Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 4 of 9 for:    CADASIL

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT02071784
First received: February 24, 2014
Last updated: February 27, 2014
Last verified: February 2014
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071784

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

No publications provided

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
Study First Received: February 24, 2014
Last Updated: February 27, 2014
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
CADASIL
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebral Arterial Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Dementia
Dementia, Vascular
Genetic Diseases, Inborn
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015