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

Cerebral Small Vessel Diseases Clinical Trial

— SV7  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04298866
• Other study ID #: APHP180445
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: June 4, 2023

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Eric Jouvent, Pr
• Phone: 0149956529
• Email: eric.jouvent[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 4, 2023
• Est. primary completion date: June 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Hopital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at the time of specific imaging (between Day 1 to Day 60)
Secondary	Frequency of large tract involvement	Large tratreconstructed from diffusion imaging) by WMH depending on the the small cerebral vessel disease	at the time of specific imaging (between Day 1 to Day 60)
Secondary	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	at inclusion
Secondary	Language	Language assessment will be done using LAST and Boston Naming Test	at inclusion
Secondary	Spatial exploration	The neglect and spatial exploration will be assessed with bells test from the BEN neglect battery	at inclusion
Secondary	Spatial memory	Spatial memory will be assessed using the brief visual-spatial memory test (BVMT-R)	at inclusion
Secondary	Visual memory	Visual memory will be assessed using the brief visual-spatial memory test (BVMT-R)	at inclusion
Secondary	Episodic verbal memory	Episodic verbal memory test by the RL RI 16	at inclusion
Secondary	Working memory	Working memory will be evaluated by the working memory index of the WAIS-IV	at inclusion
Secondary	Executive function	Executive function will be assessed by the versions A and B of the Trail Making Test	at inclusion
Secondary	Attentional Performances status	Attentional Performances will be assessed using a battery on a computer which tests different attentionnal and executive function	at inclusion
Secondary	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).	at inclusion
Secondary	Apathy status	Apathy status will be assessed using the Starkstein scale	at inclusion
Secondary	Pulse wave Velocity count	Arterial stifness will be assessed by measuring the pulse wave velocity	at inclusion