White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI (SV7)
Primary Purpose
Cerebral Small Vessel Diseases
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental Arm
Sponsored by
About this trial
This is an interventional other trial for Cerebral Small Vessel Diseases
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
Sites / Locations
- Hopital LariboisièreRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Experimental arm
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Frequency of different WMH subtypes in different types of small cerebral vessel disease
Distribution of white matter hyperintensities in different brain areas according to the small cerebral vessel disease
Frequency of large tract involvement
Large tratreconstructed from diffusion imaging) by WMH depending on the the small cerebral vessel disease
Global cognitive function
The global cognitive functions will be assessed using MOCA. The MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation to time and place
Language
Language assessment will be done using LAST and Boston Naming Test
Spatial exploration
The neglect and spatial exploration will be assessed with bells test from the BEN neglect battery
Spatial memory
Spatial memory will be assessed using the brief visual-spatial memory test (BVMT-R)
Visual memory
Visual memory will be assessed using the brief visual-spatial memory test (BVMT-R)
Episodic verbal memory
Episodic verbal memory test by the RL RI 16
Working memory
Working memory will be evaluated by the working memory index of the WAIS-IV
Executive function
Executive function will be assessed by the versions A and B of the Trail Making Test
Attentional Performances status
Attentional Performances will be assessed using a battery on a computer which tests different attentionnal and executive function
Depression and Anxiety status
Depression and anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.
HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).
Apathy status
Apathy status will be assessed using the Starkstein scale
Pulse wave Velocity count
Arterial stifness will be assessed by measuring the pulse wave velocity
Full Information
NCT ID
NCT04298866
First Posted
February 26, 2020
Last Updated
April 30, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04298866
Brief Title
White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI
Acronym
SV7
Official Title
White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
June 4, 2023 (Anticipated)
Study Completion Date
June 4, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Small Vessel Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Experimental Arm
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of patients with a different form of white matter hyperintensities (WMH)
Description
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
Time Frame
at the time of specific imaging (between Day 1 to Day 60)
Secondary Outcome Measure Information:
Title
Frequency of different WMH subtypes in different types of small cerebral vessel disease
Description
Distribution of white matter hyperintensities in different brain areas according to the small cerebral vessel disease
Time Frame
at the time of specific imaging (between Day 1 to Day 60)
Title
Frequency of large tract involvement
Description
Large tratreconstructed from diffusion imaging) by WMH depending on the the small cerebral vessel disease
Time Frame
at the time of specific imaging (between Day 1 to Day 60)
Title
Global cognitive function
Description
The global cognitive functions will be assessed using MOCA. The MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation to time and place
Time Frame
at inclusion
Title
Language
Description
Language assessment will be done using LAST and Boston Naming Test
Time Frame
at inclusion
Title
Spatial exploration
Description
The neglect and spatial exploration will be assessed with bells test from the BEN neglect battery
Time Frame
at inclusion
Title
Spatial memory
Description
Spatial memory will be assessed using the brief visual-spatial memory test (BVMT-R)
Time Frame
at inclusion
Title
Visual memory
Description
Visual memory will be assessed using the brief visual-spatial memory test (BVMT-R)
Time Frame
at inclusion
Title
Episodic verbal memory
Description
Episodic verbal memory test by the RL RI 16
Time Frame
at inclusion
Title
Working memory
Description
Working memory will be evaluated by the working memory index of the WAIS-IV
Time Frame
at inclusion
Title
Executive function
Description
Executive function will be assessed by the versions A and B of the Trail Making Test
Time Frame
at inclusion
Title
Attentional Performances status
Description
Attentional Performances will be assessed using a battery on a computer which tests different attentionnal and executive function
Time Frame
at inclusion
Title
Depression and Anxiety status
Description
Depression and anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.
HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).
Time Frame
at inclusion
Title
Apathy status
Description
Apathy status will be assessed using the Starkstein scale
Time Frame
at inclusion
Title
Pulse wave Velocity count
Description
Arterial stifness will be assessed by measuring the pulse wave velocity
Time Frame
at inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Jouvent, Pr
Phone
0149956529
Email
eric.jouvent@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu Resche-Rigon, Pr
Phone
0142499742
Ext
0142499742
Email
matthieu.resche-rigon@univ-paris-diderot.fr
Facility Information:
Facility Name
Hopital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Jouvent, MD PhD
Phone
149956529
Ext
+33
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI
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