Hyperthermia and the Amelioration of Autism Symptoms

Study Overview
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Brief Summary
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The febrile hypothesis of Autism Spectrum Disorder (ASD) stems from the observation that clinical symptoms improve during fever. This fever induced amelioration of symptoms could be due to one of three possible causes, (1) the direct effect of temperature; (2) a resulting change in the immune inflammatory system function associated with the infection or fever; and/or (3) and increase in the functionality of a previously dysfunctional Locus Coeruleus-Noradrenerigic (LC-NA) system. Little has been done to explore the potential direct effect an increased body temperature may have on autism symptomology. Parental reports have demonstrated that during febrile episodes children with ASD have improved social cognition and language skills, and decreased disruptive behaviors. In order to further explore the direct temperature effect, further investigation is needed, which the investigators propose below. The investigators propose to complete a one year double blind crossover study with 15 children with ASD between the ages of 5 and 17 years old. Five children with ASD will complete a control protocol prior to beginning the full protocol with 10 additional ASD children. This will allow for any needed amendment of protocol parameters prior to completion of the full protocol.

Official Title
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Hyperthermia and the Amelioration of Autism Symptoms

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Hydroworx Pool at 98 degrees Fahrenheit
* Other: Hydroworx Pool at 102 degrees Fahrenheit


Participation Criteria
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Eligibility Criteria
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ASD Controls Inclusion Criteria Aged 5 to 17 Meets ASD criteria on the DSM-IV TR that is supported by the ADOS or the ADI-R ASD Control Exclusion Criteria Children who are currently ill will not begin treatment until they are well. Females who are pregnant. Children who have abnormally high blood pressure prior to starting study treatment. Children with a BMI greater than 30.0 or below 18.5 Children with history of seizures or cardiovascular problems ASD Case Inclusion Criteria Meets ASD criteria on the DSM-IV TR that is supported by the ADOS or the ADI-R Aged 5 to 17 Have a past history of improvement during febrile episodes ASD Case Exclusion Criteria Children who are currently ill will not begin treatment until they are well. Females who are pregnant. Children who have abnormally high blood pressure prior to starting study treatment. Children with a BMI greater than 30.0 or below 18.5 Children with history of seizures or cardiovascular problems

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASD Control<br>Patients aged 5 to 17 diagnosed with ASD. | Other: Hydroworx Pool at 102 degrees Fahrenheit<br> <br> |
| ASD Case<br>Patients diagnosed with ASD aged 5 to 17 with a history of amelioration of symptoms during febrile episodes. | Other: Hydroworx Pool at 98 degrees Fahrenheit<br> <br> Other: Hydroworx Pool at 102 degrees Fahrenheit<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist |  | Screening, Day One and Day Two | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Responsiveness Scale |  | Screening, Day One, Day Two | 
| Clinical Global Impression Scale - Improvement |  | Day One, Day Two | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, ASD, Aspergers, Autism Spectrum Disorder