Neurofeedback in Visual Snow

Visual Snow Syndrome Clinical Trial

Official title:

Neurofeedback for Patients With Visual Snow

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04902365
• Other study ID #: NeurofeebackSnow
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Neuro-Ophthalmology
• Visual Snow Syndrome

Intervention

Other:
• neurofeedback
(based on real-time functional magnetic resonance signals)

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom severity	Changes in symptom severity before and after real-time fMRI neurofeedback	Acute after neurofeedback and 3 months after neurofeedback
Secondary	Magnetic resonance imaging	Assessment of Magnetic resonance imaging parameters related to brain function and structure	before and immediately after the neurofeedback sessions

External Links

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