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NCT01784744 · ClinicalTrials.gov registry record
Hyperthermia and the Amelioration of Autism Symptoms
A clinical trial, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- 15
- Enrollment target
NCT01784744 is a clinical trial that has completed, run by Montefiore Medical Center. The registered enrollment target is 15 participants.
The verdict
NCT01784744 has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study 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.
Interventions
- OTHER Hydroworx Pool at 98 degrees Fahrenheit
- OTHER Hydroworx Pool at 102 degrees Fahrenheit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01784744
The ClinicalTrials.gov registry entry for NCT01784744 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hydroworx Pool at 98 degrees Fahrenheit is the first listed.
NCT01784744 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01784744 about?
NCT01784744 is a clinical study titled "Hyperthermia and the Amelioration of Autism Symptoms". 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 inflam...
What is the current status of trial NCT01784744?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2012-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01784744?
The interventions under investigation include: Hydroworx Pool at 98 degrees Fahrenheit (OTHER), Hydroworx Pool at 102 degrees Fahrenheit (OTHER).
Who is sponsoring clinical trial NCT01784744?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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