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Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Syntocinon (Oxytocin)
Placebo (Physiological water (solution of sodium chloride (NaCl) in water))
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Oxytocin, Autism Spectrum Disorders

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Autism Spectrum Disorder, Asperger Syndrome or Autism
  • Male
  • Age between 18 and 40 years old

Exclusion Criteria:

  • Associated neuro(psycho)logical disorder (i.e. epilepsy, concussion, stroke)
  • Eye sight worse than + or - 7
  • Genetic syndrome
  • Color blindness
  • Any contraindication to neuroimaging research as assessed with the MRI screening list:

MRI contraindications:

pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or implanted pump, a neurostimulator or VP shunt, any metallic object in the eyes (metallic fragments)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Syntocinon (Oxytocin, product code RVG 03716)

    Placebo (Physiological water(sodium chloride (NaCl) solution))

    Arm Description

    Administration via nasal spray

    Administration via nasal spray

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray
    Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) After a Single Dose of Nasal Spray BOLD response (Blood-oxygen-level-dependent response)
    Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray
    Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 4 weeks of nasal spray BOLD response (Blood-oxygen-level-dependent response)
    Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray
    Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 8 weeks, including 4 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response)
    Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray
    Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 52 weeks, including 48 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response)
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray
    Change from baseline in brain connectivity during rest (resting-state fMRI) after 4 weeks of nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray
    Change from baseline in brain connectivity during rest (resting-state fMRI) after 8 weeks, including 4 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray
    Change from baseline in brain connectivity during rest (resting-state fMRI) after 52 weeks, including 48 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)

    Secondary Outcome Measures

    Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray
    Change from baseline in performance on the emotion recognition task (accuracy/reaction time) after a single dose of nasal spray Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.
    Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray
    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 4 weeks of nasal spray. Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.
    Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray)
    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 8 weeks (including 4 weeks without nasal spray). Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.
    Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray)
    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 52 weeks (including 48 weeks without nasal spray) Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.
    Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 4 Weeks of Nasal Spray
    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.
    Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 8 Weeks, Including 4 Weeks Without Nasal Spray
    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.
    Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 52 Weeks, Including 48 Weeks Without Nasal Spray
    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QOL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.
    Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray
    Change from baseline in scores on one questionnaire assessing mood (Profile of Mood States - POMS) after a single dose of nasal spray. This instrument comprises emotional adjectives subdivided in five domains: tension (6 items). depression (8 items). vigor (5 items). fatigue (6 items) and anger (7 items) which have to be rated on a five-point Likert scale ranging from 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a lot), to 4 (extremely). Only for the vigor scale, higher scores indicate improvement.

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    January 26, 2021
    Sponsor
    KU Leuven
    Collaborators
    The Branco Weiss Fellowship, Research Foundation Flanders
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02940574
    Brief Title
    Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders
    Official Title
    Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    KU Leuven
    Collaborators
    The Branco Weiss Fellowship, Research Foundation Flanders

