Focus of the Report: The focus of this Health Technology Assessment is to evaluate the safety and effectiveness of systemic hyperbaric oxygen therapy (HBOT) to treat adults with persistent post-concussive syndrome (PCS) after mild traumatic brain injury (mTBI).

Technology Description: HBOT is a medical intervention by which a patient breathes near 100% oxygen while inside a hyperbaric chamber pressurized to ≥ 1.4 atmosphere absolute (ATA). In the analyzed studies of HBOT for PCS, patients stayed in the chamber for 60 to 90 minutes, with a full course of treatment usually comprising 30 to 40 sessions administered over several weeks on an outpatient basis.

Controversy: HBOT is an established therapy with regulatory clearance for over a dozen indications. Any role that HBOT might have in the treatment of patients with persistent PCS after mTBI has not been defined in clinical studies. Controversial issues related to HBOT include patient selection, dosing and frequency of treatment, and selection of evaluable and clinically meaningful outcome measures/endpoints as well as the reliability of sham HBOT as a comparator.

Key Questions:

  • Is HBOT effective for the treatment of persistent PCS in adults with mTBI?

  • How does HBOT compare with other treatment modalities for the treatment of patients with persistent PCS?

  • Is HBOT in patients with persistent PCS safe?

  • Have definitive patient selection criteria been identified for HBOT in patients with persistent PCS?

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