Visual Snow SyndromeNEVICOGNCT05229731
Description of the Neurovisual and Radiological Specificities of Patients With Visual Snow Syndrome
An observational study of Visual Snow Syndrome, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
NEVICOG is a single-center study evaluating neurovisual and radiological specificities in patients with visual snow syndrome (VSS) compared to a control population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Snow Syndrome
- What is being tested?
- Neurovisual evaluation and Cerebral MRI
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2022to 13 Apr 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
- Adult, Older adult
Study population: Patients diagnosed with of visual snow syndrome according to international criteria compared to control patients without any visual snow syndrome
Who may be able to join
- Case group:
- Patient aged up to 55
- Diagnosis of visual snow syndrome according to the international criteria
- Visual snow symptoms still present
- Express consent to participate in the study
- Control group:
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- Person aged up to 60
- Matched to an SNV patient on age (+/- 5 years) and sex
- Express consent to participate in the study
Who cannot join
- Case group:
- Patient with an absolute or relative contraindication to MRI (claustrophobia, incompatible implantable device, etc.)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Non-French speaking patient
- Added psychiatric or neurodegenerative pathology unrelated to visual snow likely to induce neurocognitive and neurovisual disorders in the short or long term
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- Ophthalmologic comorbidity that may interfere with the interpretation of examinations
- Control group:
- Patient with an absolute or relative contraindication to MRI (claustrophobia, incompatible implantable device, etc.)
- Person benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Non-French speaking person
- Psychiatric or neurodegenerative pathology likely to induce neurocognitive and neurovisual disorders in the short or long term
- Ophthalmologic comorbidity that may interfere with the interpretation of examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of the Neurovisual and Radiological Specificities of Patients With Visual Snow
NEVICOG is a single-center study evaluating neurovisual and radiological specificities in patients with visual snow syndrome (VSS) compared to a control population.
Read the detailed description
Visual snow syndrome (SNV) is characterized by a continuous grainy or pixelated visual sensation additional to the perceived image. Patients often report a feeling similar to seeing noise from cathode-ray televisions.
The prevalence is not well known but about 2% of the population could be reached. Although benign and stable, this pathology is often troublesome in everyday life.
Its precise etiology remains unknown to this day. Ophthalmologic explorations do not reveal any significant abnormalities. Neurologically, "standard" examinations appear normal. Only the examinations carried out in the context of research have been able to highlight anomalies such as an imbalance between visual cortical inhibition and excitation as well as a high spontaneous neural triggering and hypermetabolism of the associative visual cortex (functional MRI, PET- MRI). In addition, the Visual Evoked Potentials show a lack of habituation, testifying to cortical hyperexcitability.
To our knowledge, no specific neurovisual study focusing on the functions involved in the processing of visual information has been carried out to date. We propose the realization of a complete evaluation made up of existing tasks as well as the adaptation of some of them specific to SNV.
The posterior abnormalities currently highlighted by imaging have been carried out in examinations not available on a daily basis. A non-invasive brain MRI study will be carried out in our patients using more recent techniques (MRI with arterial spin labelling or ASL for Arterial Spin Labelling, and diffusion tensor imaging or DTI for Diffusion Tensor Imaging) in order to search for possible posterior lesions and clinical radiological correlations.
Thus, this study aims to carry out a more in-depth neurovisual exploration of this syndrome, in order to allow a better understanding of this frequent and disabling disorder on a daily basis.
- Conditions
- Visual Snow Syndrome
- Being tested
- Neurovisual evaluation, Cerebral MRI
- Keywords
- Visual Snow Syndrome
- Medical subject headings
- visual snow syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurovisual evaluationProcedure or surgery
Standardized tests and scales classically used during a neurovisual evaluation,
Cerebral MRIProcedure or surgery
Sequences realized :
- 3D T1 TFE i1.0
- 3D FLAIR i1.0
- 2D T2 0.3 coro, centré sur les orbites
- 3D T2 i0.6
- SWIp 0.6
- 3D PD T2 NO, centré sur les orbites
- 3D ASL
- DTI 64dir
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patients with visual snow syndrome according to international criteria Receives: Procedure: Neurovisual evaluation; Procedure: Cerebral MRI | |
| Control group | Patients without visual snow syndrome according to international criteria Receives: Procedure: Neurovisual evaluation; Procedure: Cerebral MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of the neurovisual assessment
Rey-Osterrieth test will be used to assess the neurovisual ability. Patients have to reproduce a figure composed of 18 elements. A score between 0 and 2 is given to each of these elements according to their accuracy. The score varies from 0 to 36 and assesses the patient's visuo-constructive ability (36 corresponds to the best visuo-constructive ability).
