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Active, not recruitingNCT04902365Updated Jun 15, 2023

Neurofeedback in Visual Snow

An interventional study of neurofeedback in Visual Snow Syndrome and Neuro-Ophthalmology, sponsored by University of Zurich. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by University of Zurich · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 1 month ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Visual snow (VS) is a distressing, life-impacting condition with unrelenting and persistent disturbing visual phenomena. Disease onset is usually around age 20 and is characterized by continuous perception of innumerable flickering dots (like a 'broken television'). The disease is often accompanied by comorbidities such as migraine, tinnitus, depression and anxiety.

Neuronally, VS patients show cerebral hypermetabolism, resulting in altered neuronal excitability, as well as increased grey matter volume in parts of the visual cortex.

For this pilot study, the investigators aim to recruit VS patients. In a double-blind, randomized and placebo-controlled longitudinal experiment, the investigators will use real-time functional magnetic resonance imaging (rtfMRI) neurofeedback to teach patients to downregulate activity in different regions of the visual cortex.

The investigators hypothesize that neurofeedback will allow patients to learn to downregulate their abnormal visual cortex activity. Moreover, the investigators predict that a stronger downregulation of activity from the lingual gyrus will correlate with a more pronounced decrease in VS symptoms.

Read the detailed description

Currently, there is no pharmacological or non-pharmacological treatment available that significantly reduces the high disease burden produced by VS. Thus, there is an unmet need for an appropriate intervention to treat patients with VS. In this study, the investigators will:

  1. Test if rtfMRI-based neurofeedback could serve as therapeutic option for patients with VS.

    Here, the investigators will examine correlations of neurofeedback regulation success with clinical scores 3 after neurofeedback

  2. Examine brain function and structure in patients with VS

Primary and secondary endpoint/outcome(s)

  • Primary outcome variable: VS symptom severity before and after rtfMRI, using standardized clinical assessment.
  • Secondary outcome variables: fMRI and structural MRI, clinical questionnaires (visual function, anxiety, depression, tinnitus, and migraine), parameters from psychophysical data (assessed before and after neurofeedback).
  • Linear Mixed model analysis will be performed (using clinical and imaging data) to estimate the impact of rtfMRI on clinical progression and brain function/structure.
02

Conditions studied

  • Visual Snow Syndrome
  • Neuro-Ophthalmology

Keywords

  • neurofeedback
  • real-time functional magnetic resonance imaging
03

In context

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with VS (≥ 18 to ≤ 60 years), which can read and sign the informed consent form.
  • Male and female
  • Healthy controls (≥ 18 to ≤ 60 years), which can read and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • MR exclusion criteria (patients only): metallic items in the body (i.e. eye splinter, MR incompatible implants), pacemaker, claustrophobia).
  • pregnant participants
  • participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease and with major psychiatric disorders such as schizophrenia, depression, or anxiety disorder requiring pharmacological treatment (psycho-pharmaca).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Patients group 1

    This group will regulate a brain region by real-time functional magnetic resonance imaging that is centrally involved in the visual snow syndrome

    Other: neurofeedback

  • Placebo comparator
    Patients group 2

    This group will regulate a brain region by real-time functional magnetic resonance imaging that is not centrally involved in the visual snow syndrome

    Other: neurofeedback

Interventions

  • Otherneurofeedback

    (based on real-time functional magnetic resonance signals)

06

What researchers measure

Primary outcomes

  1. symptom severity

    Changes in symptom severity before and after real-time fMRI neurofeedback

    Time frame: Acute after neurofeedback and 3 months after neurofeedback

Secondary outcomes

  1. Magnetic resonance imaging

    Assessment of Magnetic resonance imaging parameters related to brain function and structure

    Time frame: before and immediately after the neurofeedback sessions

07

Study locations

1 site
  • University Hospital Zurich
    Zurich, 8091, Switzerland
08

References and documents

Individual participant data

Plan to share: Undecided — The datasets presented in this study are not readily available because due to Swiss law, the researchers must assess whether the use of the data and coded datasets are within the primary scope of the informed consent. Subject level data is only available upon request and after the researchers have reviewed the purpose of the inquiry. Requests to access the datasets should be directed to Dr. Lars Michels, lars.michels@usz.ch.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04902365
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
May 26, 2021
Start date
Jan 14, 2022
Primary completion
Aug 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Jun 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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