NCT05229731

Brief Summary

NEVICOG is a single-center study evaluating neurovisual and radiological specificities in patients with visual snow syndrome (VSS) compared to a control population.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

Same day

First QC Date

September 10, 2021

Last Update Submit

April 13, 2022

Conditions

Visual Snow Syndrome

Keywords

Visual Snow Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 day (Inclusion)

Study Arms (2)

Case group

Patients with visual snow syndrome according to international criteria

Procedure: Neurovisual evaluationProcedure: Cerebral MRI

Control group

Patients without visual snow syndrome according to international criteria

Procedure: Neurovisual evaluationProcedure: Cerebral MRI

Interventions

Neurovisual evaluationPROCEDURE

Standardized tests and scales classically used during a neurovisual evaluation,

Case groupControl group
Cerebral MRIPROCEDURE

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

Case groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with of visual snow syndrome according to international criteria compared to control patients without any visual snow syndrome

You may qualify if:

  • 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:
  • Person aged up to 60
  • Matched to an SNV patient on age (+/- 5 years) and sex
  • Express consent to participate in the study

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

visual snow syndrome

Study Officials

  • Nina Di Donato

    Hôpital Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

  • Romain Deschamps, MD

    Hôpital Fondation A. de Rothschild

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2021

First Posted

February 8, 2022

Study Start

April 13, 2022

Primary Completion

April 13, 2022

Study Completion

April 13, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

FR(1)