NCT06961864

Brief Summary

The goal of this study is to learn more about the brain pathways and activity involved in creating Visual Snow Syndrome (VSS). The main questions it aims to answer are:

  • Does VSS arise from spontaneous activity in brain pathways?
  • Where in the brain does the activity contributing to VSS arise?
  • How does brain activity contribute to VSS? Participants will:
  • Undergo assessments and questionnaires to understand visual and mental symptoms, cognitive, and sensory function.
  • Make visual judgements based on images presented to them both inside and outside a magnetic resonance imaging (MRI) machine.
  • Undergo scanning of their brain while inside of an MRI machine.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
48mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2025Mar 2030

Study Start

First participant enrolled

April 11, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

April 29, 2025

Last Update Submit

January 12, 2026

Conditions

Keywords

Visual Snow SyndromeVisual SnowMigraineFloatersPalinopsiaPhotophobiaNyctalopiaEntoptic phenomenaVisual trailingAdaptationMagnetic resonance spectroscopyMRSMagnetic resonance imagingMRIUniversity of MinnesotaAfterimagesPoor night visionLight sensitivityPersistent positive visual phenomenaStatic

Outcome Measures

Primary Outcomes (3)

  • Psychophysical Adaptation Task Performance

    Visual tasks will consist of perceptual judgments following adaptation (e.g., subject will report when internal or external / simulated visual snow appears the same on the left or right side of the screen). Measures will be compared for visual target stimuli in different task conditions and experiments, with the goal of understanding the neural basis of visual snow.

    1.5-2 hours per session, with experiments divided across multiple (e.g., 3) sessions

  • Functional Magnetic Resonance Imaging (fMRI) Measures

    7 tesla fMRI data will be acquired during visual paradigms designed to measure neural responses with and without adaptation. FMRI data will be processed and analyzed to quantify the effect of adaptation across different regions in visual cortex.

    1-2 hours per session, with experiments split across multiple (e.g., 3) sessions

  • Magnetic Resonance Spectroscopy (MRS)

    7 telsa MRS data will be acquired to quantify the concentration of different brain chemicals in brain areas including visual cortex.

    1-2 hours

Secondary Outcomes (1)

  • Clinical Symptom Scores

    1-2 hours

Study Arms (2)

People with Visual Snow Syndrome

ACTIVE COMPARATOR
Behavioral: Visual AdaptationBehavioral: Assessments and QuestionnairesDevice: Functional Magnetic Resonance Imaging (fMRI)Device: Magnetic Resonance Imaging (MRS)

Non-snow Controls

PLACEBO COMPARATOR
Behavioral: Visual AdaptationBehavioral: Assessments and QuestionnairesDevice: Functional Magnetic Resonance Imaging (fMRI)Device: Magnetic Resonance Imaging (MRS)

Interventions

Presentation of visual stimuli to quantify the appearance of visual snow or its effects in the visual system of the brain.

Non-snow ControlsPeople with Visual Snow Syndrome

Administration of clinical assessments and questionnaires to gather information about visual and mental symptoms, cognitive, and sensory function.

Non-snow ControlsPeople with Visual Snow Syndrome

7 tesla fMRI data will be acquired during visual paradigms designed to measure neural responses with and without adaptation.

Non-snow ControlsPeople with Visual Snow Syndrome

7 tesla MRS data will be acquired to quantify the concentrations of different brain chemicals in brain regions including visual cortex.

