Hyperthermia and the Amelioration of Autism Symptoms

Autism Spectrum Disorder Clinical Trial

Official title:

Hyperthermia and the Amelioration of Autism Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784744
• Other study ID #: 12-10-113-01
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: January 22, 2017
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Fever

Intervention

Other:
• Hydroworx Pool at 98 degrees Fahrenheit

• Hydroworx Pool at 102 degrees Fahrenheit

Locations

Country	Name	City	State
United States	Montefiore Medical Center, Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Simons Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aberrant Behavior Checklist		Screening, Day One and Day Two
Secondary	Social Responsiveness Scale		Screening, Day One, Day Two
Secondary	Clinical Global Impression Scale - Improvement		Day One, Day Two