Cognitive rigidity and risperidone in children with autism spectrum disorders

Cognitive rigidity and risperidone in children with autism spectrum disorders - Rigidity and risperidone in autism spectrum disorders

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34499

Enrollment

Registered

2010-11-30

Start date

2011-02-11

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autisme spectrum stoornissen 'Autism Spectrum DIsorders' or 'autism'

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children aged 6 to 12, who are diagnosed with ASD at the department of child psychiatry. All children who will be prescribed risperidone for stereotypic behavior, but who are medication-naive at the beginning of the study, will be asked to participate. Based on the known male: female ratio of about 4:1 (Fombonne, 2002), we expect to include around 20 boys and 5 girls in our study. Diagnostic criteria are according to the DSM-IV (APA, 1994), and verified by the ADOS (Lord et al., 1989) and ADI-R (Lord et al., 1994). IQs of all participants will be measured by the Wechsler Intelligence Scale for Children, Dutch edition (WISC-III-NL).

Exclusion criteria

Exclusion criteria: Individuals who are either not medication-naive at baseline, with a known brain dysfunction, total IQ score below 75 or with psychiatric pathology other than ASD will be excluded.

Design outcomes

Primary

Measure	Time frame
The Error-Related negativity (ERN) is a peak in the ERP signal measured directly after the participant makes a mistake; in the case of the Go/ NoGo task, this means that the ERN is measured when the participant inadvertently presses the response button with a NoGo trial. The ERN is a measure of self-monitoring, which is hypothesized to be low in children with ASD with rigid behavior at baseline. The use of risperidone enhances cingulate cortex activity, resulting in larger ERN amplitudes. Response times, and particularly the delay in reaction time after making a mistake, are also measured. Usually, the reaction times after an erronous response are slower; we expect that this post-error slowing at baseline is relatively small in children with ASD, but that it increases due to the use of risperidone. Both effect measures will be correlated with the degree of rigid behavior in the children with ASD, here we expect stronger effects with higher levels of rigid behavior at baseline.	—

Measure

Time frame

The Error-Related negativity (ERN) is a peak in the ERP signal measured directly after the participant makes a mistake; in the case of the Go/ NoGo task, this means that the ERN is measured when the participant inadvertently presses the response button with a NoGo trial. The ERN is a measure of self-monitoring, which is hypothesized to be low in children with ASD with rigid behavior at baseline. The use of risperidone enhances cingulate cortex activity, resulting in larger ERN amplitudes. Response times, and particularly the delay in reaction time after making a mistake, are also measured. Usually, the reaction times after an erronous response are slower; we expect that this post-error slowing at baseline is relatively small in children with ASD, but that it increases due to the use of risperidone. Both effect measures will be correlated with the degree of rigid behavior in the children with ASD, here we expect stronger effects with higher levels of rigid behavior at baseline.

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Secondary

Measure	Time frame
Source localizations of the ERN are applied, meaning that it is measured whether the ERN can actually be located in the anterior cingulate cortex. This source localization is done by using Brain Electrical Source Analysis software. Previous studies have shown that using 64 electrodes, as it is the case in our study, will provide robust signals that are appropriate for measuring ERN source localization (Vlamings et al, 2008).	—

Measure

Time frame

Source localizations of the ERN are applied, meaning that it is measured whether the ERN can actually be located in the anterior cingulate cortex. This source localization is done by using Brain Electrical Source Analysis software. Previous studies have shown that using 64 electrodes, as it is the case in our study, will provide robust signals that are appropriate for measuring ERN source localization (Vlamings et al, 2008).

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Countries

Netherlands

Outcome results