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Hyperthermia and the Amelioration of Autism Symptoms

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ClinicalTrials.gov Identifier: NCT01784744
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Simons Foundation
Information provided by (Responsible Party):
Montefiore Medical Center

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.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: Hydroworx Pool at 98 degrees Fahrenheit Other: Hydroworx Pool at 102 degrees Fahrenheit

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hyperthermia and the Amelioration of Autism Symptoms
Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Aberrant Behavior Checklist [ Time Frame: Screening, Day One and Day Two ]

Secondary Outcome Measures :
  1. Social Responsiveness Scale [ Time Frame: Screening, Day One, Day Two ]
  2. Clinical Global Impression Scale - Improvement [ Time Frame: Day One, Day Two ]

Biospecimen Retention:   Samples With DNA
Buccal samples collected for DNA and RNA extraction.


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 5 to 17 diagnosed with Autism Spectrum Disorder will be enrolled.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784744


Locations
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United States, New York
Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Simons Foundation
Investigators
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Principal Investigator: Eric Hollander, MD Montefiore Medical Center

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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01784744     History of Changes
Other Study ID Numbers: 12-10-113-01
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: November 2014
Keywords provided by Montefiore Medical Center:
Autism
ASD
Aspergers
Autism Spectrum Disorder
Additional relevant MeSH terms:
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Fever
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Body Temperature Changes
Signs and Symptoms