Attention Deficit-HyperactivityTDAHNCT03546010
Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition
A study testing Neuropsychological tests and Oculometric tests in people with Attention Deficit-Hyperactivity, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this study is to analyse thanks to eye tracking experiments ocular movement classical parameters in children with attention deficit hyperactivity (ADH) and to compare them to results obtained in healthy children and to results obtained with neuropsychological tests commonly used in standard health care. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Attention Deficit-Hyperactivity
- What is being tested?
- Neuropsychological tests and Oculometric tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2014to 31 Dec 2018
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 8 and 12 years old
- Boys and girls
- DSM-IV-TR diagnostic criteria for ADH
- Children with methylprednisone treatment
- Social security affiliation
- signed informed consent
Who cannot join
- specialised scholarship
- refusal from children or parents
- too law results in WISC test (pre-inclusion test)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble Alps Hospital
Grenoble
Annie Laurent, MD
About this study
The aim of this study is to analyse thanks to eye tracking experiments ocular movement classical parameters in children with attention deficit hyperactivity (ADH) and to compare them to results obtained in healthy children and to results obtained with neuropsychological tests commonly used in standard health care.
We should then be able to compare eye tracking with neuropsychological parameters.
The final objective is to give to health professional a tool for ADH investigation with which they should be able to do a simple and effective follow up of children with ADH.
- Conditions
- Attention Deficit-Hyperactivity
- Being tested
- Neuropsychological tests, Oculometric tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsBehavioural
WISC test, BRIEF test, NEPSY-2 test, TAP2.3 test, Teach test
Oculometric testsBehavioural
When the subject see a peripheric target, he should take a look not at the target but in the controlateral half-field, at a mirror position. This is called an anti-saccade task.
| Study group | Role | What they receive |
|---|---|---|
| Oculometric and neuropsychological tests | Experimental | Oculometric tests and neuropsychological tests Receives: Behavioral: Neuropsychological tests; Behavioral: Oculometric tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between oculometric and neuropsychological tests in ADH evaluation
Differentiation between simple oculomotor disorder and attentional-visual disorder
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start5 May 2014
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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 Attention Deficit-HyperactivityStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annie Laurent, MD, Principal investigator, Grenoble Alps University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546010
- Sponsor's protocol ID
- 38RC14.100
- Acronym
- TDAH
- Status last verified
- Jun 2018
- First submitted
- 18 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malsert J, Guyader N, Chauvin A, Polosan M, Szekely D, Bougerol T, Marendaz C. Saccadic performance and cortical excitability as trait-markers and state-markers in rapid cycling bipolar disorder: a two-case follow-up study. Front Psychiatry. 2013 Jan 4;3:112. doi: 10.3389/fpsyt.2012.00112. eCollection 2012.
PubMed 23293609
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition
- ClinicalTrials.gov ID
- NCT03546010
- Acronym / sponsor ID
- TDAH / 38RC14.100
- Conditions
- Attention Deficit-Hyperactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 6 Jun 2018 (actual)
- 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 aim of this study is to analyse thanks to eye tracking experiments ocular movement classical parameters in children with attention deficit hyperactivity (ADH) and to compare them to results obtained in healthy children and to results obtained with neuropsychological tests commonly used in standard health care.
We should then be able to compare eye tracking with neuropsychological parameters.
The final objective is to give to health professional a tool for ADH investigation with which they should be able to do a simple and effective follow up of children with ADH.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oculometric and neuropsychological tests | Experimental | Behavioral: Neuropsychological tests, Behavioral: Oculometric testsOculometric tests and neuropsychological tests |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children between 8 and 12 years old
- Boys and girls
- DSM-IV-TR diagnostic criteria for ADH
- Children with methylprednisone treatment
- Social security affiliation
Key exclusion criteria (3 listed)
- specialised scholarship
- refusal from children or parents
- too law results in WISC test (pre-inclusion test)
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 |
|---|---|---|
| Neuropsychological testsWISC test, BRIEF test, NEPSY-2 test, TAP2.3 test, Teach test | Behavioural | Oculometric and neuropsychological tests |
| Oculometric testsWhen the subject see a peripheric target, he should take a look not at the target but in the controlateral half-field, at a mirror position. This is called an anti-saccade task. | Behavioural | Oculometric and neuropsychological tests |
Primary outcome
Correlation between oculometric and neuropsychological tests in ADH evaluation
Time frame: Day 1
Differentiation between simple oculomotor disorder and attentional-visual disorder
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Background: PubMed 23293609Malsert J, Guyader N, Chauvin A, Polosan M, Szekely D, Bougerol T, Marendaz C. Saccadic performance and cortical excitability as trait-markers and state-markers in rapid cycling bipolar disorder: a two-case follow-up study. Front Psychiatry. 2013 Jan 4;3:112. doi: 10.3389/fpsyt.2012.00112. eCollection 2012.
- Individual participant dataSharing planned: No
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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.
Annie Laurent, MD principal investigator
Grenoble Alps University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological tests and Oculometric tests in people with Attention Deficit-Hyperactivity, run by University Hospital, Grenoble 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 6 inclusion and 3 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 6 Jun 2018. 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 Annie Laurent, MD (04 76 76 54 19, AnnieLaurent@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between oculometric and neuropsychological tests in ADH evaluation (time frame: Day 1). 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 NCT03546010, 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 6 Jun 2018.