What did the 2020 ALS pilot study find?

Abutaleb et al. (2020) conducted a Phase I pilot study in 10 ALS patients. The study found HBOT was safe and tolerated, with no serious adverse events. It found increased SOD2 — an antioxidant enzyme — in participants. It did not measure or show clinical benefit. PMID: 32536901.

What is the standard of care for ALS?

The standard of care for ALS includes riluzole and edaravone, which may slow progression modestly. Multidisciplinary care — respiratory support, physical therapy, speech therapy, nutritional support — helps manage symptoms and quality of life. Clinical trials are the recommended path for accessing experimental treatments.

Should an ALS patient try HBOT instead of a clinical trial?

No. For ALS, clinical trials are the recommended path for experimental treatments. They provide access to investigational therapies under careful medical supervision, often at no cost, and contribute to the evidence base that may help future patients.

Hyperbaric Oxygen Therapy and ALS: Phase I Evidence Only

Important: Hyperbaric oxygen therapy is not FDA-approved for ALS. This is an investigational use. Evidence is at the Phase I stage only — safety testing, not efficacy. Insurance will not cover HBOT for this condition. All costs are out-of-pocket.

ALS — amyotrophic lateral sclerosis — is a progressive neurodegenerative disease. It destroys the motor neurons that control voluntary movement. As those neurons die, muscles weaken and waste. Over time, ALS affects the ability to walk, speak, swallow, and breathe. Most people with ALS live 2-5 years after diagnosis, though that range varies.

There is no cure. This page will not suggest otherwise.

HBOT has been looked at in a small pilot study. The findings are narrow in scope and don’t show clinical benefit. This page explains exactly what was studied, what was found, and why the evidence is too limited to guide treatment decisions.

The Only Published Clinical Study

Abutaleb et al. (2020) conducted a Phase I pilot study. Ten ALS patients received HBOT. PMID: 32536901.

Phase I means one thing: the study was testing safety and dosing. Not effectiveness. Phase I trials aren’t designed or powered to detect clinical benefit. That comes in Phase II and Phase III.

What the study found:

HBOT was safe and well-tolerated in these 10 patients. No serious adverse events were recorded. Blood samples showed increased levels of SOD2 — superoxide dismutase 2, an antioxidant enzyme that helps neutralize harmful oxygen radicals. This is a biomarker finding, not a clinical outcome.

The study did not show that HBOT slowed ALS progression. It did not show improvements in motor function. It did not show any clinical benefit. That’s not a criticism of the study — it wasn’t designed to answer those questions. Phase I trials aren’t.

Why HBOT Is Being Studied

The biological rationale is based on what’s known about ALS disease mechanisms.

Motor neurons in ALS experience significant oxidative stress — a buildup of harmful reactive oxygen species that damage cell membranes, proteins, and DNA. Mitochondrial dysfunction is also a documented feature of ALS pathology. HBOT has been shown to reduce oxidative stress and support mitochondrial function in other contexts.

Whether these effects translate to clinical benefit in ALS is unknown. The SOD2 increase found in the pilot study is consistent with a biological response to HBOT. It doesn’t prove that response is clinically meaningful for ALS patients.

What Standard of Care Looks Like

Two FDA-approved medications are used for ALS: riluzole and edaravone. Both may slow progression modestly in some patients. Neither stops the disease.

Multidisciplinary care is the backbone of ALS management. Respiratory support — non-invasive ventilation — extends life and improves quality of life when breathing becomes compromised. Physical therapy, occupational therapy, speech therapy, and nutritional support each address specific challenges as the disease progresses.

This is what the evidence supports. It’s not everything anyone with ALS deserves, but it’s what medicine can honestly offer right now.

Why Clinical Trials Are the Better Path

For anyone with ALS who wants to try an investigational treatment, clinical trials are a better option than private-pay HBOT for several reasons.

Trials provide access to experimental treatments under careful medical supervision. Researchers monitor participants closely and can intervene if problems arise. Participation is typically free — you’re not paying $15,000-27,000 out of pocket for unproven treatment. And trial participation contributes to the evidence base that might help the next patient.

ClinicalTrials.gov lists current ALS trials, including any that involve HBOT or other emerging approaches. An ALS neurologist or an ALS Association chapter can help identify and evaluate options.

What We Don’t Know

The honest answer is that the evidence is too thin to know whether HBOT helps people with ALS. One 10-patient safety study is not enough to conclude anything about effectiveness. Larger trials would need to show clinical improvements — slowed progression, preserved function, better quality of life — before any recommendation could be made.

That evidence doesn’t exist yet.

FAQ

Is HBOT FDA-approved for ALS? No. Only Phase I safety trials have been done. No efficacy has been shown. Insurance won’t cover it.

What did the 2020 pilot study find? Safety and tolerability in 10 patients, plus increased SOD2 (antioxidant enzyme). No clinical benefit was shown. PMID: 32536901.

What’s the standard of care for ALS? Riluzole, edaravone, and multidisciplinary supportive care (respiratory support, PT, OT, speech therapy, nutrition).

Should I try HBOT instead of a clinical trial? No. Clinical trials are the recommended path for ALS experimental treatments. They’re supervised, often free, and contribute to research.

References

Abutaleb et al. (2020). Safety and Tolerability of Hyperbaric Oxygen Therapy in Amyotrophic Lateral Sclerosis: A Pilot Study. PMID: 32536901

Medical Disclaimer: This page is for informational purposes only. It does not constitute medical advice. Hyperbaric oxygen therapy for ALS is investigational and not FDA-approved. ALS is a serious progressive disease — consult a specialist at an ALS center for treatment guidance. Individual outcomes vary. This site does not establish a doctor-patient relationship.