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NCT01986205 · ClinicalTrials.gov registry record · Phase 2
Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury
A Phase 2 study, sponsored by Lindell Weaver.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT01986205 is a Phase 2 study that has completed, run by Lindell Weaver. The registered enrollment target is 49 participants.
The verdict
NCT01986205, a Phase 2 study, has completed, sponsored by Lindell Weaver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions. Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research. After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.
Interventions
- COMBINATION_PRODUCT Hyperbaric Oxygen
- COMBINATION_PRODUCT Minimal pressure air
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-09-06 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01986205
The ClinicalTrials.gov registry entry for NCT01986205 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lindell Weaver, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hyperbaric Oxygen is the first listed.
NCT01986205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01986205 about?
NCT01986205 is a clinical study titled "Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury". The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen o...
What is the current status of trial NCT01986205?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2017-09-06. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT01986205?
The interventions under investigation include: Hyperbaric Oxygen (COMBINATION_PRODUCT), Minimal pressure air (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT01986205?
This trial is sponsored by Lindell Weaver, which has 2 total clinical trials registered on ClinicalTrials.gov.
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