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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00012339 |
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Date of registration:
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20/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Volitional Modification of Brain Activity in ASD
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Scientific title:
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Volitional Modification of Brain Activity in ASD |
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Date of first enrolment:
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01/05/2017 |
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Target sample size:
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40 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00012339 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Lilian
Konicar |
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Address:
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Währinger Gürtel 18-20
1090
Wien
Austria |
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Telephone:
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0043 1 40 400 37460 |
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Email:
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lilian.konicar@meduniwien.ac.at |
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Affiliation:
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Medizinische Universität WienUniversitätsklinik für Kinder- & Jugendpsychiatrie |
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Name:
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Lilian
Konicar |
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Address:
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Währinger Gürtel 18-20
1090
Wien
Austria |
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Telephone:
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00431 40400 37460 |
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Email:
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lilian.konicar@meduniwien.ac.at |
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Affiliation:
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Medizinische Universität WienUniversitätsklinik für Kinder- & Jugendpsychiatrie |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Adolescents with autism spectrum disorder
- Age from 12.00 to 17.11 years, male and female
- IQ> 70, right-handed
- Informed Consent, ability to understand study information and instructions (sufficient knowledge of German), signed declarations of consent/assent of study participant and of parent/legal guardian
Exclusion criteria: - Severe neurological or medical diseases or severe head injuries
- Axis I diagnosis: Psychotic Disorder, Tic-, Tourette- or OC- Disorder, severe depression with suicidality
- Simultaneous participation in pharmacological study, former neurofeedback training
- Any implant or stainless steel graft or any other contraindications for MRI
- Failure to comply with the study protocol or to follow the instructions of the investigating team
Age minimum:
12 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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F84.1
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F84.5
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Atypical autism
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F84.5
F84.1
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Asperger syndrome
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Intervention(s)
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Group 1: Intervention1: 24 sessions Slow-Cortical-Potential Neurofeedback-Training during an app. 3-month intervention period (20 participants with ASD)
Group 2: Intervention 2: Treatment as Usual (TAU); Conventional treatment of the Department of Child- & Adolescence Psychiatry (20 participants with ASD)
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Primary Outcome(s)
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The primary endpoint of this study is the SCP (Slow-Cortical-Potential)-activity (SCP-differentiation in feedback and transfer condition, e.g. average µV-amplitude difference between required positivity and negativity) in the beginning of the training compared to the SCP-activity in the end of the training.
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Secondary Outcome(s)
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Secondary endpoints are the raw values ??of the questionnaires as well as the reaction times from psychological, computerised test from t0 (before the interventions) compared to t1 (after the interventions). Here, the target variables are autistic symptoms, comorbid characteristics, emotional processes, cognitive abilities and behavioral responses.
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Source(s) of Monetary Support
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FWF Der Wissenschaftsfonds
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Ethics review
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Status: Approved
Approval date: 05/11/2016
Contact:
Ethikkommission der Medizinischen Universität Wien [Ethik-Kommission der Medizinischen Universität Wien]
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