Hyperbaric Oxygen Effects on Persistent Post-concussive Symptoms

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.

Conditions

• Persistent Post-concussive Syndrome
• Concussion Post Syndrome

Interventions

DRUG

Hyperbaric oxygen at 1.5 ATA

Hyperbaric oxygen (HBO2) at 1.5 ATA (active) group (hyperbaric oxygen-chamber compressed to 1.5 atmosphere absolute and breathing \>99.9% oxygen). Each participant should complete 40 sessions, one session per day, five per week over the course of 3 months.

DRUG

Sham treatment

Sham treatment includes pressurizing the chamber to 1.2 ATA with air for 5 minutes with noise of circulating air, return the chamber to 1.0 ATA after 5-7 minutes and maintain it at that pressure for until the end of the treatment, with noise of circulating air. Internal control knobs will be concealed. Participants will be instructed to undergo intermittent ear clearing technique during the initial 5 minutes of "descent"

Sponsors & Collaborators

• University of North Dakota

  collaborator OTHER

• Dakota Medical Foundation

  collaborator UNKNOWN

• The Swanson Foundation

  collaborator UNKNOWN

• State of North Dakota

  collaborator UNKNOWN

• Essentia Health

  lead OTHER

Principal Investigators

• Olayinka D Ajayi, MD, MPH · Essentia Health

• Marc Basson, MD, PhD · University of North Dakota

• Marilyn Klug, PhD · University of North Dakota

• Paulina Kunecka, MD · Essentia Health

• Richard Ferraro, PhD · University of North Dakota

• Rebecca Quinn, MSW, LMSW · Center for Rural Health, University of North Dakota

• Sharon Hanson, RN · Essentia Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-28

Primary Completion

2025-08-01

Completion

2025-08-01

FDA Drug

Yes

Countries

• United States

Study Locations