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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05229731
Other study ID # NDO_2021_17
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date April 13, 2022
Est. completion date April 13, 2022

Study information

Verified date April 2022
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 13, 2022
Est. primary completion date April 13, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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 Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Neurovisual evaluation
Standardized tests and scales classically used during a neurovisual evaluation,
Cerebral MRI
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

Locations

Country Name City State
France Hôpital Fondation A. de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
See also
  Status Clinical Trial Phase
Completed NCT04184726 - Mindfulness Based Cognitive Therapy Modified for Visual Symptoms (MBCT-vision) N/A
Not yet recruiting NCT06018103 - MBCT-vision VSS RCT N/A
Completed NCT05569733 - Simultaneous Fluorodeoxyglucose Positron Emission Tomography (PET) and Magnetic Resonance (MR) in Visual Snow Syndrome
Active, not recruiting NCT04902365 - Neurofeedback in Visual Snow N/A
Completed NCT04925232 - Transcranial Magnetic Stimulation For Visual Snow Syndrome N/A