Hyperthermia and the Amelioration of Autism Symptoms

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Montefiore Medicine Academic Health System

Status

Completed

Conditions

Autism Spectrum Disorder

Treatments

Other: Hydroworx Pool at 98 degrees Fahrenheit
Other: Hydroworx Pool at 102 degrees Fahrenheit

Study type

Observational

Funder types

Other

Identifiers

NCT01784744
12-10-113-01

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

15 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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