Clinical trial NCT02818205: Electrodermal Patterns of Arousal in Children
Official title: Electrodermal Patterns of Arousal in Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Lead sponsor: Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 32
Sex: MALE
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of boys between the ages of 4 - 11 years with and without a diagnosis of Autism Spectrum Disorder were recruited from private and public New Jersey Schools, Barpak Occupational Therapy clinic, Bergenfield, New Jersey and Seton Hall University campus.

Brief summary: The purpose of this study was to explore the feasibility of detecting physiological patterns of arousal to sensory inputs in children with and without Autism Spectrum Disorder (ASD). Accordingly, two questions directed this methodological research investigation: (1) Is there a relationship between rest (tonic) and response (phasic) patterns of arousal among typically developing children and children with ASD?, and (2) Is there a difference in EDA response to sensation between typically developing children and children with ASD?

Detailed description: This methodological research design is a prospective exploratory test-retest design assessing the relationship between tonic and phasic Electrodermal Activity (EDA) variables. EDA during rest and in response to a variety of sensations was measured using skin conductance. Descriptive statistics summarized EDA dependent variable data using skin conductance response (SCR) magnitude, SCR amplitude, skin conductance level (SCL), non-specific response (NSR) and habituation (HAB). The data was used to assess the relationship between tonic and phasic patterns of arousal and compare response patterns between groups using the Sensory Challenge Protocol (SCP) in children with ASD and typically developing children (TD).

Eligibility criteria: Inclusion Criteria: Boys ages 4 - 11 years old.

* Able to sit for 30 minutes and follow simple directions.
* Children with confirmed Autism Spectrum Disorder via School records or parent report.
* Typically developing children free of medical or neurological conditions.

Exclusion Criteria:

* Medical or neurological conditions other than Autism.
* Hearing loss or visual impairments.
* Children taking medications known to affect arousal.
* Children who are not able to follow simple commands.

Primary outcomes:
measure: Electrodermal Activity in response to sensation: tonic and phasic skin conductance in MicroSiemens
timeFrame: Within six weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Schoen SA, Miller LJ, Brett-Green BA, Nielsen DM. Physiological and behavioral differences in sensory processing: a comparison of children with autism spectrum disorder and sensory modulation disorder. Front Integr Neurosci. 2009 Nov 3;3:29. doi: 10.3389/neuro.07.029.2009. eCollection 2009.
citation: Vetrugno R, Liguori R, Cortelli P, Montagna P. Sympathetic skin response: basic mechanisms and clinical applications. Clin Auton Res. 2003 Aug;13(4):256-70. doi: 10.1007/s10286-003-0107-5.