Agenesis of the Corpus CallosumDACCINCT02267161
Infants With Agenesis of the Corpus Callosum
A study testing Psychometric scales for infants at 3 years of age in people with Agenesis of the Corpus Callosum, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Agenesis of the Corpus Callosum
- What is being tested?
- Psychometric scales for infants at 3 years of age
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2015to 11 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women from 28 weeks of gestation
- Complete agenesis of the corpus callosum
- Partial agenesis of the corpus callosum
- Abnormal corpus callosum (size, anatomy) As diagnosed by an expert ultrasound fetal brain examination.
Who cannot join
- age < 18 years old
- women who do not understand french
- women not covered by the French social security system
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Infants With Prenatal Corpus Callosum Agenesis
The purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Read the detailed description
Agenesis of the corpus callosum is the most frequent brain malformation. This anomaly may be diagnosed by ultrasound screening. In half of these prenatal cases, the anomaly seems to be isolated. In this setting, there are no prospective data concerning the development of these children, preventing any clear information to be delivered to parents. Prenatal diagnostic centers therefore face extremely variable rates of termination of pregnancies (TOP), which can reach up to 80%.
This is a multicentric prospective interventional study whose primary objective is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Evaluation at three years will include Intellectual Quotient (IQ) quantification using the WPPSI-III, 3rd edition of Wechsler Preschool and Primary Scale of Intelligence and evaluation of intra-hemispheric coordination using the Vineland adaptative behaviour scale.
Secondary objectives will include:
- Circumstances leading to the prenatal diagnosis of agenesis of the corpus callosum
- Causes leading to termination of pregnancies
- Determination of criteria allowing to confirm that agenesis of the corpus callosum is isolated (family history, imagery, genetics)
These results could allow to determine the optimal prenatal management of such cases.
- Conditions
- Agenesis of the Corpus Callosum
- Being tested
- Psychometric scales for infants at 3 years of age
- Keywords
- agenesis, corpus callosum, prenatal diagnosis
- Medical subject headings
- Agenesis of Corpus Callosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric scales for infants at 3 years of ageOther
WPPSI-III, VINELAND, CBCL, NEPSY
| Study group | Role | What they receive |
|---|---|---|
| neuropsycological tests | Experimental | Psychometric scales for infants at 3 years of age Receives: Other: Psychometric scales for infants at 3 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)
Neurodevelopment outcome
Measured: 3 years
Secondary outcomes (4)
Vineland adaptative behaviour scales (motricity capacity) : questionnaire
Neurodevelopment outcome
Measured: 3 years
Nepsy : developmental neuropsychological assessment (capacity of coordination)
Neurodevelopment outcome
Measured: 3 years
CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire
Neurodevelopment outcome
Measured: 3 years
Cerebral abnormalities
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start26 Sep 2015
- Primary completion1 Oct 2020
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Agenesis of the Corpus CallosumStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Jouannic, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267161
- Sponsor's protocol ID
- K151004
- Other IDs
- 2014-A00625-42
- Acronym
- DACCI
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2014
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Sotiriadis A, Makrydimas G. Neurodevelopment after prenatal diagnosis of isolated agenesis of the corpus callosum: an integrative review. Am J Obstet Gynecol. 2012 Apr;206(4):337.e1-5. doi: 10.1016/j.ajog.2011.12.024. Epub 2011 Dec 27.
PubMed 22284958Moutard ML, Kieffer V, Feingold J, Lewin F, Baron JM, Adamsbaum C, Gelot A, Isapof A, Kieffer F, de Villemeur TB. Isolated corpus callosum agenesis: a ten-year follow-up after prenatal diagnosis (how are the children without corpus callosum at 10 years of age?). Prenat Diagn. 2012 Mar;32(3):277-83. doi: 10.1002/pd.3824.
PubMed 22430728Moutard ML, Kieffer V, Feingold J, Kieffer F, Lewin F, Adamsbaum C, Gelot A, Campistol I Plana J, van Bogaert P, Andre M, Ponsot G. Agenesis of corpus callosum: prenatal diagnosis and prognosis. Childs Nerv Syst. 2003 Aug;19(7-8):471-6. doi: 10.1007/s00381-003-0781-6. Epub 2003 Jul 4.
