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

NCT04298866 | Unknown

• 1 other identifier: APHP180445
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a different form of white matter hyperintensities (WMH)

  The different forms of white matter hyperintensities will be assessed and identified using MRI imaging.The pattern of co-variation of structural, functional, metabolic imaging modalities, estimated in each voxel of a reference space, both inside and outside the WMH, will be compared through massive statistical approaches, controlled, for multiple testing

  at the time of specific imaging (between Day 1 to Day 60)

Secondary Outcomes (14)

• Frequency of different WMH subtypes in different types of small cerebral vessel disease

  at the time of specific imaging (between Day 1 to Day 60)

• Frequency of large tract involvement

  at the time of specific imaging (between Day 1 to Day 60)

• Global cognitive function

  at inclusion

• Language

  at inclusion

• Spatial exploration

  at inclusion

Study Arms (1)

Experimental arm

OTHER

Other: Experimental Arm

Interventions

Experimental Arm 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

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Lariboisière

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Eric Jouvent, Pr

CONTACT

0149956529; eric.jouvent@aphp.fr

Matthieu Resche-Rigon, Pr

CONTACT

0142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 6, 2020
• Study Start: March 4, 2021
• Primary Completion: June 4, 2023
• Study Completion: June 4, 2023
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

FR (1)