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NCT02407028RECRUITINGIRB Ready

Hyperbaric Oxygen Brain Injury Treatment Trial

(HOBIT)

Sponsored by Hennepin Healthcare Research Institute

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 200 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

Who Can Participate

Inclusion Criteria

Age 16 years or older and 65 years or younger
Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8.
Marshall computerized tomography (CT) score \>1 in patients with a GCS of 7 or 8 or patients with an alcohol level \>200 mg/dl
Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy/craniectomy or any other major surgical procedure OR
Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy/craniectomy or major surgical procedure

Exclusion Criteria

First hyperbaric oxygen treatment cannot be initiated within 24 hours of injury
GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm)
Penetrating head injury
Pre-existing neurologic disease (e.g. TBI or stroke or neurodegenerative disorder) with confounding residual neurologic deficits
Unstable acute spinal cord injury

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

200 participants

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Age Range

16 Years - 65 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Hennepin Healthcare Research Institute

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

San Diego

California

Location available
View San Diego location page
RECRUITING

West Palm Beach

Florida

Location available
View West Palm Beach location page
RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
RECRUITING

Lexington

Kentucky

Location available
View Lexington location page
RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page
RECRUITING

Detroit

Michigan

Location available
View Detroit location page
RECRUITING

Minneapolis

Minnesota

Location available
View Minneapolis location page
RECRUITING

Omaha

Nebraska

Location available
View Omaha location page
RECRUITING

Durham

North Carolina

Location available
View Durham location page

๐Ÿ“ And 1 more location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Traumatic Brain Injury Treatment in San Diego?

Join others in California exploring innovative treatment options through clinical research

Traumatic Brain Injury Treatment Options in San Diego, California

If you're searching for Traumatic Brain Injury treatment in San Diego, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in San Diego, West Palm Beach, Iowa City and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Traumatic Brain Injury. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 200 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Traumatic Brain Injury?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Traumatic Brain Injury

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Traumatic Brain Injury Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT02407028. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.