CADASILMACOUPLING-CADNCT02071784
Imaging Study of Neurovascular Coupling in Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)
An observational study of CADASIL, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical models, the potential alterations of neurovascular coupling in CADASIL. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- CADASIL
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2014to 24 Oct 2016
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: CADASIL patients compared to age-matched controls (two groups)
Who may be able to join
- CADASIL group: typical NOTCH3 mutation, age less than 60 years, rankin score at 0-1, active social insurance
Who cannot join
- MRI contra-indications and use of any treatment known to interfere with neurovascular coupling, pregnancy, lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude Comparative en Imagerie Par résonnance magnétique et Par Enregistrement électroencéphalographique du Couplage Neurovasculaire Dans l'Angiopathie Cadasil
The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical models, the potential alterations of neurovascular coupling in CADASIL.
Read the detailed description
Comparison study of parameters derived from mathematical models of neurovascular coupling and obtained using fMRI (Bold signal, ASL and EEG).
- Conditions
- CADASIL
- Medical subject headings
- CADASIL
What is being measured
The primary outcome is the main question the study is designed to answer.
model-derived parameters of neurovascular coupling
Measured: one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study start8 Jul 2014
- Primary completion24 Oct 2016
- Study completion24 Oct 2016
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 CADASILStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hugues Chabriat, MD PhD, Principal investigator, INSERM and APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071784
- Sponsor's protocol ID
- C13-62
- Other IDs
- 2014-A00200-47
- Acronym
- MACOUPLING-CAD
- Status last verified
- Aug 2021
- First submitted
- 24 Feb 2014
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Huneau C, Houot M, Joutel A, Beranger B, Giroux C, Benali H, Chabriat H. Altered dynamics of neurovascular coupling in CADASIL. Ann Clin Transl Neurol. 2018 May 21;5(7):788-802. doi: 10.1002/acn3.574. eCollection 2018 Jul.
PubMed 30009197
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Comparative en Imagerie Par résonnance magnétique et Par Enregistrement électroencéphalographique du Couplage Neurovasculaire Dans l'Angiopathie Cadasil
- ClinicalTrials.gov ID
- NCT02071784
- Acronym / sponsor ID
- MACOUPLING-CAD / C13-62
- Conditions
- CADASIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 8 Jul 2014 (actual)
- Primary completion
- 24 Oct 2016 (actual)
- Study completion
- 24 Oct 2016 (actual)
- First posted
- 26 Feb 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 aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical models, the potential alterations of neurovascular coupling in CADASIL.
Detailed description
Comparison study of parameters derived from mathematical models of neurovascular coupling and obtained using fMRI (Bold signal, ASL and EEG).
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- CADASIL patients compared to age-matched controls (two groups)
Key inclusion criteria (1 listed)
- CADASIL group: typical NOTCH3 mutation, age less than 60 years, rankin score at 0-1, active social insurance
Key exclusion criteria (1 listed)
- MRI contra-indications and use of any treatment known to interfere with neurovascular coupling, pregnancy, lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
model-derived parameters of neurovascular coupling
Time frame: one time point
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 5 Mar 2026.
- Results publication: PubMed 30009197Huneau C, Houot M, Joutel A, Beranger B, Giroux C, Benali H, Chabriat H. Altered dynamics of neurovascular coupling in CADASIL. Ann Clin Transl Neurol. 2018 May 21;5(7):788-802. doi: 10.1002/acn3.574. eCollection 2018 Jul.
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RecruitingObservational study
Registry for CADASIL
Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy
RecruitingObservational study
Natural History Study of CADASIL
Cardiovascular Disease, Arterial Stiffness
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The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up.
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Florida Cerebrovascular Disease Biorepository and Genomics Center
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Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
Cerebral Amyloid Angiopathy, CAA - Cerebral Amyloid Angiopathy
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.
Hugues Chabriat, MD PhD principal investigator
INSERM and APHP
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 CADASIL, run by Institut National de la Santé Et de la Recherche Médicale, France 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 5 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?
model-derived parameters of neurovascular coupling (time frame: one time point). 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 NCT02071784, 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 5 Mar 2026.