).

4. Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerative diseases, multiple sclerosis, congenital neurological disorder.

5. Participation in another experimental trial with active intervention.

6. High probability of inability to complete the experimental protocol (e.g. terminal condition or inability to complete outcome instruments).

7. Previous HBOT.

8. History of hospitalization for past stroke, non-febrile seizures, or any seizure history other than seizure at the time of TBI.

9. Past or current history of mental retardation.

10. Pre-/post-TBI history of systemic illness with impact on central nervous system (P.I.'s decision).

11. Pre-injury psychiatric disorders for which the patient was on medication at the time of the brain injury responsible for the patient's diagnosis of TBI/PPCS.

12. Any concurrent systemic illness whose symptomatology confounds the diagnosis of PPCS (P.I.'s decision).

13. Active malignancy undergoing treatment.

14. Taking lithium.

Study Design


Intervention

Drug:
Hyperbaric Oxygen
HBOT Group: Pressurization will proceed with 100% oxygen at 1.0 pounds per square inch (psi) per minute, the minimal pressurization rate, to 1.5 ATA (atmospheres absolute) or 7.35 psi and will take approximately 7 minutes. Pressurization will then resume until the final depth of 1.5 ATA is achieved. The patient will remain at depth for approximately 45 minutes and the subject will be informed of the onset of depressurization, which will occur at the same rate as pressurization. Total dive time will be 60 minutes.
No Hyperbaric Oxygen
Subjects will receive their usual care during the equivalent eight-week HBOT treatment period. There will be no hyperbaric chamber experience. At the conclusion of the eight-week control period both control and experimental subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group.

Locations

Country Name City State
United States Louisiana State University Health Sciences Center-New Orleans New Orleans Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Louisiana State University Health Sciences Center in New Orleans U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Working Memory One week after final HBOT
Primary Neurobehavioral Symptom Inventory (NSI) One week after final HBOT
Secondary Wechsler Abbreviated Scale of Intelligence II (WASI-II) 2 months after final HBOT
Secondary Wechsler Memory Scale-IV (WMS-IV 2 months after final HBOT
Secondary Rey Auditory Verbal Learning Test (RAVLT) 2 months after final HBOT
Secondary Benton Visual Retention Test with Alternate Forms (Benton VRT) 2 months after final HBOT
Secondary Stroop Color-Word Interference Test 2 months after final HBOT
Secondary Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS) 2 months after final HBOT
Secondary Category Fluency Test (Animal) 2 months after final HBOT
Secondary Automated Neuropsychological Assessment Metrics-4 (ANAM-4) 2 months after final HBOT
Secondary Pittsburgh Sleep Quality Index (PSQI) 2 months after final HBOT
Secondary Quality of Life After Brain Injury (QOLIBRI) 2 months after final HBOT
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