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Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury

NCT01986205 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-08-04

No results posted yet for this 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.

Conditions

  • Brain Injury, Chronic

Interventions

COMBINATION_PRODUCT

Hyperbaric Oxygen

Hyperbaric oxygen (USP oxygen \>99%) delivered in a hyperbaric chamber pressurized to 1.5 atmospheres absolute.

COMBINATION_PRODUCT

Minimal pressure air

Room air delivered in a hyperbaric chamber with minimal pressurization.

Sponsors & Collaborators

  • Lindell Weaver

    lead OTHER

Principal Investigators

  • Lindell K. Weaver, MD · Intermountain Health Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2022-05-31
Completion
2022-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01986205 on ClinicalTrials.gov