
AVACEN Medical Helps Children with Autism Spectrum Disorder (ASD)
24-Month Pilot Study – Subjects More Social, Alert, and Talkative
24-Month Pilot Study – Subjects More Social, Alert, and Talkative
CARLSBAD, CA – January 22, 2024 – AVACEN Medical (AVACEN) shared the Language Skills results from the double blinded phase of its independently conducted 12-family, placebo-controlled pilot study of ASD children, ages 4-17*.
The Fielding Graduate University IRB approved study is entitled: “The Fever Effect: Do kids with autism do better when they use a device to warm their blood? Effects of a six- week AVACEN Treatment Method on Autism Spectrum Disorder.”
The Autism Society estimates that 70 million people worldwide have ASD. The CDC estimates that the rate of ASD in children has skyrocketed, from 1 in 150 in the year 2000 to 1 in 36 in 2020. Research conducted on the costs associated with ASD in the United States (e.g. Croen, et al. 2006) determined that the average costs for children with ASD were twice as high compared to other children for hospitalizations, clinic visits, and prescriptions.
ASD “Fever Effect” - In 1980, when a viral infection swept through a therapeutic nursery for children with autism at Bellevue Psychiatric Hospital in New York, the hospital staff reported that the children were more social, alert, and talkative while feverish (Sullivan, 1980). When their fevers faded, so did those behavioral improvements. It is not unusual for parents with children on the spectrum to experience those same dramatic “Fever Effect” conditions.
According to AVACEN Medical Chairman, Thomas Muehlbauer, "The extensive 24-month study was conducted, using the FDA-Cleared, Class II, AVACEN HOME (FKA AVACEN 100) dry heat therapy device to noninvasively and safely warm their blood systemically, simulating a low-grade fever. The results demonstrated that just like the “Fever Effect,” the children became more social, alert, and talkative."
The study also evaluated changes in pragmatic language and behavior, parents’ stress levels, Autism symptom severity and reductions in sleep problems previously reported by parents of ASD children and adolescents.
According to Frances Poteet, Graduate Researcher at Fielding Graduate University in Santa Barbara, California who acted as Principal Investigator - “We have likewise seen exciting results relating to improved sleep quality and quantity without the use of medications. This is significant because sleep problems are among the most urgent concerns for families coping with ASD.”
Joshua Feder M.D., a board-certified family and child psychiatrist practicing in Solana Beach, California acted as Study Advisor. Dr. Feder, who researches ASD commented - “Although the size of this study is small, this study offers new insights in the evaluation of treatments by rating video samples of subjects before and after treatment.”
About Fielding Graduate University
Fielding Graduate University, a private university in Santa Barbara, California was founded in 1974 by Frederic M. Hudson, Hallock Hoffman, and Renata Tesch. They designed Fielding as a graduate program for mid-career professionals who were not being served by traditional universities. It offers postgraduate and doctoral studies mainly in psychology, education, and organizational studies.
About AVACEN Medical
AVACEN Medical (www.AVACEN.com) is dedicated to the innovation and design of safe, easy-to-use, noninvasive drug-free alternatives for the management of pain associated with numerous chronic and acute conditions including the temporary relief of minor muscle and joint pain and stiffness associated with arthritis and potentially other conditions that can cause joint pain, such as CRPS, Raynaud’s, and Lyme Disease. Founded in 2009, AVACEN Medical is headquartered in Carlsbad, CA. Contact: Thomas Muehlbauer, Executive Chairman at (888) 428-2236 x 701 or tmuehlbauer@AVACEN.com.
U.S. FDA-Clearance: The AVACEN HOME medical device is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and, the temporary increase of local circulation where applied.
IMPORTANT: The AVACEN 100 is not for sale in the U.S. or E.U. for any non-cleared or non-approved indication mentioned in this document.
*AVACEN recommends parents contact a physician before using the AVACEN HOME on those under 18 years of age.
Thomas Muehlbauer
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AVACEN Medical
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