Cerebral Palsy

Hyperbaric Oxygen Therapy Approval Status

No Clearance by US Food and Drug Administration (FDA)

No Approval by the Undersea and Hyperbaric Medical Society (UHMS)

! Read the US Food and Drug Administration (FDA) position paper on off-label hyperbaric treatment:
Hyperbaric Oxygen Therapy: Don't Be Misled, published 22 August 2013.

About Clearance and Approval

 

Definition and Causes

Cerebral Palsy is an umbrella term for a number of neuromuscular conditions. Common symptoms include lack of muscle tone, reflexes, motor control, and coordination. By far the most common type of cerebral palsy is spastic diplegia, or Little’s disease.

CP is caused by damage to the developing brain in the womb, during childbirth, or in childhood. There is no known cure for CP, but it is not progressive. Therapeutic interventions focus on preventing complications and helping patients live with daily challenges.

Evidence Index

Approved
FDA cleared, widely reimbursed
Compelling
Strong body of evidence
Promising
Repeatedly favorable results
Scant
Early or mixed results
None
Unfavorable or no evidence
Disproved
Strong evidence against HBOT

Treatment with Hyperbaric Oxygen Therapy

There is no clinical evidence to support the use of hyperbaric oxygen therapy (HBOT) to treat cerebral palsy. Although proponents believe that HBOT should enhance neurologic function by oxygenating and repairing damaged brain tissue, registered clinical trials have not supported this hypothesis.

HyperbaricLink Commentary

The pacebo effect exerts a powerful influence over the perception of cause and effect. For those who suffer from chronic and debilitating neurologic conditions and their care-givers, the desire to find a cure is powerful and may make them susceptible to influence. This seems to be the case with cerebral palsy.

There are now multiple, randomised, blinded, sham-controlled trials of HBOT in both indications [cerebral palsy and mild traumatic brain injury]. None of these studies showed benefit of HBOT when compared to sham control, though the sham and HBOT groups often both improved, indicating that a placebo or participation effect influenced outcomes. These results almost certainly explain those of open-label trials (lacking sham controls) in which HBOT frequently seems beneficial.
SJ Mitchell, MJ Bennett, Journal of the South Pacific Underwater Medicine Society, 12/2014

Those seeking treatment for cerebral palsy should beware of practitioners making bold claims for hyperbaric oxygen therapy. Advertising a specific medical benefit from a treatment that has not been approved by the US Food and Drug Administration for that purpose is a violation of US federal law. Never pay to participate in a clinical trial.

Patient Resources

HyperbaricLink recommends the following websites for anyone seeking authoritative information, patient advocacy, and community support for cerebral palsy.

Experience Journal: Cerebral Palsy
Boston Children's Hospital

The Experience Journal is “a collection of stories, pictures, and personal experiences from families about what it has been like to contend with pediatric cerebral palsy” and includes contributions from children, families, and clinicians.

United Cerebral Palsy

Establised in 1949, United Cerebral Palsy seeks “To advance the independence, productivity and full citizenship of people with disabilities through an affiliate network.”. For those considering hyperbaric oxygen therapy for cerebral palsy, note in particular The Power of the Placebo from their Medical Director's Desk.

Clinical Resources

Start with the following resources to explore current research activities and the peer-reviewed medical literature on hyperbaric oxygen therapy for cerebral palsy.

 Use the search buttons below to go directly to research on hyperbaric oxygen therapy.

ClinicalTrials.gov
National Institutes of Health

ClinicalTrials.gov keeps the official list of human clinical trials currently enrolling, in progress, and recently completed. One may reasonably question the size and legitimacy of any study not listed here.

Search ClinicalTrials.gov

HBOEvidence

HBOEvidence uses computerized tools to appraise the key randomized controlled trials (RCTs) in the hyperbaric medical literature. One may reasonably question the overall strength of HBOT evidence for any disease or condition not covered here.

Search HBOEvidence

PubMed.gov
National Library of Medicine, US National Institutes of Health

PubMed keeps the official list of scientific papers published in reputable peer-reviewed medical journals. One may reasonably question the importance and legitimacy of any study not listed here.

Search PubMed.gov

 

News About Cerebral Palsy and Hyperbaric Oxygen Therapy

Sources
US National Institute of Neurological Disorders and Stroke, Cerebral Palsy. Retrieved 22 Apr 2011.
www.ninds.nih.gov/disorders/cerebral_palsy/cerebral_palsy.htm
United Cerebral Palsy, One Stop Resource Guide. Retrieved 10 May 2011.
www.ucp.org/resources/one-stop-resource-guide
SJ Mitchell, MJ Bennett, Unestablished indications for hyperbaric oxygen therapy, Journal of the South Pacific Underwater Medicine Society, 12/2014. Retrieved 30 July 2015
www.ncbi.nlm.nih.gov/pubmed/25596836
Page Data
Updated: 02 Aug 2015 01:38 PM
Created: 13 Jun 2009 12:00 AM
By: About the authors »