Stroke, IschemicVISUO-CEREBRONCT04920461
Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes
A study testing Additional MRI sequences and Neuropsychological assessment in people with Stroke, Ischemic and Cerebellar Lesions, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Cerebellar Lesions
- What is being tested?
- Additional MRI sequences and Neuropsychological assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2020to Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Being able to pass initial neuropsychological tests within 10 days after stroke
Who cannot join
- Previous central neural system/psychiatric/eye disease (including severe cranial trauma)
- Chronic alcoholism
- MRI contraindication.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
VOILLY Alice, MD, avoilly@chu-besancon.fr
Eloi MAGNIN, MD, PhD
About this study
This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.
- Conditions
- Stroke, Ischemic, Cerebellar Lesions
- Being tested
- Additional MRI sequences, Neuropsychological assessment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional MRI sequencesDevice
Additional MRI sequences (3D T2 SPACE sequence, 4/5 minutes approximatively)
Neuropsychological assessmentOther
Neurovisual function assessed with neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| Additional MRI sequences | Experimental | Not described Receives: Device: Additional MRI sequences; Other: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Neuro-Visual Disorder
Presence of neuro-visual disorder will be confirmed by obtaining at least 2 pathological scores at following neuropsychological tests:
- Rey \& Taylor figures (score from 0 to 36, maximum)
- Judgment of Line Orientation (score from 0 to 36, maximum)
- Weschler Adult Intelligence Scale (final score is intelligence quotient, with an average score is fixed at 100)
- Test of Attentional Performance
- Visual Object and Space Perception Battery (eight tests each designed to assess a particular aspect of object or space perception, while minimising the involvement of other cognitive skills)
- Visual agnosia assesment protocole (noted on 10 points)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start16 Apr 2020
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eloi MAGNIN, MD, PhD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920461
- Sponsor's protocol ID
- P/2019/423
- Acronym
- VISUO-CEREBRO
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes
- ClinicalTrials.gov ID
- NCT04920461
- Acronym / sponsor ID
- VISUO-CEREBRO / P/2019/423
- Conditions
- Stroke, Ischemic, Cerebellar Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 9 Jun 2021 (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.
This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional MRI sequences | Experimental | Device: Additional MRI sequences, Other: Neuropsychological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent form
- Being able to pass initial neuropsychological tests within 10 days after stroke
Key exclusion criteria (3 listed)
- Previous central neural system/psychiatric/eye disease (including severe cranial trauma)
- Chronic alcoholism
- MRI contraindication.
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 |
|---|---|---|
| Additional MRI sequencesAdditional MRI sequences (3D T2 SPACE sequence, 4/5 minutes approximatively) | Device | Additional MRI sequences |
| Neuropsychological assessmentNeurovisual function assessed with neuropsychological tests | Other | Additional MRI sequences |
Primary outcome
Presence of Neuro-Visual Disorder
Time frame: Month 3
Presence of neuro-visual disorder will be confirmed by obtaining at least 2 pathological scores at following neuropsychological tests: * Rey \& Taylor figures (score from 0 to 36, maximum) * Judgment of Line Orientation (score from 0 to 36, maximum) * Weschler Adult Intelligence Scale (final score is intelligence quotient, with an average score is fixed at 100) * Test of Attentional Performance * Visual Object and Space Perception Battery (eight tests each designed to assess a particular aspect of object or space perception, while minimising the involvement of other cognitive skills) * Visual agnosia assesment protocole (noted on 10 points)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Eloi MAGNIN, MD, PhD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional MRI sequences and Neuropsychological assessment in people with Stroke, Ischemic and Cerebellar Lesions, run by Centre Hospitalier Universitaire de Besancon 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 2 inclusion and 3 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 9 Jun 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 Alice VOILLY, MD (0033381668236, avoilly@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Neuro-Visual Disorder (time frame: Month 3). 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 9 Jun 2021.