Trial Outcomes & Findings for Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy (NCT NCT00810615)
NCT ID: NCT00810615
Last Updated: 2018-08-13
Results Overview
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The verbal memory score demonstrates improvement as the score increases. The score range was 36.8 to 98.6.
COMPLETED
PHASE1/PHASE2
50 participants
Baseline and six weeks post hyperbaric exposure series
2018-08-13
Participant Flow
Recruitment occurred from Nov 2008 - Nov 2010. Candidate subjects with a diagnosis of chronic truamatic brain injury (TBI) were identified by DoD neurologists. Those interested were screened for inclusion/exclusion criteria. 103 candidates were screened. 22 did not qualify; 31 were deferred (psychotropic medication or mental status unstable).
Participant milestones
| Measure |
Sham Treatment
Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment pressure. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) at the same frequency as if they were in the treatment exposure pressure.
|
Hyperbaric Oxygen 2.4 ATA
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations) during the exposure.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Sham Treatment
Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment pressure. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) at the same frequency as if they were in the treatment exposure pressure.
|
Hyperbaric Oxygen 2.4 ATA
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations) during the exposure.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy
Baseline characteristics by cohort
| Measure |
Total
n=50 Participants
Total of all reporting groups
|
Sham Treatment
n=25 Participants
Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment leg. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness)at the same frequency as if they were in the treatment exposure pressure.
|
Hyperbaric Oxygen 2.4 ATA
n=25 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations)during the exposure.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
28.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
28.3 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: one subject withdrawal from each group due to personal reasons
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The verbal memory score demonstrates improvement as the score increases. The score range was 36.8 to 98.6.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - ImPACT Verbal Memory
Baseline
|
70.48 units on a scale
Standard Deviation 13.05
|
74.21 units on a scale
Standard Deviation 12.03
|
—
|
—
|
|
Computer Cognitive Test Scores - ImPACT Verbal Memory
six weeks post hyperbaric exposure series
|
78.12 units on a scale
Standard Deviation 16.087
|
75.36 units on a scale
Standard Deviation 15.230
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline compared to the change at post hyperbaric exposures (30) series and the six weeks post hyperbaric exposure seriesPopulation: Per protocol. The study was a pilot.
The PCL-M is a self reported test in which a list of 17 problems and complaints are offered to the individual to score on a 1 to 5 scale with 1 designating "not at all", 2= "a little bit", 3= "moderately", 4= "quite a bit" and 5 designating "extremely". A sample complaint would be "repeated, disturbing dreams of a stressful military experience". Hence there is a possible total score range from 17 to 85. For military members, a score of 50 or above is indicative of PTSD. A change from baseline of 5-9 represents a reliable change and change of 10 or greater is a significant change.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores
Baseline measurement
|
48.88 units on a scale
Standard Deviation 12.59
|
50.38 units on a scale
Standard Deviation 14.53
|
—
|
—
|
|
Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores
Post 30 hyperbaric exposures
|
-10.125 units on a scale
Standard Deviation 10.759
|
-8.875 units on a scale
Standard Deviation 8.789
|
—
|
—
|
|
Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores
6 Week Follow-up
|
-8.292 units on a scale
Standard Deviation 10.960
|
-8.625 units on a scale
Standard Deviation 10.761
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesThe Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The visual memory score demonstrates improvement as the score increases. The score range was 31.2 to 92.7.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - ImPACT Visual Memory
Baseline
|
56.56 units on a scale
Standard Deviation 14.86
|
59.8 units on a scale
Standard Deviation 12.17
|
—
|
—
|
|
Computer Cognitive Test Scores - ImPACT Visual Memory
six weeks post hyperbaric exposure series
|
64.72 units on a scale
Standard Deviation 15.19
|
66.8 units on a scale
Standard Deviation 14.72
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: one subject withdrawal from each group due to personal reasons
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The Processing Speed score demonstrates improvement as the score increases. The score range was 9.7 to 52.4.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - ImPACT Processing Speed
Baseline
|
30.26 units on a scale
Standard Deviation 8.50
|
29.62 units on a scale
Standard Deviation 9.61
|
—
|
—
|
|
Computer Cognitive Test Scores - ImPACT Processing Speed
Six weeks post hyperbaric exposure series
|
36.71 units on a scale
Standard Deviation 10.47
|
33.84 units on a scale
Standard Deviation 10.30
