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Not Yet Recruiting NCT05643482

Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

Conditions: Post-Concussion Syndrome

Sex: All
Ages: 18 Years – 45 Years
Phase: NA
Enrollment: 100
Sponsor: University of Texas Southwestern Medical Center

Summary

The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention.Specific Aims:Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms >3 months after injury.Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery.Improve quality of life as measured by the 36-Item Short Form Survey (SF-36).Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.

Eligibility Criteria

Inclusion Criteria:Must have been evaluated within 48 hours of injury and given a diagnosis of concussion by a medical professionalMust 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:Pulmonary:COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebsCurrent pneumothorax or previous spontaneous pneumothoraxCardiac:Uncontrolled HTN (systolic >180 or diastolic >100)Known Ejection fraction < 35%Pacemaker / ICD in place (not approved for chamber use)Hematological/Oncological:Current chemotherapeutic drug use, and past history of bleomycin use.Hereditary SpherocytosisSickle cell anemiaNeurological and Psychological:Implanted nerve stimulatorsUncontrolled seizure disorderDrug or alcohol abuse/dependenceCurrent treatment for alcohol cessation with disulfiramClaustrophobiaHead and Neck:Inability to equilibrate the pressure of middle ears and sinusesCurrent or previous retinal detachmentRetinal or vitreous surgery within the past 3 monthsMiscellaneous:Current fever or active infectionImplanted devices not on the approved list for use with HBOTWomen 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 interventionPlanning a change in medication during the interventionRelative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study.AsthmaOptic neuritisOtosclerosis surgeryThoracic surgeryChronic sinusitisMedications: 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 toxicityAntiseizure 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 criteriaMeclizine - Predisposes to oxygen toxicityBleomycin - 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 toxicityPromethazine (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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05643482). StuddyBuddy aggregates publicly available trial information.