Hyperthermia and the Amelioration of Autism Symptoms

NCT01784744 | Completed

• 1 other identifier: 12-10-113-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; ASD; Aspergers; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Aberrant Behavior Checklist

  Screening, Day One and Day Two

Secondary Outcomes (2)

• Social Responsiveness Scale

  Screening, Day One, Day Two

• Clinical Global Impression Scale - Improvement

  Day One, Day Two

Study Arms (2)

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

Interventions

Hydroworx Pool at 98 degrees Fahrenheit OTHER

ASD Case

Hydroworx Pool at 102 degrees Fahrenheit OTHER

ASD Case; ASD Control

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aged 5 to 17
• Meets ASD criteria on the DSM-IV TR that is supported by the ADOS or the ADI-R

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Simons Foundation: collaborator

Study Sites (1)

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal samples collected for DNA and RNA extraction.

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Eric Hollander, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 24, 2017

Record last verified: 2014-11

Locations

US (1)