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: one subject withdrawal from each group due to personal reasons
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The reaction time score demonstrates improvement as the score decreases. The score range was 0.42 to 1.84.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - ImPACT Reaction Time
Baseline
|
0.739 units on a scale
Standard Deviation 0.322
|
0.725 units on a scale
Standard Deviation 0.199
|
—
|
—
|
|
Computer Cognitive Test Scores - ImPACT Reaction Time
Six weeks post hyperbaric exposure series
|
0.677 units on a scale
Standard Deviation 0.186
|
0.712 units on a scale
Standard Deviation 0.266
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: One subject withdrawal from each group due to personal reasons
Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The simple reaction time range is 30 to 255.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - BrainCheckers Simple Reaction Time
Baseline
|
142.21 units on a scale
Standard Deviation 60.68
|
135.79 units on a scale
Standard Deviation 61.48
|
—
|
—
|
|
Computer Cognitive Test Scores - BrainCheckers Simple Reaction Time
Six weeks post hyperbaric exposure series
|
174.96 units on a scale
Standard Deviation 57.75
|
171.83 units on a scale
Standard Deviation 54.66
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: One subject withdrawal from each group due to personal reasons
Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 9 to 66. The scores in this section represent results of the code substitution subtest.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - BrainCheckers Code Substitution
Baeline
|
39.20 units on a scale
Standard Deviation 12.08
|
37.42 units on a scale
Standard Deviation 13.74
|
—
|
—
|
|
Computer Cognitive Test Scores - BrainCheckers Code Substitution
Post hyperbaric exposure 6 week follow up throughp
|
43.39 units on a scale
Standard Deviation 13.56
|
40.71 units on a scale
Standard Deviation 12.10
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: One subject withdrawal from each group due to personal reasons
Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 25 to 118. The scores in this section represent results of the procedural reaction time.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - BrainCheckers Procedural Reaction Time
Baseline
|
81.63 units on a scale
Standard Deviation 20.82
|
81.17 units on a scale
Standard Deviation 21.66
|
—
|
—
|
|
Computer Cognitive Test Scores - BrainCheckers Procedural Reaction Time
Post hyperbaric exposure 6 week follow up throughp
|
85.78 units on a scale
Standard Deviation 23.16
|
86.78 units on a scale
Standard Deviation 16.63
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: One subject withdrawal from each group due to personal reasons
Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 41 to 174. The scores in this section represent results of the Go-NoGo reaction time subtest.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - BrainCheckers Go-NoGo Reaction Time
Baseline
|
119.67 units on a scale
Standard Deviation 31.03
|
116.52 units on a scale
Standard Deviation 23.33
|
—
|
—
|
|
Computer Cognitive Test Scores - BrainCheckers Go-NoGo Reaction Time
Post hyperbaric exposure 6 week follow up throughp
|
131.70 units on a scale
Standard Deviation 31.43
|
129.17 units on a scale
Standard Deviation 25.67
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: One subject withdrawal from each group due to personal reasons
BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 50. The scores in this section represent results of the matching to sample subtest.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - BrainCheckers Matching To Sample
Baseline
|
20.00 units on a scale
Standard Deviation 10.70
|
23.71 units on a scale
Standard Deviation 11.86
|
—
|
—
|
|
Computer Cognitive Test Scores - BrainCheckers Matching To Sample
Post hyperbaric exposure 6 week follow up throughp
|
28.22 units on a scale
Standard Deviation 10.63
|
24.42 units on a scale
Standard Deviation 8.08
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and six weeks post hyperbaric exposure seriesPopulation: One subject withdrawal from each group due to personal reasons
BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 135. The scores in this section represent results of the code sub recall subtest.
Outcome measures
| Measure |
Sham Treatment
n=24 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=24 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
Computer Cognitive Test Scores - BrainCheckers Code Sub Recall
Post hyperbaric exposure 6 week follow up throughp
|
47.57 units on a scale
Standard Deviation 24.02
|
44.08 units on a scale
Standard Deviation 12.07
|
—
|
—
|
|
Computer Cognitive Test Scores - BrainCheckers Code Sub Recall
Baseline
|
29.88 units on a scale
Standard Deviation 16.63
|
36.38 units on a scale
Standard Deviation 19.77
|
—
|
—
|
SECONDARY outcome
Timeframe: six weeks post hyperbaric exposure seriesOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: six weeks post hyperbaric exposure seriesA non-parametric regression 14 using the Theil estimator was fit to the observed data in order to demonstrate general trends for relations between measures of cognitive functioning and increased stem cells.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Baseline values compared to 30 post hyperbaric exposure or 6 week follow-upPopulation: Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.
