Hyperthermia and the Amelioration of Autism Symptoms | NCT01784744

Studies
Hyperthermia and the Amelioration of Autism Symptoms

NCT01784744

Sponsor

Montefiore Medical Center

Status

Completed

Last Update Posted

Jan 24, 2017Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Autism Spectrum Disorder

Interventions

Hydroworx Pool at 98 degrees Fahrenheit
Hydroworx Pool at 102 degrees Fahrenheit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Feb 4, 2013

First Submission Date that Met QC Criteria

Feb 5, 2013

First Posted Date

Feb 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2017

Last Update Posted Date

Jan 24, 2017Estimated

Name	Class
Simons Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hydroworx Pool at 98 degrees Fahrenheit	Other		ASD Case
Hydroworx Pool at 102 degrees Fahrenheit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aberrant Behavior Checklist		Screening, Day One and Day Two

Secondary Outcomes

Measure	Description	Time Frame
Social Responsiveness Scale		Screening, Day One, Day Two
Clinical Global Impression Scale - Improvement		Day One, Day Two

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Hollander, MD	Montefiore Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montefiore Medical Center, Albert Einstein College of Medicine		The Bronx	New York	10467	United States

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided