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Oxygen Therapy

Hyperbaric Oxygen Therapy for Traumatic Brain Injury

Phase 1

Waitlist Available

Led By Alison C Bested, MD FRCPC

Research Sponsored by Nova Southeastern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Chronic active infections such as HIV, hepatitis B, and hepatitis C (self-report)

Hepatic insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre- hbot and 4 weeks after hbot

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the impact of using hyperbaric oxygen therapy to treat Veterans with mild traumatic brain injury and persistent post-concussion syndrome. The goal is to help improve the physical, cognitive

Who is the study for?

This trial is for U.S. Veterans who have mild traumatic brain injuries (mTBI) or persistent post-concussion symptoms. It's aimed at those experiencing physical, cognitive, or mental health issues due to their injury.

What is being tested?

The study tests the effects of hyperbaric oxygen therapy (HBOT), where participants breathe pure oxygen in a pressurized chamber. The goal is to see if this treatment can improve symptoms from mTBI.

What are the potential side effects?

Possible side effects of HBOT include ear pressure, temporary vision changes, and lung collapse due to pressure changes; however, serious side effects are rare.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have chronic infections like HIV or hepatitis.

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My liver is not working properly.

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I have a sleep disorder like insomnia.

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My kidneys do not work properly.

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I was hospitalized for a serious head injury in the last 5 years.

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I am scheduled for surgery while receiving hyperbaric oxygen treatments.

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I have had an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre- hbot and 4 weeks after hbot

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre- hbot and 4 weeks after hbot

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- hbot and 4 weeks after hbot for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain SPECT Scan

Secondary study objectives

4-Part Continuous Performance

Brief Pain Inventory

Composite Memory

+25 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment of U.S. Veterans with mild traumatic brain injury with hyperbaric oxygen therapyExperimental Treatment2 Interventions

Pilot Study - A total of 40 HBOT treatments at 1.5 atmospheres absolute (ATA) for a dive time of 60 minutes, twice a day Monday through Friday. The treatments were separated by an air break of 4 hours on the same day. Measurements of the effectiveness of HBOT in mTBI done before and after HBOT.

0 / 7Eligibility criteria met