The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in the individuals who experienced only one concussive event.
Outcome measures
| Measure |
Sham Treatment
n=15 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=9 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
n=13 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
n=11 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Only One Concussive Event
|
4 participants
|
2 participants
|
4 participants
|
7 participants
|
POST_HOC outcome
Timeframe: Baseline values compared to 30 post hyperbaric exposure or 6 week follow-upPopulation: Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.
The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced two concussive events.
Outcome measures
| Measure |
Sham Treatment
n=15 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=9 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
n=13 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
n=11 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Two Concussive Events
|
6 participants
|
5 participants
|
3 participants
|
2 participants
|
POST_HOC outcome
Timeframe: Baseline values compared to 30 post hyperbaric exposure or 6 week follow-upPopulation: Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.
The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced three concussive events.
Outcome measures
| Measure |
Sham Treatment
n=15 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=9 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
n=13 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
n=11 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Three Concussive Events
|
3 participants
|
2 participants
|
4 participants
|
2 participants
|
POST_HOC outcome
Timeframe: Baseline values compared to 30 post hyperbaric exposure or 6 week follow-upPopulation: Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.
The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced four or more concussive events.
Outcome measures
| Measure |
Sham Treatment
n=15 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=9 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
n=13 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
n=11 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Four or More Concussive Events
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
POST_HOC outcome
Timeframe: Baseline values compared to 30 post hyperbaric exposure or 6 week follow-upPopulation: Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion who had multiple blast and/or impact event that did not result in a concussion (asymptomatic), but had a flight or flight (danger response) experience.
The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated for the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. Many subjects had multiple blast and/or impact events without a concussion (asymptomatic), but had a flight or flight (danger response) experience. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced multiple non-concussive blast and/or impact events.
Outcome measures
| Measure |
Sham Treatment
n=17 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=7 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
n=7 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
n=17 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Multiple Non-concussive Blast and/or Impact Exposures.
|
11 participants
|
5 participants
|
2 participants
|
9 participants
|
POST_HOC outcome
Timeframe: Baseline values compared to 30 post hyperbaric exposure or 6 week follow-upThe purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated for the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) with consent within one year from the last concussion in subjects who had multiple concussions.
Outcome measures
| Measure |
Sham Treatment
n=17 Participants
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Sham treatment
|
Hyperbaric Oxygen 2.4 ATA
n=7 Participants
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen @ 2.4 ATA: Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
|
Hyperbaric Oxygen 2.4 ATA Improved
n=17 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a significant (decrease by10 or greater)improvement or a reliable (decrease by 5 or greater) from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
Hyperbaric Oxygen 2.4 ATA Not Improved
n=7 Participants
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. See previous description for details.
PCL-M composite scores demonstrated a decrease of 4 or less from baseline at 30 post hyperbaric exposure or 6 week follow-up.
|
|---|---|---|---|---|
|
PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, Measuring Time to Consent From the Last Concussion in Subjects With Multiple Concussions.
|
1 participants
|
3 participants
|
3 participants
|
2 participants
|
Adverse Events
Sham Treatment
Hyperbaric Oxygen 2.4 ATA
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham Treatment
n=25 participants at risk
Subjects breathed air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 11 feet of sea water (fsw) or 1.3 ATA. The chamber pressure was slowly decreased over 10 minutes to 6 fsw (1.2 ATA). The final depressurization to surface was done over a 10 minute period. To simulate the treatment 2.4 ATA pressurization, pressurizations and depressurizations were done using venting techniques that would be nearly identical with the noise and temperature as that experienced with the treatment pressure. The inside observers simulated pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) at the same frequency as if they were in the treatment exposure pressure.
|
Hyperbaric Oxygen 2.4 ATA
n=25 participants at risk
Subject breathed 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures were done up to 5 times per week with a total number of 30 exposures. Pressurization time was seven minutes to a depth of 45 feet of sea water (fsw) or 2.4 ATA. The final depressurization to surface was done over a 10 minute period. Inside observers used pressure equalization measures (Valsalva) every 10 to 30 seconds and breathed oxygen by mask (required in the 2.4 ATA pressure to prevent decompression sickness) three times (10/15/5 minute durations) during the exposure.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear block
|
16.0%
4/25 • Number of events 8
|
40.0%
10/25 • Number of events 44
|
Additional Information
Dr. George Wolf, Associate Investigator
San Antonio Military Medical Center, Wilford Hall Ambulatory Surgical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place