Hyperthermia and the Amelioration of Autism Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Hydroworx Pool at 102 degrees Fahrenheit; Other: Hydroworx Pool at 98 degrees Fahrenheit

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center, Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 5 to 17 diagnosed with Autism Spectrum Disorder will be enrolled.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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 102 degrees Fahrenheit; Other: Hydroworx Pool at 98 degrees Fahrenheit

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Simons Foundation
• Investigators: Principal Investigator: Eric Hollander, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 6, 2013

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 22, 2017
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: ASD; Autism; Autism Spectrum Disorder; Aspergers
• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Body Temperature Changes; Heat Stress Disorders; Autistic Disorder; Autism Spectrum Disorder; Hyperthermia
• Other Study ID Numbers: 12-10-113-01