drugset / Trial / NCT05173818

Hyperbaric Oxygen Effects on Persistent Post-concussive Symptoms

NCT05173818

RandomizedParallel-groupDouble-blindTreatment

Summary

Persistent post-concussive symptoms (PPCS) are a source of significant burden among a subset of patients with concussion with prevalence rates previously reported between 11 - 82% based on timing of assessment, diagnostic criteria, or population under study. Examples of persistent post-concussion symptoms include balance problems, headaches, fatigue, poor concentration, forgetfulness, anxiety, irritability, and sleep disturbance. Few proposed therapies have proved successful in the management of persistent post-concussion symptoms following mild traumatic brain injury. The investigators will explore hyperbaric oxygen administered in a randomized sham-controlled clinical trial as an effective and tolerable treatment in improving neuropsychological status among adult patients with persistent post-concussive symptoms. The overall hypothesis to be evaluated is that hyperbaric oxygen improves neuropsychological status and a serum concussion biomarker associated with PPCS.

Timeline

Start
2022-06-28
Primary completion
2025-08-01
Completion
2025-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxygen Other / unclassified 99.9 % Inhaled