Skip to content

Hyperthermia and the Amelioration of Autism Symptoms

Hyperthermia and the Amelioration of Autism Symptoms

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01784744
Enrollment
15
Registered
2013-02-06
Start date
2012-11-30
Completion date
2013-12-31
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism, ASD, Aspergers, Autism Spectrum Disorder

Brief summary

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.

Interventions

OTHERHydroworx Pool at 98 degrees Fahrenheit
OTHERHydroworx Pool at 102 degrees Fahrenheit

Sponsors

Simons Foundation
CollaboratorOTHER
Montefiore Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Aberrant Behavior ChecklistScreening, Day One and Day Two

Secondary

MeasureTime frame
Social Responsiveness ScaleScreening, Day One, Day Two
Clinical Global Impression Scale - ImprovementDay One, Day Two

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026