Trial Outcomes & Findings for Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI) (NCT NCT01306968)
NCT ID: NCT01306968
Last Updated: 2014-09-05
Results Overview
The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Results posted on
2014-09-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
23
|
24
|
25
|
|
Overall Study
COMPLETED
|
6
|
20
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Relocated and left active duty
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrew - time commitment
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrew over privacy concerns
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI)
Baseline characteristics by cohort
| Measure |
PTSD With no History of TBI
n=7 Participants
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
n=23 Participants
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
|
HBO2 Group
n=24 Participants
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
n=25 Participants
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
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
31.6 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Post-concussion Symptom Scores
RPQ-3
|
2.7 units on a scale
STANDARD_DEVIATION 1.89 • n=5 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 2.74 • n=7 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 3.27 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 3.09 • n=4 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 3.01 • n=21 Participants
|
|
Post-concussion Symptom Scores
RPQ-13
|
20.9 units on a scale
STANDARD_DEVIATION 9.19 • n=5 Participants
|
27.1 units on a scale
STANDARD_DEVIATION 12.20 • n=7 Participants
|
27.5 units on a scale
STANDARD_DEVIATION 13.15 • n=5 Participants
|
25.5 units on a scale
STANDARD_DEVIATION 11.61 • n=4 Participants
|
26.2 units on a scale
STANDARD_DEVIATION 12.02 • n=21 Participants
|
|
Post-concussion Symptom Scores
RPQ Total
|
23.6 units on a scale
STANDARD_DEVIATION 10.11 • n=5 Participants
|
32.5 units on a scale
STANDARD_DEVIATION 14.39 • n=7 Participants
|
33.0 units on a scale
STANDARD_DEVIATION 15.82 • n=5 Participants
|
30.2 units on a scale
STANDARD_DEVIATION 14.17 • n=4 Participants
|
31.1 units on a scale
STANDARD_DEVIATION 14.55 • n=21 Participants
|
PRIMARY outcome
Timeframe: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2Population: Intent to treat population: All randomized participants were included in the intention-to-treat analysis.
The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.
Outcome measures
| Measure |
PTSD With no History of TBI
n=6 Participants
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
n=20 Participants
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
|
HBO2 Group
n=23 Participants
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. 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
n=21 Participants
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.
|
|---|---|---|---|---|
|
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat
RPQ-3
|
3.5 units on a scale
Standard Deviation 3.21
|
5.1 units on a scale
Standard Deviation 2.81
|
4.2 units on a scale
Standard Deviation 3.00
|
3.5 units on a scale
Standard Deviation 3.25
|
|
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat
RPQ-13
|
19.7 units on a scale
Standard Deviation 13.06
|
25.5 units on a scale
Standard Deviation 13.93
|
22.5 units on a scale
Standard Deviation 12.35
|
20.7 units on a scale
Standard Deviation 12.82
|
|
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat
Total RPQ
|
23.2 units on a scale
Standard Deviation 16.04
|
30.6 units on a scale
Standard Deviation 16.08
|
26.7 units on a scale
Standard Deviation 24.83
|
24.2 units on a scale
Standard Deviation 15.38
|
PRIMARY outcome
Timeframe: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2Population: Intent to treat population: All randomized participants were included in the intention-to-treat analysis
Means for the change from baseline to follow-up visit 2
Outcome measures
| Measure |
PTSD With no History of TBI
n=6 Participants
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
n=20 Participants
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
|
HBO2 Group
n=23 Participants
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. 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
n=21 Participants
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.
|
|---|---|---|---|---|
|
Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat
RPQ-3
|
0.3 units on a scale
Standard Deviation 2.73
|
0.0 units on a scale
Standard Deviation 2.05 • Interval -0.96 to 0.96
|
-1.2 units on a scale
Standard Deviation 2.81 • Interval 0.0 to 2.43
|
-1.5 units on a scale
Standard Deviation 3.01 • Interval 0.11 to 2.85
|
|
Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat
RPQ-13
|
-3.0 units on a scale
Standard Deviation 15.39
|
-0.5 units on a scale
Standard Deviation 9.65 • Interval -4.0 to 5.0
|
-4.2 units on a scale
Standard Deviation 11.42 • Interval -0.8 to 9.1
|
-5.5 units on a scale
Standard Deviation 10.50 • Interval 0.7 to 10.3
|
|
Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat
Total RPQ
|
-2.7 units on a scale
Standard Deviation 17.88
|
-0.5 units on a scale
Standard Deviation 11.32 • Interval -4.8 to 5.8
|
-5.4 units on a scale
Standard Deviation 13.66 • Interval -0.5 to 11.3
|
-7.0 units on a scale
Standard Deviation 12.97 • Interval 1.0 to 12.9
|
PRIMARY outcome
Timeframe: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2Population: Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.
