White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI

NCT ID: NCT04298866

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2023-06-04

Brief Summary

Cerebral small vessel diseases (SVD) are a very frequent group of disorders all characterized by alterations of the structure and/or function of small arteries, veins and capillaries. In these disorders, brain tissue lesions accumulate years before the occurrence of clinical symptoms which can be devastating such as stroke, cognitive disturbances and gait disorders. So far, chronic hypoperfusion was considered to be responsible for the accumulation of such lesions. However, recent results have suggested that the lesions underlying white matter hyperintensities (WMH), the most common MRI marker of SVD visible on conventional MRI in quite every subject with SVD long before the occurrence of clinical events, may depend on the considered brain area and may correspond to various mechanisms. Some WMH may even be associated with less severe clinical manifestations.The aim of the present study is to identify different types of WMH by studying 100 patients with different forms of SVD with the most advanced MRI (including ultra-high-resolution imaging at 7 Tesla, new diffusion protocol, sodium MRI, contrast-enhanced angiography and relaxometry and post-processing techniques), and post-processing techniques (machine learning, deep learning, artificial intelligence).

Conditions

Cerebral Small Vessel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental arm

Group Type: OTHER

Experimental Arm

Intervention Type: OTHER

• 3T MRI, maximum 1H30 long duration, including diffusion tensor imaging, susceptibility weighted imaging, multiparametric acquisitions, without contrast perfusion acquisitions.
• 7T MRI, maximum 1H30 long duration, including contrast enhanced acquisitions
• Neuropsychological battery including chronometric measures obtained through a computer interface

Interventions

Experimental Arm

• 3T MRI, maximum 1H30 long duration, including diffusion tensor imaging, susceptibility weighted imaging, multiparametric acquisitions, without contrast perfusion acquisitions.
• 7T MRI, maximum 1H30 long duration, including contrast enhanced acquisitions
• Neuropsychological battery including chronometric measures obtained through a computer interface

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects or patients with MRI defined cerebral small vessel disease including different extents of white matter hyperintensities, presumably related to hypertension (30 patients), cerebral amyloid angiopathy (30 patients), CADASIL (30 patients) or any other monogenic form of cerebral small vessel disease (HTRA1 AD, COLIVA1… 10 patients)
• Age ≥ 18 years
• No dementia (MMSE > 24 and absence of dependence in daily activities)
• No disability (modified Rankin's scale < 2)
• No history of severe allergic reaction, in particular to gadolinium infusion
• No history of severe asthma
• No renal insufficiency (clearance < 60 ml/mn/1.73 m2)

Exclusion Criteria

• Contraindications to MRI
• Standard MRI of bad quality due to movement artefacts
• Dementia or disability
• Patient without affiliation to the French social security

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Lariboisière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eric Jouvent, Pr

Role: CONTACT

eric.jouvent@aphp.fr

0149956529

Matthieu Resche-Rigon, Pr

Role: CONTACT

matthieu.resche-rigon@univ-paris-diderot.fr

0142499742 ext. 0142499742

Facility Contacts

Eric Jouvent, MD PhD

Role: primary

149956529 ext. +33

Other Identifiers

APHP180445

Identifier Type: -

Identifier Source: org_study_id