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Neurofeedback in Visual Snow

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Active, not recruiting

Conditions

Visual Snow Syndrome
Neuro-Ophthalmology

Treatments

Other: neurofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT04902365
NeurofeebackSnow

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

Patients group 1
Active Comparator group
Description:
This group will regulate a brain region by real-time functional magnetic resonance imaging that is centrally involved in the visual snow syndrome
Treatment:
Other: neurofeedback
Patients group 2
Placebo Comparator group
Description:
This group will regulate a brain region by real-time functional magnetic resonance imaging that is not centrally involved in the visual snow syndrome
Treatment:
Other: neurofeedback

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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