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NCT01220713 · ClinicalTrials.gov registry record · Phase 2
Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)
A Phase 2 study of Mild Traumatic Brain Injury and Post Concussive Syndrome, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT01220713: Completed Phase 2 study of Mild Traumatic Brain Injury and Post Concussive Syndrome, sponsored by Virginia Commonwealth University.
NCT01220713 is a Phase 2 study of Mild Traumatic Brain Injury and Post Concussive Syndrome that has completed, run by Virginia Commonwealth University. The registered enrollment target is 60 participants, below the 219-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (73% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01220713, a Phase 2 study of Mild Traumatic Brain Injury and Post Concussive Syndrome, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this research is to serve as a demonstration project to determine the tolerability of individuals with persistent post-concussive symptoms from combat-related mild TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen) therapy, and determine the efficacy of HBO2 therapy.
Primary Outcome
Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale
Conditions Studied
Interventions
- PROCEDURE Hyperbaric Oxygen Therapy
Study Locations (3)
Virginia
- Naval Medical Center Portsmouth - Portsmouth
- Hunter Holmes McGuire Veterans' Affairs Medical Center - Richmond
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
What the finished NCT01220713 record still lists
NCT01220713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 219-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Mild Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Hyperbaric Oxygen Therapy is the first listed.
NCT01220713 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01220713 about?
NCT01220713 is a clinical study titled "Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)". The goal of this research is to serve as a demonstration project to determine the tolerability of individuals with persistent post-concussive symptoms from combat-related mild TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen) therapy, and determine the efficacy of HBO2...
What is the current status of trial NCT01220713?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2010-06. Estimated completion is 2013-07.
What conditions does trial NCT01220713 study?
This clinical trial studies the following conditions: Mild Traumatic Brain Injury, Post Concussive Syndrome.
What interventions are being tested in trial NCT01220713?
The interventions under investigation include: Hyperbaric Oxygen Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT01220713?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01220713 being conducted?
This trial has 3 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mild Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01220713's enrollment target sits among peer trials
60 29th of 43 higher than 12 of 43 other Mild Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Traumatic Brain Injury 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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