Measured: 1 day (Inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start13 Apr 2022 (estimated)
- Primary completion13 Apr 2022 (estimated)
- Study completion13 Apr 2022 (estimated)
Why it stopped: The investigators no longer want to do the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Snow SyndromeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Nina Di Donato, Principal investigator, Hôpital Fondation A. de RothschildRomain Deschamps, MD, Study director, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229731
- Sponsor's protocol ID
- NDO_2021_17
- Acronym
- NEVICOG
- Status last verified
- Apr 2022
- First submitted
- 10 Sep 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Neurovisual and Radiological Specificities of Patients With Visual Snow
- ClinicalTrials.gov ID
- NCT05229731
- Acronym / sponsor ID
- NEVICOG / NDO_2021_17
- Conditions
- Visual Snow Syndrome
- Keywords
- Visual Snow Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The investigators no longer want to do the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 13 Apr 2022 (estimated)
- Primary completion
- 13 Apr 2022 (estimated)
- Study completion
- 13 Apr 2022 (estimated)
- First posted
- 8 Feb 2022 (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.
NEVICOG is a single-center study evaluating neurovisual and radiological specificities in patients with visual snow syndrome (VSS) compared to a control population.
Detailed description
Visual snow syndrome (SNV) is characterized by a continuous grainy or pixelated visual sensation additional to the perceived image. Patients often report a feeling similar to seeing noise from cathode-ray televisions.
The prevalence is not well known but about 2% of the population could be reached. Although benign and stable, this pathology is often troublesome in everyday life.
Its precise etiology remains unknown to this day. Ophthalmologic explorations do not reveal any significant abnormalities. Neurologically, "standard" examinations appear normal. Only the examinations carried out in the context of research have been able to highlight anomalies such as an imbalance between visual cortical inhibition and excitation as well as a high spontaneous neural triggering and hypermetabolism of the associative visual cortex (functional MRI, PET- MRI). In addition, the Visual Evoked Potentials show a lack of habituation, testifying to cortical hyperexcitability.
To our knowledge, no specific neurovisual study focusing on the functions involved in the processing of visual information has been carried out to date. We propose the realization of a complete evaluation made up of existing tasks as well as the adaptation of some of them specific to SNV.
The posterior abnormalities currently highlighted by imaging have been carried out in examinations not available on a daily basis. A non-invasive brain MRI study will be carried out in our patients using more recent techniques (MRI with arterial spin labelling or ASL for Arterial Spin Labelling, and diffusion tensor imaging or DTI for Diffusion Tensor Imaging) in order to search for possible posterior lesions and clinical radiological correlations.
Thus, this study aims to carry out a more in-depth neurovisual exploration of this syndrome, in order to allow a better understanding of this frequent and disabling disorder on a daily basis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Procedure: Neurovisual evaluation, Procedure: Cerebral MRIPatients with visual snow syndrome according to international criteria |
| Control group | – | Procedure: Neurovisual evaluation, Procedure: Cerebral MRIPatients without visual snow syndrome according to international criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with of visual snow syndrome according to international criteria compared to control patients without any visual snow syndrome
Key inclusion criteria (9 listed)
- Patient aged up to 55
- Diagnosis of visual snow syndrome according to the international criteria
- Visual snow symptoms still present
- Express consent to participate in the study
- Person aged up to 60
Key exclusion criteria (14 listed)
- Patient with an absolute or relative contraindication to MRI (claustrophobia, incompatible implantable device, etc.)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Non-French speaking patient
- Added psychiatric or neurodegenerative pathology unrelated to visual snow likely to induce neurocognitive and neurovisual disorders in the short or long term
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 |
|---|---|---|
| Neurovisual evaluationStandardized tests and scales classically used during a neurovisual evaluation, | Procedure or surgery | Case group, Control group |
| Cerebral MRISequences realized : * 3D T1 TFE i1.0 * 3D FLAIR i1.0 * 2D T2 0.3 coro, centré sur les orbites * 3D T2 i0.6 * SWIp 0.6 * 3D PD T2 NO, centré sur les orbites * 3D ASL * DTI 64dir | Procedure or surgery | Case group, Control group |
Primary outcome
Results of the neurovisual assessment
Time frame: 1 day (Inclusion)
Rey-Osterrieth test will be used to assess the neurovisual ability. Patients have to reproduce a figure composed of 18 elements. A score between 0 and 2 is given to each of these elements according to their accuracy. The score varies from 0 to 36 and assesses the patient's visuo-constructive ability (36 corresponds to the best visuo-constructive ability).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
Related trials for Visual Snow Syndrome
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Not yet recruiting
MBCT-vision VSS RCT
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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.
Nina Di Donato principal investigator
Hôpital Fondation A. de Rothschild
Romain Deschamps, MD study director
Hôpital Fondation A. de Rothschild
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 Visual Snow Syndrome, run by Fondation Ophtalmologique Adolphe de Rothschild 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 9 inclusion and 14 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: withdrawn, as of the sponsor's last update on 20 Apr 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of the neurovisual assessment (time frame: 1 day (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 20 Apr 2022.