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of complex social behaviors. Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD. However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.
    Detailed Description
    The present study is a monocentric, between-subjects, randomized, placebo-controlled trial. The investigators will recruit approximately 40 young-adult, male individuals with a clinical diagnosis of Autism Spectrum Disorder (ASD). Participants will be randomly allocated to an experimental group (Oxytocin (OT)) and a control group (Placebo (PL)). All participants will receive the same frequency and duration of intervention. Behavioral and neural outcome measures will be assessed at multiple time points in a period of a year. Participants will be tested at 5 occasions: before and after a single dose of nasal spray, after multiple doses of nasal spray (1 daily dose of nasal spray during 4 weeks), after a 4-week retention period and after a 1-year retention period. At each time point participants will be tested at both the behavioral and neural level. Test performance of both participant groups (OT vs PL) will be compared by measuring reaction times and accuracy rates in a computerized task assessing a person's ability to recognize bodily emotional states from point light displays. In addition, attachment, social functioning, restricted behaviour, general quality of life and mood will be assessed via self-reported questionnaires. Functional MRI measurements will be performed in a 3T MR Philips Intera scanner. Before scanning, subjects will undergo a training session to familiarize them with the task instructions. In addition to the fMRI measurements, resting state fMRI and Diffusion Tensor Imaging (DTI) will also be performed to reveal alterations of the functional and structural connectivity between critical regions. Statistical analysis of the behavioral data will have a between-subject factor of group (OT vs PL) and within-subject factors of time (change-from-baseline). Image analysis will be performed with Statistical Parametric Mapping (SPM) software. The investigators will contrast for either decreased or increased activation, as different regions may show divergent changes due to the received nasal spray (either OT or PL).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorders
    Keywords
    Oxytocin, Autism Spectrum Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Syntocinon (Oxytocin, product code RVG 03716)
    Arm Type
    Experimental
    Arm Description
    Administration via nasal spray
    Arm Title
    Placebo (Physiological water(sodium chloride (NaCl) solution))
    Arm Type
    Placebo Comparator
    Arm Description
    Administration via nasal spray
    Intervention Type
    Drug
    Intervention Name(s)
    Syntocinon (Oxytocin)
    Intervention Description
    Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
    Intervention Type
    Other
    Intervention Name(s)
    Placebo (Physiological water (solution of sodium chloride (NaCl) in water))
    Intervention Description
    Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray
    Description
    Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) After a Single Dose of Nasal Spray BOLD response (Blood-oxygen-level-dependent response)
    Time Frame
    Value at 30 minutes minus value at baseline
    Title
    Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray
    Description
    Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 4 weeks of nasal spray BOLD response (Blood-oxygen-level-dependent response)
    Time Frame
    Value at 4 weeks minus value at baseline
    Title
    Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray
    Description
    Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 8 weeks, including 4 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response)
    Time Frame
    Value at 8 weeks minus value at baseline
    Title
    Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray
    Description
    Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 52 weeks, including 48 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response)
    Time Frame
    Value at 52 weeks minus value at baseline
    Title
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray
    Description
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)
    Time Frame
    Value at 30 minutes minus value at baseline
    Title
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray
    Description
    Change from baseline in brain connectivity during rest (resting-state fMRI) after 4 weeks of nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)
    Time Frame
    Value at 4 weeks minus value at baseline
    Title
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray
    Description
    Change from baseline in brain connectivity during rest (resting-state fMRI) after 8 weeks, including 4 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)
    Time Frame
    Value at 8 weeks minus value at baseline
    Title
    Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray
    Description
    Change from baseline in brain connectivity during rest (resting-state fMRI) after 52 weeks, including 48 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)
    Time Frame
    Value at 52 weeks minus value at baseline
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray
    Description
    Change from baseline in performance on the emotion recognition task (accuracy/reaction time) after a single dose of nasal spray Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.
    Time Frame
    Value at 30 minutes minus value at baseline
    Title
    Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray
    Description
    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 4 weeks of nasal spray. Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.
    Time Frame
    Value at 4 weeks minus value at baseline
    Title
    Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray)
    Description
    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 8 weeks (including 4 weeks without nasal spray). Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.
    Time Frame
    Value at 8 weeks minus value at baseline
    Title
    Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray)
    Description
    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 52 weeks (including 48 weeks without nasal spray) Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.
    Time Frame
    Value at 52 weeks minus value at baseline
    Title
    Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 4 Weeks of Nasal Spray
    Description
    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.
    Time Frame
    Value at 4 weeks minus value at baseline
    Title
    Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 8 Weeks, Including 4 Weeks Without Nasal Spray
    Description
    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.
    Time Frame
    Value at 8 weeks minus value at baseline
    Title
    Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 52 Weeks, Including 48 Weeks Without Nasal Spray
    Description
    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QOL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.
    Time Frame
    Value at 52 weeks minus value at baseline
    Title
    Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray
    Description
    Change from baseline in scores on one questionnaire assessing mood (Profile of Mood States - POMS) after a single dose of nasal spray. This instrument comprises emotional adjectives subdivided in five domains: tension (6 items). depression (8 items). vigor (5 items). fatigue (6 items) and anger (7 items) which have to be rated on a five-point Likert scale ranging from 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a lot), to 4 (extremely). Only for the vigor scale, higher scores indicate improvement.
    Time Frame
    Value at 30 minutes minus value at baseline

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Autism Spectrum Disorder, Asperger Syndrome or Autism Male Age between 18 and 40 years old Exclusion Criteria: Associated neuro(psycho)logical disorder (i.e. epilepsy, concussion, stroke) Eye sight worse than + or - 7 Genetic syndrome Color blindness Any contraindication to neuroimaging research as assessed with the MRI screening list: MRI contraindications: pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or implanted pump, a neurostimulator or VP shunt, any metallic object in the eyes (metallic fragments)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kaat Alaerts, PhD
    Organizational Affiliation
    KU Leuven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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