Essentia to study whether hyperbaric oxygen therapy can help concussion victims

FARGO — Hyperbaric oxygen treatment — oxygen given under pressure inside a special chamber — has been proven effective as a therapy for 14 conditions, including eye strokes, skin ulcers from diabetes and bladder damage from radiation treatments.

Now, there is growing interest in using hyperbaric oxygen to treat concussions. Some studies have shown promise, but questions remain that a study led by Essentia Health in Fargo hopes to answer.

Essentia is launching a three-year study to evaluate the effectiveness of hyperbaric oxygen treatments given to adults with persistent concussion symptoms. The study is supported by the state of North Dakota and Dakota Medical Foundation and also involves the University of North Dakota.

Hyperbaric oxygen treatments help healing in two ways, said Dr. Olayinka Ajayi, a hyperbaric medicine physician at Essentia who is involved in the study.

One mechanism is through bubble pressure, which dispels bubbles in veins. “Hyperbaric can help with shrinking the bubbles,” treating conditions including decompression, better known as the “bends,” which scuba divers can get if they surface too rapidly.

Hyperbaric oxygen also delivers therapeutic benefits by increasing oxygen in the bloodstream, triggering a “cascade” of healing reactions, including stem-cell mobilization, Ajayi said.

“That high oxygen is used for wound healing,” including the hard-to-heal skin ulcers that diabetics can develop, he said.

Treatments involve breathing oxygen that is increased two or three times greater than normal in a pressurized chamber, allowing the lungs to inhale much more oxygen than normal, helping the body to fight bacteria, recruit stem cells and promote healing.

Essentia has provided hyperbaric oxygen treatments since June of 2021 for the 14 diseases or conditions approved by the Food and Drug Administration, uses also approved by Medicare and many other health insurers, Ajayi said.

Before joining Essentia, during fellowship training at Hennepin Healthcare in Minneapolis, Ajayi saw hyperbaric oxygen treatments successfully treat all 14 FDA-approved uses, including eye stroke — which involves a blockage of the artery that supports the retina — diabetic skin wounds, radiation damage to the bladder from prostate cancer treatment, and sudden hearing loss.

“There’s strong evidence that hyperbaric helps those wounds heal, and I’ve seen it repeatedly,” he said, referring to healing skin ulcers on diabetics’ feet.

The treatments also have shown to be effective in treating carbon monoxide poisoning and frostbite.

So far, five studies have examined hyperbaric oxygen treatments for persistent concussion symptoms, including four in the United States, all by branches of the military. No U.S. studies have been done involving the general public, Ajayi said.

Studies to date have relied upon patients’ responses on questionnaires. “Most of these are subjective,” he said. Typical questions ask subjects how they feel or how well they slept, for example.

The Essentia study will use a biomarker in patients’ blood — a protein that indicates nerve damage — as well as the questionnaires, he said.

“The blood will not lie,” Ajayi said, adding that use of the biomarker will distinguish the Essentia study from previous studies.

The Essentia study received $335,000 from the state of North Dakota. The North Dakota Legislature provided support for the study because of concerns of concussions from sports injuries and blast effects suffered by combat veterans who served in Iraq and Afghanistan, Ajayi said.

Many others also suffer concussions from falls or car accidents, for instance, he said, adding, “It’s across the spectrum.”

The study will be randomized, with two arms, each with 50 participants. One group will be given hyperbaric oxygen, the other regular air. Participants won’t know which they will receive.

Michael Vosburg / The Forum

To be eligible, participants must be adults and must be referred by their medical provider to the neurology department at Essentia in Fargo. Study candidates will be screened by Dr. Pauline Kunecka, an Essentia neurologist, to determine whether they qualify.

Patients participating in the study must have experienced an episode or episodes of concussion occurring more than three months ago and less than five years ago and still be experiencing related symptoms.

Study participants will receive 42 on-site treatments in the first three months, followed by four more visits over the next 21 months. Side effects will be monitored throughout.

Baseline tests will be performed before the treatments and compared to results after treatment. Patients will be followed for two years.

Research exploring the effectiveness of hyperbaric oxygen treatments also is being carried out for irritable bowel disease, “long haul” COVID-19, bone fracture healing and vascular dementia, among other diseases and conditions.

Hyperbaric oxygen has been shown to be ineffective in treating cancer — “That’s fraud, basically” — and acute COVID-19, Ajayi said.

Sharon Hanson, a registered nurse at Essentia, will be involved in tracking patients in the study. Those who are interested in learning more about the concussion study can call Essentia in Fargo at 701-364-7555.