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

This study is currently recruiting participants.
Verified February 2016 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT02071784
First Posted: February 26, 2014
Last Update Posted: February 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
  Purpose
The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical models, the potential alterations of neurovascular coupling in CADASIL.

Condition
CADASIL

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Etude Comparative en Imagerie Par résonnance magnétique et Par Enregistrement électroencéphalographique du Couplage Neurovasculaire Dans l'Angiopathie Cadasil

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • model-derived parameters of neurovascular coupling [ Time Frame: one time point ]

Estimated Enrollment: 60
Study Start Date: January 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Detailed Description:
Comparison study of parameters derived from mathematical models of neurovascular coupling and obtained using fMRI (Bold signal, ASL and EEG).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
CADASIL patients compared to age-matched controls (two groups)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071784


Locations
France
CENIR, Hopital Pitié Salpetriere Recruiting
Paris, France, 75013
Contact: Hugues CHABRIAT       hugues.chabriat@lrb.aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Hugues Chabriat, MD PhD INSERM and APHP
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02071784     History of Changes
Other Study ID Numbers: C13-62
2014-A00200-47 ( Registry Identifier: IDRCB )
First Submitted: February 24, 2014
First Posted: February 26, 2014
Last Update Posted: February 24, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
CADASIL
Dementia, Multi-Infarct
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia, Vascular
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Dementia
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn
Cerebral Infarction
Brain Infarction
Brain Ischemia
Stroke
Neurocognitive Disorders
Mental Disorders