Autism Spectrum DisorderNCT01784744
Hyperthermia and the Amelioration of Autism Symptoms
An observational study of Autism Spectrum Disorder, run by Montefiore Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Hydroworx Pool at 98 degrees Fahrenheit and Hydroworx Pool at 102 degrees Fahrenheit
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 5 to 17 diagnosed with Autism Spectrum Disorder will be enrolled.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, 10467
About this study
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
- Being tested
- Hydroworx Pool at 98 degrees Fahrenheit, Hydroworx Pool at 102 degrees Fahrenheit
- Keywords
- Autism, ASD, Aspergers, Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroworx Pool at 98 degrees FahrenheitOther
Hydroworx Pool at 102 degrees FahrenheitOther
| Study group | Role | What they receive |
|---|---|---|
| ASD Control | Patients aged 5 to 17 diagnosed with ASD. Receives: 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. Receives: Other: Hydroworx Pool at 98 degrees Fahrenheit; Other: Hydroworx Pool at 102 degrees Fahrenheit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist
Measured: Screening, Day One and Day Two
Secondary outcomes (2)
Social Responsiveness Scale
Measured: Screening, Day One, Day Two
Clinical Global Impression Scale - Improvement
Measured: Day One, Day Two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Simons Foundation
- Responsible party
- Sponsor
- Investigators
- Eric Hollander, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784744
- Sponsor's protocol ID
- 12-10-113-01
- Status last verified
- Nov 2014
- First submitted
- 4 Feb 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperthermia and the Amelioration of Autism Symptoms
- ClinicalTrials.gov ID
- NCT01784744
- Acronym / sponsor ID
- 12-10-113-01
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, ASD, Aspergers, Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Simons Foundation
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD Control | – | Other: Hydroworx Pool at 102 degrees FahrenheitPatients aged 5 to 17 diagnosed with ASD. |
| ASD Case | – | Other: Hydroworx Pool at 98 degrees Fahrenheit, Other: Hydroworx Pool at 102 degrees FahrenheitPatients diagnosed with ASD aged 5 to 17 with a history of amelioration of symptoms during febrile episodes. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 5 to 17 diagnosed with Autism Spectrum Disorder will be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroworx Pool at 98 degrees Fahrenheit | Other | ASD Case |
| Hydroworx Pool at 102 degrees Fahrenheit | Other | ASD Case, ASD Control |
Primary outcome
Aberrant Behavior Checklist
Time frame: Screening, Day One and Day Two
2 secondary outcomes
Social Responsiveness Scale
Time frame: Screening, Day One, Day Two
Clinical Global Impression Scale - Improvement
Time frame: Day One, Day Two
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hollander, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist (time frame: Screening, Day One and Day Two). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.