PubMed 12845459
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Infants With Prenatal Corpus Callosum Agenesis
- ClinicalTrials.gov ID
- NCT02267161
- Acronym / sponsor ID
- DACCI / K151004
- Conditions
- Agenesis of the Corpus Callosum
- Keywords
- agenesis, corpus callosum, prenatal diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 26 Sep 2015 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 17 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 purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Detailed description
Agenesis of the corpus callosum is the most frequent brain malformation. This anomaly may be diagnosed by ultrasound screening. In half of these prenatal cases, the anomaly seems to be isolated. In this setting, there are no prospective data concerning the development of these children, preventing any clear information to be delivered to parents. Prenatal diagnostic centers therefore face extremely variable rates of termination of pregnancies (TOP), which can reach up to 80%.
This is a multicentric prospective interventional study whose primary objective is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Evaluation at three years will include Intellectual Quotient (IQ) quantification using the WPPSI-III, 3rd edition of Wechsler Preschool and Primary Scale of Intelligence and evaluation of intra-hemispheric coordination using the Vineland adaptative behaviour scale.
Secondary objectives will include:
- Circumstances leading to the prenatal diagnosis of agenesis of the corpus callosum
- Causes leading to termination of pregnancies
- Determination of criteria allowing to confirm that agenesis of the corpus callosum is isolated (family history, imagery, genetics)
These results could allow to determine the optimal prenatal management of such cases.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuropsycological tests | Experimental | Other: Psychometric scales for infants at 3 years of agePsychometric scales for infants at 3 years of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women from 28 weeks of gestation
- Complete agenesis of the corpus callosum
- Partial agenesis of the corpus callosum
- Abnormal corpus callosum (size, anatomy) As diagnosed by an expert ultrasound fetal brain examination.
Key exclusion criteria (4 listed)
- age < 18 years old
- women who do not understand french
- women not covered by the French social security system
- refusal to participate
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 |
|---|---|---|
| Psychometric scales for infants at 3 years of ageWPPSI-III, VINELAND, CBCL, NEPSY | Other | neuropsycological tests |
Primary outcome
WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)
Time frame: 3 years
Neurodevelopment outcome
4 secondary outcomes
Vineland adaptative behaviour scales (motricity capacity) : questionnaire
Time frame: 3 years
Nepsy : developmental neuropsychological assessment (capacity of coordination)
Time frame: 3 years
CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire
Time frame: 3 years
Cerebral abnormalities
Time frame: up to 3 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 31 Mar 2026.
- Background: PubMed 22284958Sotiriadis A, Makrydimas G. Neurodevelopment after prenatal diagnosis of isolated agenesis of the corpus callosum: an integrative review. Am J Obstet Gynecol. 2012 Apr;206(4):337.e1-5. doi: 10.1016/j.ajog.2011.12.024. Epub 2011 Dec 27.
- Background: PubMed 22430728Moutard ML, Kieffer V, Feingold J, Lewin F, Baron JM, Adamsbaum C, Gelot A, Isapof A, Kieffer F, de Villemeur TB. Isolated corpus callosum agenesis: a ten-year follow-up after prenatal diagnosis (how are the children without corpus callosum at 10 years of age?). Prenat Diagn. 2012 Mar;32(3):277-83. doi: 10.1002/pd.3824.
- Background: PubMed 12845459Moutard ML, Kieffer V, Feingold J, Kieffer F, Lewin F, Adamsbaum C, Gelot A, Campistol I Plana J, van Bogaert P, Andre M, Ponsot G. Agenesis of corpus callosum: prenatal diagnosis and prognosis. Childs Nerv Syst. 2003 Aug;19(7-8):471-6. doi: 10.1007/s00381-003-0781-6. Epub 2003 Jul 4.
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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-Marie Jouannic, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychometric scales for infants at 3 years of age in people with Agenesis of the Corpus Callosum, run by Assistance Publique - Hôpitaux de Paris 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 4 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 31 Mar 2026. 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?
WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire) (time frame: 3 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 NCT02267161, which also lists 3 linked publications.
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 Mar 2026.