Cerebral Small Vessel DiseasesSV7NCT04298866
White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI
A study testing Experimental Arm in people with Cerebral Small Vessel Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Diseases
- What is being tested?
- Experimental Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2021to 4 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Contraindications to MRI
- Standard MRI of bad quality due to movement artefacts
- Dementia or disability
- Patient without affiliation to the French social security
Trial locations and contacts
1 site in 1 country.
Matthieu Resche-Rigon, Pr contact
France1 site, 1 recruiting
- Recruiting
Hopital Lariboisière
Paris, 75010
Eric Jouvent, MD PhD, 149956529 ext. +33
About this study
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
- Being tested
- Experimental Arm
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ArmOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Other | Not described Receives: Other: Experimental Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Distribution of white matter hyperintensities in different brain areas according to the small cerebral vessel disease
Measured: at the time of specific imaging (between Day 1 to Day 60)
Frequency of large tract involvement
Large tratreconstructed from diffusion imaging) by WMH depending on the the small cerebral vessel disease
Measured: at the time of specific imaging (between Day 1 to Day 60)
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
Measured: at inclusion
Language
Language assessment will be done using LAST and Boston Naming Test
Measured: at inclusion
Spatial exploration
The neglect and spatial exploration will be assessed with bells test from the BEN neglect battery
Measured: at inclusion
Spatial memory
Spatial memory will be assessed using the brief visual-spatial memory test (BVMT-R)
Measured: at inclusion
Visual memory
Visual memory will be assessed using the brief visual-spatial memory test (BVMT-R)
Measured: at inclusion
Episodic verbal memory
Episodic verbal memory test by the RL RI 16
Measured: at inclusion
Working memory
Working memory will be evaluated by the working memory index of the WAIS-IV
Measured: at inclusion
Executive function
Executive function will be assessed by the versions A and B of the Trail Making Test
Measured: at inclusion
Attentional Performances status
Attentional Performances will be assessed using a battery on a computer which tests different attentionnal and executive function
Measured: at inclusion
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).
Measured: at inclusion
Apathy status
Apathy status will be assessed using the Starkstein scale
Measured: at inclusion
Pulse wave Velocity count
Arterial stifness will be assessed by measuring the pulse wave velocity
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start4 Mar 2021
- Primary completion4 Jun 2023 (estimated)
- Study completion4 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298866
- Sponsor's protocol ID
- APHP180445
- Acronym
- SV7
- Status last verified
- Apr 2021
- First submitted
- 26 Feb 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI
- ClinicalTrials.gov ID
- NCT04298866
- Acronym / sponsor ID
- SV7 / APHP180445
- Conditions
- Cerebral Small Vessel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 4 Jun 2023 (estimated)
- Study completion
- 4 Jun 2023 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Other | Other: Experimental Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Contraindications to MRI
- Standard MRI of bad quality due to movement artefacts
- Dementia or disability
- Patient without affiliation to the French social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Experimental arm |
Primary outcome
Percentage of patients with a different form of white matter hyperintensities (WMH)
Time frame: at the time of specific imaging (between Day 1 to Day 60)
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
14 secondary outcomes
Frequency of different WMH subtypes in different types of small cerebral vessel disease
Time frame: at the time of specific imaging (between Day 1 to Day 60)
Frequency of large tract involvement
Time frame: at the time of specific imaging (between Day 1 to Day 60)
Global cognitive function
Time frame: at inclusion
Language
Time frame: at inclusion
Spatial exploration
Time frame: at inclusion
Spatial memory
Time frame: at inclusion
Visual memory
Time frame: at inclusion
Episodic verbal memory
Time frame: at inclusion
Working memory
Time frame: at inclusion
Executive function
Time frame: at inclusion
Attentional Performances status
Time frame: at inclusion
Depression and Anxiety status
Time frame: at inclusion
Apathy status
Time frame: at inclusion
Pulse wave Velocity count
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Resche-Rigon, Pr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Arm in people with Cerebral Small Vessel Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Jouvent, Pr (0149956529, eric.jouvent@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a different form of white matter hyperintensities (WMH) (time frame: at the time of specific imaging (between Day 1 to Day 60)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.