We aim to identify biomarkers (from neuroimaging, eye tracking, EEG, cognition, biochemistry, proteomics, genomics) for stratification of ASD. Biomarkers will be crucial to aid more accurate and earlier diagnosis of ASD. They are also needed for…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phenotyping of ASD will involve questionnaires and semi-structured interviews
probing the presence and severity of ASD. The MRI session includes structural
MRI, resting state, DTI and fMRI. Outside the scanner several computer based
tasks will be conducted to assess cognitive abilities. Eye-tracking and EEG
tasks will also be performed outside the scanner.
Secondary outcome
Not applicable
Background summary
Autism Spectrum Disorders (ASD) are a very heterogenous group of disorders
characterized by qualitative impairments in social interactions and
communication, and a range of repetitive and restricted behaviours and
interests. Clinical diagnosis is still based solely on behavioural
classification. No biomarkers have been established to aid in diagnosing or
stratifying ASD.
Study objective
We aim to identify biomarkers (from neuroimaging, eye tracking, EEG, cognition,
biochemistry, proteomics, genomics) for stratification of ASD. Biomarkers will
be crucial to aid more accurate and earlier diagnosis of ASD. They are also
needed for monitoring the effectiveness of new ASD treatments and for assessing
the developmental trajectory of the disorder.
Study design
The study will be carried out at six study sites across Europe (Institute of
Psychiatry, King*s College London (IoP / KCL), University of Cambridge (UCAM),
University Medical Centre Utrecht (UMCU), Radboud University Medical Centre
Nijmegen (RUNMC), Central Institute of Mental Health (CIMH, Germany),
Karolinska Institute, Stockholm (KI), University Compus Bio-Medico (Italy)).
Changes in ASD phenotype and biomarker profile will be assessed over time via
an accelerated longitudinally design involving baseline assessment and
follow-up at 12-24 months.
Study burden and risks
Children of 6-12 years will be included in this study, as we are investigating
the development of autistic behaviour in childhood, as well as adolescence and
adulthood. A study of young children through to adults is vital to
understanding how the clinical and biomarker profile of ASD changes at
different time points. Adolescent and adults with low IQ will be included as
about 40% of all individuals with ASD have low IQ, and these are strongly
underrepresented in all studies on ASD. By consequence, little is known about
the cognitive, neural and biomarkers correlates of ASD in persons with low IQ.
This work will lead to new biomarkers that will be essential for stratifying
ASD, guide development of new drug treatments, and monitor course and clinical
outcome.
Geert Grooteplein 21
Nijmegen 6500 HB
NL
Geert Grooteplein 21
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
ASD group:
(1) Males and females aged 6-30 years with an established diagnosis of Autism Spectrum Disorder according to DSM-IV; idiopathic and syndromic forms of ASD (e.g., Fragile X, Rett Syndrome) are allowed
(2) Males and females with IQ 50+
(3) All comorbidities (e.g., ADHD, anxiety) allowed except for psychosis and bipolar disorder
(4) Informed written consent;
(a) Where participants are their own legal guardian (i.e. aged 18 years and older without learning difficulties and demonstrated capacity to consent), written consent from the volunteer;
(b) Where participants are minors and/ or do not have capacity to consent, written informed consent from the parent or legal guardian; verbal assent from the volunteer prior to each assessment
(5) Availability of parent or caregiver who accompanies the volunteer to all institute visits and provides information about the volunteer*s behavior and symptoms. For adults with ASD who are their own legal guardian, availability of a parent who provides information about behavior/ symptoms during the institute visit, a separate home-visit or over the telephone.
(6) Participant on stable medication (min 8 weeks) at entrance point and over the course of study allowed
Typically Developing (TD) control group:
Males and females aged 6-30 years
Learning Difficulties (LD) control group:
Males and females aged 13-30 years
Syndromic forms of LD (Down*s Syndrome) and unspecified general learning disabilities allowed
Exclusion criteria
(1) Significant hearing or visual impairments not correctable by glasses or hearing aids
(2) Alcohol and / or substance abuse or dependence in the past year
(3) Any MRI counter-indications (e.g., metal implants, braces)
ASD and LD group: presence of psychosis or bipolar disorder
TD group: presence of any DSM-V axis I and II psychiatric disorders
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45500.091.13 |