Hyperthermia and the Amelioration of Autism Symptoms



Status:Completed
Conditions:Infectious Disease, Neurology, Psychiatric, Autism
Therapuetic Areas:Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:5 - 17
Updated:5/5/2014
Start Date:November 2012
End Date:July 2013
Contact:Tara Kahn, BA
Email:tkahn@montefiore.org
Phone:855-411-7792

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
1
site
?
mi
from
Bronx, NY
Click here to add this to my saved trials