Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

Traumatic Brain Injury Clinical Trial

Official title:

Hyperbaric Oxygen Therapy Treatment of Chronic Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

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
• 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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Post-Concussion Syndrome
• Syndrome
• Traumatic Brain Injury
• Wounds and Injuries

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

External Links

•   study website