Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Hyperbaric Oxygen Therapy (HBOT) on adults who are experiencing ongoing symptoms after a concussion, known as post-concussion syndrome. The goal is to see if HBOT can help reduce these symptoms, improve brain function, and enhance overall quality of life for participants who have had a concussion for at least three months. Researchers will compare the effects of HBOT to a placebo treatment (which does not involve the actual therapy) to determine its effectiveness.

To participate in the trial, individuals must be adults who were diagnosed with a concussion by a medical professional within three weeks of their injury and are still experiencing significant symptoms three to twelve months later. However, there are some health conditions that might exclude someone from participating, such as serious heart or lung issues, active infections, or certain types of medication use. Participants will undergo a series of tests to assess their symptoms, cognitive function, and quality of life before and after the treatment. This study is currently recruiting participants, and it aims to ensure safety and comfort during the hyperbaric treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Must have been evaluated within 3 weeks of injury and given a diagnosis of concussion by a medical professional
• • Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ).
• Exclusion Criteria:
• Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to:
• 1. Pulmonary:
• • COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs
• • Current pneumothorax or previous spontaneous pneumothorax
• 2. Cardiac:
• • Uncontrolled HTN (systolic \>180 or diastolic \>100)
• • Known Ejection fraction \< 35%
• • Pacemaker / ICD in place (not approved for chamber use)
• 3. Hematological/Oncological:
• • Current chemotherapeutic drug use, and past history of bleomycin use.
• • Hereditary Spherocytosis
• • Sickle cell anemia
• 4. Neurological and Psychological:
• • Implanted nerve stimulators
• • Uncontrolled seizure disorder
• • Drug or alcohol abuse/dependence
• • Current treatment for alcohol cessation with disulfiram
• • Claustrophobia
• 5. Head and Neck:
• • Inability to equilibrate the pressure of middle ears and sinuses
• • Current or previous retinal detachment
• • Retinal or vitreous surgery within the past 3 months
• 6. Miscellaneous:
• • Current fever or active infection
• • Implanted devices not on the approved list for use with HBOT
• • Women who are pregnant. Women with childbearing potential are required to use effective birth control if not surgically sterile or postmenopausal for \>2 years.
• • Undergoing vestibular or other therapy during the intervention
• • Planning a change in medication during the intervention
• • 7. Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study.
• • Asthma
• • Optic neuritis
• • Otosclerosis surgery
• • Thoracic surgery
• • Chronic sinusitis
• • 8. Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician.
• • Antabuse - Predisposes to oxygen toxicity
• • Antiseizure medications - Potential participants must have levels of their seizure medications checked within a week of their initial screening visit because low levels can predispose to oxygen toxicity. Laboratory testing must be completed by their outside treating physicians to provide to the research staff for review; the study will not obtain labs for monitoring medication levels as part of the inclusion/exclusion criteria
• • Meclizine - Predisposes to oxygen toxicity
• • Bleomycin - May cause pulmonary fibrosis that can lead to air embolism or pneumothorax in the patient receiving hyperbaric oxygen treatment.
• • Certain ointments/creams that cannot be removed - These may be allowed if covered with cotton dressings.
• • Narcotics - Can lead to cessation of the hypoxic respiratory drive.
• • Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside's vasodilator effect, making intensive monitoring mandatory.
• • Penicillin - Predisposes to oxygen toxicity
• • Promethazine (Phenergan) - Predisposes to oxygen toxicity.
• • Corticosteroids - Decreases the threshold for oxygen toxicity.
• • Sulfamylon - Promotes CO2 buildup causing peripheral vasodilatation. When coupled with vasoconstriction, results are worse than with using either agent alone. Use silver sulfadiazine instead for wound care.

Trial Officials