Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury

NCT00830453 | Completed Phase 2

• 1 other identifier: 950-352
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to discover the feasibility of conducting clinical research in individuals with chronic sequelae following brain injury who are given hyperbaric oxygen. This study will also look at the outcome of individuals with a chronic stable brain injury due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength, etc.) measures will be performed before the hyperbaric sessions, immediately following them, and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.

Conditions

Brain Injury; Sequelae; Stroke; Anoxia; Trauma

Keywords

Brain injury with sequelae from stroke, anoxia, or trauma

Outcome Measures

Primary Outcomes (1)

• With this feasibility trial we wish to determine if we can recruit suitable subjects and if they will be able to comply with the protocol and tolerate 60 hyperbaric oxygen sessions.

  Immediately following completion of final hyperbaric oxygen session

Secondary Outcomes (1)

• To estimate the immediate and long-term effects of hyperbaric oxygen therapy on subjects with chronic brain injury. This feasibility trial may be underpowered to demonstrate efficacy, or not, with hyperbaric oxygen.

  Outcome measures performed immediately after final hyperbaric oxygen session and 6 months later.

Study Arms (1)

Hyperbaric oxygen

EXPERIMENTAL

Hyperbaric oxygen, 1.5 atmospheres absolute, 60 minutes door-to-door, 60 daily sessions.

Procedure: Hyperbaric oxygen therapy (HBO2)

Interventions

Hyperbaric oxygen therapy (HBO2) PROCEDURE

60 daily hyperbaric oxygen sessions 1.5 atmospheres absolute, 100% oxygen 60 minutes per session, from door closing to door opening

Hyperbaric oxygen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has had a brain injury at least 12 months prior to study enrollment.
• Subject is at least 18 years old.
• Etiology of brain injury: Stroke, anoxia, and trauma
• Must be able to equalize ears, or have tympanostomy tubes
• Willingness to complete outcome measures and complies with the research protocols.
• Commitment to pay the hospital for hyperbaric oxygen.

You may not qualify if:

• Glasgow Coma Scores less than 13 at the time of hyperbaric oxygen evaluation.
• Inability to participate in outcome assessments (eg: blindness, quadraplegia)
• Claustrophobia (unwillingness or inability to enter the hyperbaric chamber).
• Inability to equalize ears. The patient could elect to have bilateral tympanostomy tubes.
• Inability to protect airway, and or requiring frequent suctioning.
• Patients requiring tracheostomy will be ineligible due to limitations in autoinflation of the middle ear space and difficulty to perform airway suctioning in the single-person chamber.
• Pregnancy (beta HCG will be assayed in women who could be pregnant prior to enrollment).
• Severe psychiatric disorders such as schizophrenia and bi-polar disease. We appreciate that psychiatric problems such as depression and anxiety may follow brain injuries so we would not exclude patients based on brain-injury induced psychiatric disorders, but will exclude patients with severe pre-injury psychiatric disorders.
• Patients taking lithium (due to the possibility of concomitant toxic side effects with hyperbaric oxygen therapy, specifically hyperexcitability).
• Degenerative Mental Disease (eg: Alzheimer's, multiple sclerosis, senile dementia, severe psychiatric disorder (schizophrenia, bi-polar disease, etc.).
• Presence of chronic debilitating disease (end-stage renal disease, end-stage liver disease, diabetes with sequelae).
• Heart failure patients with ejection fractions less than 50% or inability to lay supine.
• Patients with active malignancy, or prior treatment with cisplatin or bleomycin (there is some evidence that prior cisplatin and bleomycin therapy may place the patient at increased risk for serious oxidated stress with inhalation of high concentrations of oxygen).
• Evidence of current recreational drug use, either by history, or by comprehensive urine drug testing (due to confounds on outcome measure interpretation).
• Consumption of more than the equivalent of 12 beers/week habitually.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Deseret Foundation: collaborator

Study Sites (1)

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Related Publications (1)

• Churchill S, Weaver LK, Deru K, Russo AA, Handrahan D, Orrison WW Jr, Foley JF, Elwell HA. A prospective trial of hyperbaric oxygen for chronic sequelae after brain injury (HYBOBI). Undersea Hyperb Med. 2013 Mar-Apr;40(2):165-93.

  PMID: 23682548 DERIVED

MeSH Terms

Conditions

Brain Injuries; Stroke; Hypoxia; Wounds and Injuries

Interventions

Hyperbaric Oxygenation; Oxyhemoglobins

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins

Study Officials

• Susan K. Churchill, APRN-NP

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

• Lindell K. Weaver, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: November 1, 2003
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 15, 2021

Record last verified: 2011-09

Locations

US (1)