Sponsor study identifier
interventional
71
1 country
5
Study Start
September 11, 2012
Actual (reported)Primary Completion
January 2015
Actual (reported)Study Completion
January 29, 2016
Actual (reported)Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy for persistent post-concussive symptoms after mild tramatic brain injury
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 29, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 3, 2012
Actual (reported)June 4, 2012
Actual (reported)September 11, 2012
Actual (reported)January 2015
Actual (reported)January 29, 2016
Actual (reported)November 21, 2018
Actual (reported)Summary of Treatment-Emergent Adverse Events
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.
months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months
Summary of Study Intervention-Related Adverse Events
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.
months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population)
Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.
Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.
Outcomes Assessment Center, Evans Army Community Hospital
Colorado Springs, Colorado, 80913, United States
Evans Army Community Hospital / Hyperbaric Medicine Complex
Fort Carson, Colorado, 80913, United States
Camp Lejeune
Jacksonville, North Carolina, 28542, United States
Joint Base Lewis-McChord
Fort Lewis, Washington, 98438, United States
TBI Program/HBO2 Research Program Madigan Healthcare system
Tacoma, Washington, 98431, United States
Weaver LK, Churchill S, Wilson SH, Hebert D, Deru K, Lindblad AS. A composite outcome for mild traumatic brain injury in trials of hyperbaric oxygen. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):341-352.
Churchill S, Deru K, Weaver LK, Wilson SH, Hebert D, Miller RS, Lindblad AS. Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):331-340.
Lindell Weaver, MD
Intermountain Health Care, Inc.
71 participants (actual enrollment reported by the registry).
First Submitted
May 3, 2012
First Posted
June 4, 2012
Study Start
September 11, 2012
Actual (reported)Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy
Baseline
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
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
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
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
The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hart BB, Wilson SH, Churchill S, Deru K, Weaver LK, Minnakanti M, Lindblad AS. Extended follow-up in a randomized trial of hyperbaric oxygen for persistent post-concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):313-327.
Wetzel PA, Lindblad AS, Mulatya C, Kannan MA, Villmar Z, Gitchel GT, Weaver LK. Eye tracker outcomes in a randomized trial of 40 sessions of hyperbaric oxygen or sham in participants with persistent post concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):299-311.
Walker JM, Mulatya C, Hebert D, Wilson SH, Lindblad AS, Weaver LK. Sleep assessment in a randomized trial of hyperbaric oxygen in U.S. service members with post concussive mild traumatic brain injury compared to normal controls. Sleep Med. 2018 Nov;51:66-79. doi: 10.1016/j.sleep.2018.06.006. Epub 2018 Jun 30.
Wetzel PA, Lindblad AS, Raizada H, James N, Mulatya C, Kannan MA, Villamar Z, Gitchel GT, Weaver LK. Eye Tracking Results in Postconcussive Syndrome Versus Normative Participants. Invest Ophthalmol Vis Sci. 2018 Aug 1;59(10):4011-4019. doi: 10.1167/iovs.18-23815.
Meehan A, Searing E, Weaver LK, Lewandowski A. Baseline vestibular and auditory findings in a trial of post-concussive syndrome. Undersea Hyperb Med. 2016 Aug-Sept;43(5):567-584.
Wilson SH, Weaver LK, Lindblad AS. Neuropsychological assessments in a hyperbaric trial of post-concussive symptoms. Undersea Hyperb Med. 2016 Aug-Sept;43(5):585-599.
Walker JM, James NT, Campbell H, Wilson SH, Churchill S, Weaver LK. Sleep assessments for a mild traumatic brain injury trial in a military population. Undersea Hyperb Med. 2016 Aug-Sept;43(5):549-566.
Mirow S, Wilson SH, Weaver LK, Churchill S, Deru K, Lindblad AS. Linear analysis of heart rate variability in post-concussive syndrome. Undersea Hyperb Med. 2016 Aug-Sept;43(5):531-547.
Williams CS, Spitz MC, Foley JF, Weaver LK, Lindblad AS, Wierzbicki MR. Baseline EEG abnormalities in mild traumatic brain injury from the BIMA study. Undersea Hyperb Med. 2016 Aug-Sept;43(5):521-530.
Williams CS, Weaver LK, Lindblad AS, Kumar S, Langford DR. Baseline neurological evaluations in a hyperbaric trial of post-concussive syndrome. Undersea Hyperb Med. 2016 Aug-Sept;43(5):511-519.
Weaver LK, Chhoeu A, Lindblad AS, Churchill S, Wilson SH. Hyperbaric oxygen for mild traumatic brain injury: Design and baseline summary. Undersea Hyperb Med. 2016 Aug-Sept;43(5):491-509.
Primary Completion
January 2015
Actual (reported)Study Completion
January 29, 2016
Actual (reported)Last Updated
November 21, 2018
Results First Posted
November 21, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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