Neurofeedback in Visual Snow

Neurofeedback for Patients With Visual Snow

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Visual Snow Syndrome; Neuro-Ophthalmology
• Intervention / Treatment: Other: neurofeedback

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; (based on real-time functional magnetic resonance signals)
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; (based on real-time functional magnetic resonance signals)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptom severity	Changes in symptom severity before and after real-time fMRI neurofeedback	Acute after neurofeedback and 3 months after neurofeedback

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic resonance imaging	Assessment of Magnetic resonance imaging parameters related to brain function and structure	before and immediately after the neurofeedback sessions

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: USZ Foundation

Publications and helpful links

Helpful Links

• Lists projects of the Iten-Kohaut foundation (our project is funded by this foundation)

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Estimated): August 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: neurofeedback; real-time functional magnetic resonance imaging
• Other Study ID Numbers: NeurofeebackSnow

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No