Imaging Study of Neurovascular Coupling in Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL) (MACOUPLING-CAD)

August 24, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Comparison study of parameters derived from mathematical models of neurovascular coupling and obtained using fMRI (Bold signal, ASL and EEG).

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • CENIR, Hopital Pitié Salpetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

CADASIL patients compared to age-matched controls (two groups)

Description

Inclusion Criteria:

  • CADASIL group: typical NOTCH3 mutation, age less than 60 years, rankin score at 0-1, active social insurance

Exclusion Criteria:

  • MRI contra-indications and use of any treatment known to interfere with neurovascular coupling, pregnancy, lack of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
model-derived parameters of neurovascular coupling
Time Frame: one time point
one time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Hugues Chabriat, MD PhD, INSERM and APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2014

Primary Completion (Actual)

October 24, 2016

Study Completion (Actual)

October 24, 2016

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C13-62
  • 2014-A00200-47 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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