Hyperthermia and the Amelioration of Autism Symptoms

Sponsor

Montefiore Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01784744

Collaborator

Simons Foundation (Other)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Other: Hydroworx Pool at 98 degrees Fahrenheit Other: Hydroworx Pool at 102 degrees Fahrenheit

Study Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Hyperthermia and the Amelioration of Autism Symptoms

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
ASD Control Patients aged 5 to 17 diagnosed with ASD.	Other: Hydroworx Pool at 102 degrees Fahrenheit
ASD Case 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 Other: Hydroworx Pool at 102 degrees Fahrenheit

Arm

Intervention/Treatment

ASD Control

Patients aged 5 to 17 diagnosed with ASD.

Other: Hydroworx Pool at 102 degrees Fahrenheit

ASD Case

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

Other: Hydroworx Pool at 102 degrees Fahrenheit

Outcome Measures

Primary Outcome Measures

Aberrant Behavior Checklist [Screening, Day One and Day Two]

Secondary Outcome Measures

Social Responsiveness Scale [Screening, Day One, Day Two]
Clinical Global Impression Scale - Improvement [Day One, Day Two]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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