The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.
Outcome measures
| Measure |
PTSD With no History of TBI
n=6 Participants
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
n=20 Participants
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
|
HBO2 Group
n=11 Participants
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. 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
n=13 Participants
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.
|
|---|---|---|---|---|
|
Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population
RPQ-3
|
3.5 units on a scale
Standard Deviation 3.21
|
5.1 units on a scale
Standard Deviation 2.81
|
3.1 units on a scale
Standard Deviation 2.21
|
2.7 units on a scale
Standard Deviation 2.84
|
|
Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population
RPQ-13
|
19.7 units on a scale
Standard Deviation 13.06
|
25.5 units on a scale
Standard Deviation 13.93
|
15.6 units on a scale
Standard Deviation 10.93
|
17.4 units on a scale
Standard Deviation 13.25
|
|
Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population
Total RPQ
|
23.2 units on a scale
Standard Deviation 16.04
|
30.6 units on a scale
Standard Deviation 16.08
|
18.7 units on a scale
Standard Deviation 12.96
|
20.1 units on a scale
Standard Deviation 15.67
|
PRIMARY outcome
Timeframe: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2Population: Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.
The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.
Outcome measures
| Measure |
PTSD With no History of TBI
n=6 Participants
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
n=20 Participants
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
|
HBO2 Group
n=11 Participants
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. 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
n=13 Participants
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.
|
|---|---|---|---|---|
|
Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population
RPQ-3
|
0.3 units on a scale
Standard Deviation 2.73
|
0.0 units on a scale
Standard Deviation 2.05 • Interval 2.05 to
|
-1.6 units on a scale
Standard Deviation 2.54
|
-2.2 units on a scale
Standard Deviation 2.44
|
|
Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population
RPQ-13
|
-3.0 units on a scale
Standard Deviation 15.39
|
-0.5 units on a scale
Standard Deviation 9.65 • Interval -4.0 to 5.0
|
-9.4 units on a scale
Standard Deviation 9.68 • Interval 2.9 to 15.9
|
-8.5 units on a scale
Standard Deviation 9.44 • Interval 2.8 to 14.2
|
|
Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population
Total RPQ
|
-2.7 units on a scale
Standard Deviation 17.88
|
-0.5 units on a scale
Standard Deviation 11.32 • Interval -4.8 to 5.8
|
-11.0 units on a scale
Standard Deviation 11.64 • Interval 3.2 to 18.8
|
-10.7 units on a scale
Standard Deviation 11.22 • Interval 3.9 to 17.5
|
Adverse Events
PTSD With no History of TBI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard TBI Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HBO2 Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sham Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
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
n=24 participants at risk
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
n=23 participants at risk
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.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
mild ear pain
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
4.2%
1/24 • Number of events 1 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
4.3%
1/23 • Number of events 1 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
|
General disorders
Tooth pain
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
4.2%
1/24 • Number of events 1 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
0.00%
0/23 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
|
Ear and labyrinth disorders
Inner ear barotrauma
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
12.5%
3/24 • Number of events 3 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
0.00%
0/23 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
|
General disorders
Onset migraine headache
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
4.2%
1/24 • Number of events 1 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
0.00%
0/23 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
|
General disorders
Increase frequency and intensity of headaches
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
4.2%
1/24 • Number of events 1 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
0.00%
0/23 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
|
Eye disorders
Transient worsening of myopia
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
4.2%
1/24 • Number of events 1 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
0.00%
0/23 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
|
General disorders
Change in headache frequency
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
0.00%
0/24 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
4.3%
1/23 • Number of events 1 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
|
General disorders
Claustrophobia/anxiety
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
0.00%
0/24 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
4.3%
1/23 • Number of events 1 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
|
General disorders
Sinus pain
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
—
0/0 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
0.00%
0/24 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
13.0%
3/23 • Number of events 3 • Within 14 days of the last chamber session
Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
|
Additional Information
Dr. R. Scott Miller, M.D.
Uniformed Services University of Health Sciences
Phone: 301-816-8424
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place