Trial · NCT01611194

mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms

NCT01611194, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2018-11-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms. Trials, record NCT01611194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01611194

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms
NCT number: NCT01611194
Status: Completed
Phases: Phase 2
Enrollment: 71 participants, actual
Lead sponsor: U.S. Army Medical Research and Development Command
Conditions: Traumatic Brain Injury With Brief Loss of Consciousness, Post-Concussion Syndrome
Interventions: Hyperbaric oxygen (HBO2) at 1.5 atms, Sham control 1.2 atms
First posted: 2012-06-04
Last updated: 2018-11-21
Results first posted: 2018-11-21

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Summary of Treatment-Emergent Adverse Events	months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months	Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.
Primary	Summary of Study Intervention-Related Adverse Events	months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months	Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.
Secondary	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population)	Baseline	RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. 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 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. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain.
Secondary	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population)	Baseline	RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. 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 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. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain.
Secondary	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population)	Baseline to week 13, Months 6 and 12	RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. 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 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. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. The scores were derived by totaling the corresponding question scores for each domain and it's change from baseline.
Secondary	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population)	Baseline to week 13, Months 6 and 12	RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. 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 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. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and it's change from baseline.
Secondary	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population)	Baseline to week 13, Months 6 and 12	RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. 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 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. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Secondary	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population)	Baseline to week 13, Months 6 and 12	RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. 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 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. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Secondary	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population)	Baseline to week 13, Months 6 and 12	RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. 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 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. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ-3total scale, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Secondary	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population)	Baseline to week 13, Months 6 and 12	RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. 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 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. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. The scores were derived by totaling the corresponding question scores for each domain and change from baseline.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Summary of Treatment-Emergent Adverse Events	months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Summary of Study Intervention-Related Adverse Events	months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population)	Baseline		RPQ scores	MEAN
SECONDARY	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population)	Baseline	PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.	RPQ scores	MEAN
SECONDARY	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population)	Baseline to week 13, Months 6 and 12	1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12	RPQ scores	MEAN
SECONDARY	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population)	Baseline to week 13, Months 6 and 12	1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12	RPQ scores	MEAN
SECONDARY	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population)	Baseline to week 13, Months 6 and 12	1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12	RPQ scores	MEAN
SECONDARY	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population)	Baseline to week 13, Months 6 and 12	PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.	RPQ scores	MEAN
SECONDARY	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population)	Baseline to week 13, Months 6 and 12	PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.	RPQ scores	MEAN
SECONDARY	Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population)	Baseline to week 13, Months 6 and 12	PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.	RPQ scores	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group160

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Summary of Treatment-Emergent Adverse Events	HBO2 at 1.5 Atomspheres Absolute (ATA)	Barotitis media	13	Participants
Summary of Treatment-Emergent Adverse Events	Sham Control (1.2 Atomspheres)	Barotitis media	5	Participants
Summary of Treatment-Emergent Adverse Events	HBO2 at 1.5 Atomspheres Absolute (ATA)	Sinus barotrauma	5	Participants
Summary of Treatment-Emergent Adverse Events	Sham Control (1.2 Atomspheres)	Sinus barotrauma	3	Participants
Summary of Treatment-Emergent Adverse Events	HBO2 at 1.5 Atomspheres Absolute (ATA)	Contusion	3	Participants
Summary of Treatment-Emergent Adverse Events	Sham Control (1.2 Atomspheres)	Contusion	3	Participants
Summary of Treatment-Emergent Adverse Events	HBO2 at 1.5 Atomspheres Absolute (ATA)	Ligament sprain	0	Participants
Summary of Treatment-Emergent Adverse Events	Sham Control (1.2 Atomspheres)	Ligament sprain	5	Participants
Summary of Treatment-Emergent Adverse Events	HBO2 at 1.5 Atomspheres Absolute (ATA)	Muscle strain	1	Participants
Summary of Treatment-Emergent Adverse Events	Sham Control (1.2 Atomspheres)	Muscle strain	3	Participants

1 to 10 of 160Source ClinicalTrials.gov

See all 160 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	HBO2 at 1.5 Atomspheres Absolute (ATA)	36
Overall Study	STARTED	Sham Control (1.2 Atomspheres)	35
Overall Study	COMPLETED	HBO2 at 1.5 Atomspheres Absolute (ATA)	36
Overall Study	COMPLETED	Sham Control (1.2 Atomspheres)	32
Overall Study	NOT COMPLETED	HBO2 at 1.5 Atomspheres Absolute (ATA)	0
Overall Study	NOT COMPLETED	Sham Control (1.2 Atomspheres)	3

Source ClinicalTrials.gov

Adverse events84

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Barotitis media	Injury, poisoning and procedural complications	HBO2 at 1.5 Atomspheres Absolute (ATA)	13	36	20
other	Barotitis media	Injury, poisoning and procedural complications	Sham Control (1.2 Atomspheres)	6	35	8
other	Sinus barotrauma	Injury, poisoning and procedural complications	HBO2 at 1.5 Atomspheres Absolute (ATA)	5	36	10
other	Sinus barotrauma	Injury, poisoning and procedural complications	Sham Control (1.2 Atomspheres)	4	35	9
other	Contusion	Injury, poisoning and procedural complications	HBO2 at 1.5 Atomspheres Absolute (ATA)	6	36	8
other	Contusion	Injury, poisoning and procedural complications	Sham Control (1.2 Atomspheres)	3	35	3
other	Ligament sprain	Injury, poisoning and procedural complications	HBO2 at 1.5 Atomspheres Absolute (ATA)	0	36	0
other	Ligament sprain	Injury, poisoning and procedural complications	Sham Control (1.2 Atomspheres)	5	35	5
other	Mucsle strain	Injury, poisoning and procedural complications	HBO2 at 1.5 Atomspheres Absolute (ATA)	1	36	1
other	Mucsle strain	Injury, poisoning and procedural complications	Sham Control (1.2 Atomspheres)	3	35	3

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	HBO2 at 1.5 Atomspheres Absolute (ATA)	0	36
Total, all-cause mortality	Sham Control (1.2 Atomspheres)	0	35
Total, other adverse events	HBO2 at 1.5 Atomspheres Absolute (ATA)	35	36
Total, other adverse events	Sham Control (1.2 Atomspheres)	34	35
Total, serious adverse events	HBO2 at 1.5 Atomspheres Absolute (ATA)	5	36
Total, serious adverse events	Sham Control (1.2 Atomspheres)	3	35

Source ClinicalTrials.gov

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28768069	DERIVED	PubMed
28768070	DERIVED	PubMed
28768071	DERIVED	PubMed
28768072	DERIVED	PubMed
28768073	DERIVED	PubMed
28768075	DERIVED	PubMed
28771392	DERIVED	PubMed
30098189	DERIVED	PubMed
30099354	DERIVED	PubMed
31394600	DERIVED	PubMed

1 to 10 of 13

See all 13 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
HBO2 at 1.5 Atomspheres Absolute (ATA) vs Sham Control (1.2 Atomspheres): deaths from any cause	Trial comparisons
HBO2 at 1.5 Atomspheres Absolute (ATA) vs Sham Control (1.2 Atomspheres): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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