Imaging Study of Neurovascular Coupling in Cerebral Autos... | NCT02071784

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

NCT02071784

Sponsor

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

Status

Completed

Last Update Posted

Mar 5, 2026Actual

Enrollment

60Actual

Phase

Not provided

Conditions

CADASIL

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-A00200-47	Registry Identifier	IDRCB

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2014Actual

Primary Completion Date

Oct 24, 2016Actual

Completion Date

Oct 24, 2016Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Feb 25, 2014

First Posted Date

Feb 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugues Chabriat, MD PhD	INSERM and APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CENIR, Hopital Pitié Salpetriere		Paris	Paris	75013	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30009197	Result	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.

ID	Term
D002544	Cerebral Infarction
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders