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NCT01611194 · ClinicalTrials.gov registry record · Phase 2
mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms
A Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT01611194: Completed Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.
NCT01611194 is a Phase 2 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611194, a Phase 2 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
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
Primary Outcome
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.
Interventions
- DRUG Hyperbaric oxygen (HBO2) at 1.5 atms
- DRUG Sham control 1.2 atms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2012-09-11 |
| Est. Completion | 2016-01-29 |
| Phase | Phase 2 |
What the finished NCT01611194 record still lists
NCT01611194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Hyperbaric oxygen (HBO2) at 1.5 atms is the first listed.
NCT01611194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01611194 about?
NCT01611194 is a clinical study titled "mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms". 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
What is the current status of trial NCT01611194?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2012-09-11. Estimated completion is 2016-01-29.
What interventions are being tested in trial NCT01611194?
The interventions under investigation include: Hyperbaric oxygen (HBO2) at 1.5 atms (DRUG), Sham control 1.2 atms (DRUG).
Who is sponsoring clinical trial NCT01611194?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01611194's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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