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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01322984
Other study ID # 2010/238
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 2, 2011
Last updated October 24, 2012
Start date March 2011

Study information

Verified date October 2012
Source University of Tromso
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Interventional

Clinical Trial Summary

Children and youth diagnosed with autism spectrum disorder (ASD) have been shown to react abnormally to social stimuli, especially to human faces. Children and youth with ASD show less interest in social stimuli, and may even avoid looking at or interact with such stimuli. It has been proposed that social stimuli elicit reactions like fear and stress in individuals with ASD, and this explains the lack of interest and avoidance. The present project investigates this hypothesis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 18 Years
Eligibility For ASD group:

Inclusion Criteria:

- Diagnosed with autism spectrum disorders

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Pictures
The participants will be exposed to pictures of faces and non-facial stimuli presented on a PC screen.
Startle eliciting noise
Startle will be elicited by 95 dB noise, presented at different times after picture onset.

Locations

Country Name City State
Norway Department of Psychology, University of Tromso Tromso Troms

Sponsors (2)

Lead Sponsor Collaborator
University of Tromso The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary The eyeblink of the Startle reflex is measured. The startle reflex is potentiated when participants are influenced by negative emotions. Accordingly, startle will be measured in relation to picture presentation to gauge the emotional effect of the pictures. It is expected that the ASD group will show fear potentiated startle to pictures of human faces. The startle reflex will be measured in relation to picture presentations during the experiment (e.g. day 1). No
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