Clinical trial NCT01784744: Hyperthermia and the Amelioration of Autism Symptoms
Official title: Hyperthermia and the Amelioration of Autism Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: Autism
ASD
Aspergers
Autism Spectrum Disorder
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Simons Foundation
First posted: 2013-02-06
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 5 to 17 diagnosed with Autism Spectrum Disorder will be enrolled.

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.


Eligibility 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

Primary outcomes:
measure: Aberrant Behavior Checklist
timeFrame: Screening, Day One and Day Two
Secondary outcomes:
measure: Social Responsiveness Scale
timeFrame: Screening, Day One, Day Two
measure: Clinical Global Impression Scale - Improvement
timeFrame: Day One, Day Two
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center, Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Eric Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References: