SAN DIEGO, Sept. 20, 2018 /PRNewswire/ -- AVACEN Medical, Inc. (AVACEN) announced the beginning of subject enrollment of subjects in its sponsored 12-family blinded, double placebo-controlled pilot study of ASD children ages 6-16.
The study will use the FDA-cleared AVACEN 100 dry heat therapy device to simulate a low-grade fever by non-invasively infusing heat into the circulatory system.
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 pilot study will examine improvements in the Childhood Autism Rating Scale and the Parental Stress Scale. The study will also evaluate reductions in anxiety and sleep problems reported by parents of ASD children and adolescents using the AVACEN 100*.
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. Unraveling the "fever effect" could lead to innovative ways to improve the lives of individuals affected by ASD.
The Autism Society estimates that 70 million people worldwide have ASD. Research on the costs associated with ASD conducted in the United States (e.g. Croen, et al. 2006) determined that the average cost for children with ASD were twice as high as other children for hospitalization, clinic visits, and prescription medications.
Families in San Diego interested in participating in this pilot study or further studies are encouraged to email Frances Poteet at: [email protected] and provide their phone number, email, zip code and best time to be reached.
AVACEN Medical 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, Reynaud's, and Lyme Disease. Founded in 2009, AVACEN Medical is headquartered in San Diego. Contact: Ryan Jeffcoat at (888) 428-2236 x 711 or [email protected].
E.U. and Health Canada Approval: 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; the temporary relief of widespread pain associated with fibromyalgia; muscular relaxation; and the temporary increase of microcirculation.
U.S. FDA-Clearance: 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.
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 100 on those under 18 years of age.