Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI) (HOPPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01306968
First received: February 24, 2011
Last updated: August 25, 2014
Last verified: August 2014
Results First Received: July 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Post-concussive Symptoms
Traumatic Brain Injury
Interventions: Drug: hyperbaric oxygen
Other: sham hyperbaric air

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PTSD With no History of TBI Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
Standard TBI Care Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
HBO2 Group

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Sham Group

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.


Participant Flow:   Overall Study
    PTSD With no History of TBI     Standard TBI Care     HBO2 Group     Sham Group  
STARTED     7     23     24     25 [1]
COMPLETED     6     20     23     21  
NOT COMPLETED     1     3     1     4  
Lost to Follow-up                 1                 1                 0                 0  
Physician Decision                 0                 1                 0                 0  
Relocated and left active duty                 0                 1                 1                 1  
Withdrew - time commitment                 0                 0                 0                 2  
Withdrew over privacy concerns                 0                 0                 0                 1  
[1] 2 participants withdrew before chamber sessions were initiated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
PTSD With no History of TBI Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
Standard TBI Care Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
HBO2 Group

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Sham Group

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.

Total Total of all reporting groups

Baseline Measures
    PTSD With no History of TBI     Standard TBI Care     HBO2 Group     Sham Group     Total  
Number of Participants  
[units: participants]
  7     23     24     25     79  
Age  
[units: years]
Mean ± Standard Deviation
  33.0  ± 9.0     30.3  ± 7.2     32.5  ± 7.9     31.4  ± 7.6     31.6  ± 7.6  
Gender  
[units: participants]
         
Female     1     1     1     1     4  
Male     6     22     23     24     75  
Post-concussion Symptom Scores [1]
[units: units on a scale]
Mean ± Standard Deviation
         
RPQ-3     2.7  ± 1.89     5.4  ± 2.74     5.5  ± 3.27     4.7  ± 3.09     5.0  ± 3.01  
RPQ-13     20.9  ± 9.19     27.1  ± 12.20     27.5  ± 13.15     25.5  ± 11.61     26.2  ± 12.02  
RPQ Total     23.6  ± 10.11     32.5  ± 14.39     33.0  ± 15.82     30.2  ± 14.17     31.1  ± 14.55  
[1] The Rivermead Post-Concussion Symptom Questionnaire (RPQ) was created to measure the severity of post-concussion symptoms following traumatic brain injury (TBI). RPQ-3 are the first 3 symptoms of the RPQ Total including headaches, dizziness, and nausea/vomiting. RPQ-13 are the remaining 13 TBI symptoms. Using values of 0 (not experienced at all), 1 (no more of a problem than before the injury), 2 (mild problem), 3 (moderate problem), or 4 (severe problem). The range is 0 to 64. The score is a summation of symptoms rated as >2 representing new symptom onset or exacerbation of symptom(s).



  Outcome Measures
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1.  Primary:   Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat   [ Time Frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2 ]

2.  Primary:   Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat   [ Time Frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2 ]

3.  Primary:   Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population   [ Time Frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2 ]

4.  Primary:   Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population   [ Time Frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. R. Scott Miller, M.D.
Organization: Uniformed Services University of Health Sciences
phone: 301-816-8424
e-mail: robert.s.miller@us.army.mil


No publications provided


Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01306968     History of Changes
Other Study ID Numbers: S-10-09
Study First Received: February 24, 2011
Results First Received: July 16, 2014
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration