Autistic DisorderNCT02444117
Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication in ASD
An observational study of Autistic Disorder, run by University Hospital, Tours at 1 site in France.
Trial summary
This study aims to identify clinical and biological markers which would allow to evaluate precisely the evolution of children with autism spectrum disorders throughout intervention. Read more about this study
- Who is it for?
- Ages 12 months to 12 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- functional rehabilitation of social communication
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Feb 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with autism spectrum disorders
Who may be able to join
- re-education of social communication
Who cannot join
- multi-handicapped associated to ASD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autism Spectrum Disorders: Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication
This study aims to identify clinical and biological markers which would allow to evaluate precisely the evolution of children with autism spectrum disorders throughout intervention.
Read the detailed description
200 children with autism spectrum disorders (1-12 years old) will be included in a 2 years follow-up study. Both clinical and neurophysiological evaluations (electrophysiological and eye tracking) will be completed at different times of the follow-up. This integrative approach, combining clinical and biological markers, will allow the identification of different developmental trajectories and then a better individuation of treatment in autism spectrum disorders.
- Conditions
- Autistic Disorder
- Being tested
- functional rehabilitation of social communication
- Keywords
- neurophysiology
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional rehabilitation of social communicationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical changes between Baseline and Two years
Autism Diagnostic Observation Schedule (ADOS)
Measured: 2 years
Secondary outcomes (9)
neurophysiological evaluations at baseline
Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices
Measured: baseline
neurophysiological evaluations at 1 year
Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices
Measured: 1 year
neurophysiological évaluations at 2 years
Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices
Measured: 2 years
Social and cognitive evaluations at baseline
Social and Cognitive Evaluation Battery (SCEB),
Measured: baseline
Social and cognitive évaluations at 1 year
Social and Cognitive Evaluation Battery (SCEB),
Measured: 1 year
Social and cognitive évaluations at 2 years
Social and Cognitive Evaluation Battery (SCEB),
Measured: 1 year
Repetitive behaviors évaluations at baseline
Repetitive and Restrictive Behavior Scale (RRBS)
Measured: baseline
Repetitive behaviors évaluations at one year
Repetitive and Restrictive Behavior Scale (RRBS)
Measured: 1 year
Repetitive behaviors at two years
Repetitive and Restrictive Behavior Scale (RRBS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joelle Malvy, MD, PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444117
- Sponsor's protocol ID
- 2013-A012740-45
- Status last verified
- Nov 2022
- First submitted
- 18 Feb 2015
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Khanna RK, Kovarski K, Arsene S, Siwiaszczyk M, Pisella PJ, Bonnet-Brilhault F, Batty M, Malvy J. Ophthalmological findings in children with autism spectrum disorder. Graefes Arch Clin Exp Ophthalmol. 2020 Apr;258(4):909-916. doi: 10.1007/s00417-019-04594-7. Epub 2020 Jan 9.
PubMed 31919663
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Spectrum Disorders: Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication
- ClinicalTrials.gov ID
- NCT02444117
- Acronym / sponsor ID
- 2013-A012740-45
- Conditions
- Autistic Disorder
- Keywords
- neurophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify clinical and biological markers which would allow to evaluate precisely the evolution of children with autism spectrum disorders throughout intervention.
Detailed description
200 children with autism spectrum disorders (1-12 years old) will be included in a 2 years follow-up study. Both clinical and neurophysiological evaluations (electrophysiological and eye tracking) will be completed at different times of the follow-up. This integrative approach, combining clinical and biological markers, will allow the identification of different developmental trajectories and then a better individuation of treatment in autism spectrum disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with autism spectrum disorders
Key inclusion criteria (1 listed)
- re-education of social communication
Key exclusion criteria (1 listed)
- multi-handicapped associated to ASD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional rehabilitation of social communication | Other | – |
Primary outcome
Clinical changes between Baseline and Two years
Time frame: 2 years
Autism Diagnostic Observation Schedule (ADOS)
9 secondary outcomes
neurophysiological evaluations at baseline
Time frame: baseline
neurophysiological evaluations at 1 year
Time frame: 1 year
neurophysiological évaluations at 2 years
Time frame: 2 years
Social and cognitive evaluations at baseline
Time frame: baseline
Social and cognitive évaluations at 1 year
Time frame: 1 year
Social and cognitive évaluations at 2 years
Time frame: 1 year
Repetitive behaviors évaluations at baseline
Time frame: baseline
Repetitive behaviors évaluations at one year
Time frame: 1 year
Repetitive behaviors at two years
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 31919663Khanna RK, Kovarski K, Arsene S, Siwiaszczyk M, Pisella PJ, Bonnet-Brilhault F, Batty M, Malvy J. Ophthalmological findings in children with autism spectrum disorder. Graefes Arch Clin Exp Ophthalmol. 2020 Apr;258(4):909-916. doi: 10.1007/s00417-019-04594-7. Epub 2020 Jan 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joelle Malvy, MD, PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical changes between Baseline and Two years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.