Non-snow ControlsPeople with Visual Snow Syndrome

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 60 years old
  • Normal (20/25 or better in each eye) or corrected-to-normal vision (MR-compatible glasses will be provided as needed)
  • Ability to comply with study instructions
  • Individuals who have a current diagnosis of VSS from a neuro-ophthalmologist or meet diagnostic criteria of VSS (experience of dynamic dots across the visual field persisting longer than 3 months and at least 2 of the following additional visual symptoms: palinopsia, entoptic phenomena, trails behind moving objects, photophobia, or nyctalopia)
  • Individuals living in Minnesota within 2 hours of the study site
  • Between the ages of 18 and 60 years old
  • Normal (20/25 or better in each eye) or corrected-to-normal vision (MR-compatible glasses will be provided as needed)
  • Ability to comply with study instructions
  • Individuals living in Minnesota within 2 hours of the study site

You may not qualify if:

  • Not being fluent in English or another language for which interpretation/translation services are available
  • A diagnosed or self-reported intellectual disability
  • Current substance dependence (besides nicotine), or drug dependence with tolerance or withdrawal within past 12 months
  • Hallucinogenic substance use within the past 12 months or hallucinogenic substance use within 12 months prior to onset of VSS symptoms
  • Severe central nervous system disease
  • Head injury with skull fracture or loss of consciousness for more than thirty minutes
  • Presence of a physical problem that would render study measures difficult or impossible to administer or interpret (e.g., visual field loss)
  • Age less than 18 years or greater than 60 years
  • Metal in the body that cannot be approved by the CMRR safety committee
  • Pregnancy
  • Conditions that affect neuro-hemodynamic coupling
  • Claustrophobia
  • Inability to lie still for at least an hour
  • Weight in excess of 440 lbs
  • Any vision anomaly aside from VS or refractive error (e.g., strabismus/ crossed eyes, lazy eyes, color blindness)
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (3)

  • Montoya SA, Mulder CB, Allison KD, Lee MS, Engel SA, Schallmo MP. What does visual snow look like? Quantification by matching a simulation. J Vis. 2024 Jun 3;24(6):3. doi: 10.1167/jov.24.6.3.

    PMID: 38837169BACKGROUND
  • Montoya SA, Hillstrom AJ, Allison KD, Mulder CB, Moser HR, Lee MS, Schallmo MP, Engel SA. Visual Snow Is Susceptible to the Motion Aftereffect. Invest Ophthalmol Vis Sci. 2025 Oct 1;66(13):23. doi: 10.1167/iovs.66.13.23.

    PMID: 41085357BACKGROUND
  • Montoya SA, Mulder CB, Lee MS, Schallmo MP, Engel SA. Adapting to Visual Noise Alleviates Visual Snow. Invest Ophthalmol Vis Sci. 2023 Dec 1;64(15):23. doi: 10.1167/iovs.64.15.23.

    PMID: 38117246BACKGROUND

Related Links

MeSH Terms

Conditions

visual snow syndromeMigraine Disordersvitreous floaterspalinopsiaPhotophobiaNight BlindnessVitamin A Deficiency

Interventions

Surveys and QuestionnairesMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Michael-Paul Schallmo, Ph.D.

    University of Minnesota, Department of Psychiatry and Behavioral Sciences

    PRINCIPAL INVESTIGATOR
  • Stephen A Engel, Ph.D.

    University of Minnesota, Department of Psychology

    STUDY CHAIR
  • Michael S Lee, M.D.

    University of Minnesota, Department of Ophthalmology and Visual Neurosciences

    STUDY CHAIR
  • Abby Metzler, M.D.

    University of Minnesota, Department of Neurology

    STUDY CHAIR
  • Malgorzata Marjanska, Ph.D.

    University of Minnesota, Department of Radiology

    STUDY CHAIR
  • Carrie E Robertson, M.D.

    Mayo Clinic, Rochester, Department of Neurology

    STUDY CHAIR

Central Study Contacts

Michael-Paul Schallmo, Ph.D.

CONTACT

Hannah Moser, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 8, 2025

Study Start

April 11, 2025

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified data will be shared to a public repository at the end of the study. Data that will be shared include the study protocol, informed consent form, analytic code, behavioral data, and brain imaging data. OpenNuero.org will be used for data and Github.com will be used to share code.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data will be shared within 12 months of the completion of our study or publication of a relevant manuscript, whichever comes first.
Access Criteria
Everyone will be able to access the data shared to the repositories.

Locations