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Completed

NCT Number: NCT01784744

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.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroworx Pool at 98 degrees Fahrenheit

Other

Hydroworx Pool at 102 degrees Fahrenheit

Other

Primary outcomes

  1. Aberrant Behavior Checklist

    Time frame: Screening, Day One and Day Two

Secondary outcomes

  1. Social Responsiveness Scale

    Time frame: Screening, Day One, Day Two

  2. Clinical Global Impression Scale - Improvement

    Time frame: Day One, Day Two

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Simons Foundation

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 6, 2013
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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