NCT02071784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

July 8, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2016

Completed
Last Updated

March 5, 2026

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

February 24, 2014

Last Update Submit

March 3, 2026

Conditions

CADASIL

Outcome Measures

Primary Outcomes (1)

  • model-derived parameters of neurovascular coupling

    one time point

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CENIR, Hopital Pitié Salpetriere

Paris, Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 30009197RESULT

MeSH Terms

Conditions

CADASIL

Condition Hierarchy (Ancestors)

Cerebral InfarctionBrain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesDementia, VascularCerebral Arterial DiseasesIntracranial Arterial DiseasesStrokeDementiaVascular DiseasesCardiovascular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Hugues Chabriat, MD PhD

    INSERM and APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

July 8, 2014

Primary Completion

October 24, 2016

Study Completion

October 24, 2016

Last Updated

March 5, 2026

Record last verified: 2021-08

Locations

FR(1)