Autistic DisorderMEM-T2ANCT02279680
Associative Memory in Adults With an Autism Spectrum Disorder
A study testing Electroencephalography and Neuropsychological assesments in people with Autistic Disorder, run by University Hospital, Caen at 1 site in France.
Trial summary
The objective of this multidisciplinary project is to explore the deficit of associative memory in ASD (Autistic Spectrum Disorder) that could result from abnormal brain connectivity. The hypothesis of abnormal functioning of the fronto-hippocampal network has been evocated but has never been tested. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Electroencephalography and Neuropsychological assesments
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2016
- Phase
- Interventional
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult between 18 and 30 years old
- right handed
- affiliated to the french national health care system
- ASD only for the group of patients
Who cannot join
- mental retardation
- schizophrenia
- ADHD
- brain injury with lost of consciousness
- neurological disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UMR1077 Inserm/EPHE/UCBN
Caen, Caen, 14000
Bérengère GUILLERY-GIRARD, 0231064347, berengere.guillery@unicaen.fr
Pierre DESAUNAY
About this study
Official title: The Associative Memory in Autism Spectrum Disorders Without Intellectual Disability
The objective of this multidisciplinary project is to explore the deficit of associative memory in ASD (Autistic Spectrum Disorder) that could result from abnormal brain connectivity. The hypothesis of abnormal functioning of the fronto-hippocampal network has been evocated but has never been tested. Hence, the present project will include two complementary assessments conducted on a group of adults aged from 18 to 30 with ASD compared to a control group matched in chronological age and intellectual quotient. The first assessment is devoted to the study of associative memory and its EEG correlates and the second focused on the investigation of perceptual strategies related to associative memory using the technique of Eye-tracking. Both behavioral and imaging data would provide new insights on the relationship between perception and memory in ASD.
- Conditions
- Autistic Disorder
- Being tested
- Electroencephalography, Neuropsychological assesments
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDevice
Neuropsychological assesmentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Adults between 18 and 30 years old right handing Patients with ASD Receives: Device: Electroencephalography; Behavioral: Neuropsychological assesments |
| Healthy volunteers | Other | Adults between 18 and 30 years old Right handing Healthy Receives: Device: Electroencephalography; Behavioral: Neuropsychological assesments |
What is being measured
The primary outcome is the main question the study is designed to answer.
The associative memory index
Measured: 2 years
Secondary outcomes (1)
theta and gamma oscillations during the associative memory task
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 posted31 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc BALEYTE, PU-PH, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279680
- Sponsor's protocol ID
- 2013-AO1800-45
- Acronym
- MEM-T2A
- Status last verified
- Oct 2014
- First submitted
- 23 Jun 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Associative Memory in Autism Spectrum Disorders Without Intellectual Disability
- ClinicalTrials.gov ID
- NCT02279680
- Acronym / sponsor ID
- MEM-T2A / 2013-AO1800-45
- Conditions
- Autistic Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Oct 2014 (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.
The objective of this multidisciplinary project is to explore the deficit of associative memory in ASD (Autistic Spectrum Disorder) that could result from abnormal brain connectivity. The hypothesis of abnormal functioning of the fronto-hippocampal network has been evocated but has never been tested. Hence, the present project will include two complementary assessments conducted on a group of adults aged from 18 to 30 with ASD compared to a control group matched in chronological age and intellectual quotient. The first assessment is devoted to the study of associative memory and its EEG correlates and the second focused on the investigation of perceptual strategies related to associative memory using the technique of Eye-tracking. Both behavioral and imaging data would provide new insights on the relationship between perception and memory in ASD.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Device: Electroencephalography, Behavioral: Neuropsychological assesmentsAdults between 18 and 30 years old right handing Patients with ASD |
| Healthy volunteers | Other | Device: Electroencephalography, Behavioral: Neuropsychological assesmentsAdults between 18 and 30 years old Right handing Healthy |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult between 18 and 30 years old
- right handed
- affiliated to the french national health care system
- ASD only for the group of patients
Key exclusion criteria (5 listed)
- mental retardation
- schizophrenia
- ADHD
- brain injury with lost of consciousness
- neurological disease
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 |
|---|---|---|
| Electroencephalography | Device | Healthy volunteers, Patients |
| Neuropsychological assesments | Behavioural | Healthy volunteers, Patients |
Primary outcome
The associative memory index
Time frame: 2 years
1 secondary outcome
theta and gamma oscillations during the associative memory task
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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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.
Jean-Marc BALEYTE, PU-PH principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography and Neuropsychological assesments in people with Autistic Disorder, run by University Hospital, Caen 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Oct 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bérengère GUILLERY-GIRARD, MCU (0231064347, berengere.guillery@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The associative memory index (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2014.