Clinical Trials Directory

Trials / Completed

CompletedNCT01784744

Hyperthermia and the Amelioration of Autism Symptoms

Status
Completed
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
Montefiore Medical Center · Academic / Other
Sex
All
Age
5 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2012-11-01
Primary completion
2013-11-01
Completion
2013-12-01
First posted
2013-02-06
Last updated
2017-01-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01784744. Inclusion in this directory is not an endorsement.