Hyperthermia and the Amelioration of Autism Symptoms

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Hydroworx Pool at 98 degrees Fahrenheit; Other: Hydroworx Pool at 102 degrees Fahrenheit

• Registration Number: NCT01784744
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-06
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2017-01-22
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD Case	Hydroworx Pool at 98 degrees Fahrenheit	Patients diagnosed with ASD aged 5 to 17 with a history of amelioration of symptoms during febrile episodes.
ASD Control	Hydroworx Pool at 102 degrees Fahrenheit	Patients aged 5 to 17 diagnosed with ASD.
ASD Case	Hydroworx Pool at 102 degrees Fahrenheit	Patients diagnosed with ASD aged 5 to 17 with a history of amelioration of symptoms during febrile episodes.

Primary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist	Screening, Day One and Day Two

Secondary Outcome Measures

Name	Time	Method
Social Responsiveness Scale	Screening, Day One, Day Two
Clinical Global Impression Scale - Improvement	Day One, Day Two

Trial Locations

Locations (1)

Montefiore Medical Center, Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States