Small Vessel Cerebrovascular DiseaseSMACSNCT04170673
Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases
An observational study of Small Vessel Cerebrovascular Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In daily practice, several scales are used to evaluate patients with small vessel diseases of the brain (SVD). However, these scales exclude key symptoms such as apathy and mood disorders observed in SVD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Vessel Cerebrovascular Disease
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2019to 15 Dec 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with small vessel disease will be recruited from the Department of Neurology at Lariboisière Hospital. The study will be proposed to patients when they come to Lariboisière Hospital for hospitalization (full hospitalization or day hospitalization) or consultation.
Who may be able to join
- Age ≥ 18 years
- French mother language
- French reading and writing
- The patient can fulfil the questionnaire on his own, without any help.
- Brain imaging suggestive of SVD: confluent white matter hypersignals with symmetric distribution, small deep infarction, cerebral haemorrhage, microbleeds
- Optional:
- Presence of informative companion in contact with the patient at least once every 15 days
Who cannot join
- Presence of unacquired cognitive impairment (mental retardation, developmental disorders)
- Presence of non-vascular leukoencephalopathy
- Clinical picture and evolution suggesting a degenerative disease
- Serious or unstable psychiatric problems (psychoses, severe depression)
- Unstable clinical status
Trial locations and contacts
1 site in 1 country.
Matthieu Resche-Rigon contact
France1 site, 1 recruiting
- Recruiting
Lariboisiere hospital
Paris, 75010
Nathalie GASTELLIER, PhD, 149956872 ext. +33, nathalie.gastellier@aphp.fr
matthieu RESCHE-RIGON, MD-PhD, 142499742 ext. +33, matthieu.resche-rigon@univ-paris-diderot.fr
About this study
In daily practice, several scales are used to evaluate patients with small vessel diseases of the brain (SVD). However, these scales exclude key symptoms such as apathy and mood disorders observed in SVD. Furthermore, the use of a combination of scales does not allow neither a very sensitive assessment of clinical changes, neither an overall assessment of a patient's outcome.
Moreover, there is no scale dedicated to cognitive, emotional and behavioural complaints in patients with SVD. These patients are evaluated with scales used in neurodegenerative diseases such as Alzheimer's disease and frontotemporal dementia. These are scales that have been developed in the elderly and they are not sensitive to minor complaints. It is needful to develop scales adapted to patients with SVD in order to understand the consequences of the disease symptoms on their daily life at inclusion and during follow-up.
- Conditions
- Small Vessel Cerebrovascular Disease
- Medical subject headings
- Cerebral Small Vessel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a Global Clinical Severity Scale in Patients with cerebral SVD
The primary outcome is to develop this scale, thus precise definition of the scale is not available
Measured: 3 years post-inclusion
Secondary outcomes (5)
Internal validity of each scale
To analyze correlations between items, scale structure, o floor and ceiling effects and profiles of missing data
Measured: 3 years post-inclusion
Intra evaluator reliability
Measured: 3 years post-inclusion
Inter-evaluator reliability
Measured: 3 years post-inclusion
Scale validity
Measured: 3 years post-inclusion
Scale sensitivity to change
To determine clinically important minimal difference.
Measured: 3 years post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start15 Dec 2019
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Vessel Cerebrovascular DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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
- NCT04170673
- Sponsor's protocol ID
- APHP190597
- Acronym
- SMACS
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 7 Jul 2020
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases
- ClinicalTrials.gov ID
- NCT04170673
- Acronym / sponsor ID
- SMACS / APHP190597
- Conditions
- Small Vessel Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 20 Nov 2019 (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.
In daily practice, several scales are used to evaluate patients with small vessel diseases of the brain (SVD). However, these scales exclude key symptoms such as apathy and mood disorders observed in SVD. Furthermore, the use of a combination of scales does not allow neither a very sensitive assessment of clinical changes, neither an overall assessment of a patient's outcome.
Moreover, there is no scale dedicated to cognitive, emotional and behavioural complaints in patients with SVD. These patients are evaluated with scales used in neurodegenerative diseases such as Alzheimer's disease and frontotemporal dementia. These are scales that have been developed in the elderly and they are not sensitive to minor complaints. It is needful to develop scales adapted to patients with SVD in order to understand the consequences of the disease symptoms on their daily life at inclusion and during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with small vessel disease will be recruited from the Department of Neurology at Lariboisière Hospital. The study will be proposed to patients when they come to Lariboisière Hospital for hospitalization (full hospitalization or day hospitalization) or consultation.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- French mother language
- French reading and writing
- The patient can fulfil the questionnaire on his own, without any help.
- Brain imaging suggestive of SVD: confluent white matter hypersignals with symmetric distribution, small deep infarction, cerebral haemorrhage, microbleeds
Key exclusion criteria (5 listed)
- Presence of unacquired cognitive impairment (mental retardation, developmental disorders)
- Presence of non-vascular leukoencephalopathy
- Clinical picture and evolution suggesting a degenerative disease
- Serious or unstable psychiatric problems (psychoses, severe depression)
- Unstable clinical status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a Global Clinical Severity Scale in Patients with cerebral SVD
Time frame: 3 years post-inclusion
The primary outcome is to develop this scale, thus precise definition of the scale is not available
5 secondary outcomes
Internal validity of each scale
Time frame: 3 years post-inclusion
Intra evaluator reliability
Time frame: 3 years post-inclusion
Inter-evaluator reliability
Time frame: 3 years post-inclusion
Scale validity
Time frame: 3 years post-inclusion
Scale sensitivity to change
Time frame: 3 years post-inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- 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 contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Vessel Cerebrovascular Disease, 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 5 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 7 Jul 2020. 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 Sophie TEZENAS DU MONTCEL (+33142160582, sophie.tezenas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a Global Clinical Severity Scale in Patients with cerebral SVD (time frame: 3 years post-inclusion). 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 7 Jul 2020.