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Neurofeedback in Visual Snow

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ClinicalTrials.gov Identifier: NCT04902365
Recruitment Status : Not yet recruiting
First Posted : May 26, 2021
Last Update Posted : August 3, 2021
Sponsor:
Collaborator:
USZ Foundation
Information provided by (Responsible Party):
University of Zurich

Brief 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.


Condition or disease Intervention/treatment Phase
Visual Snow Syndrome Neuro-Ophthalmology Other: neurofeedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

50 patients (25 in each arm)

Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Neurofeedback for Patients With Visual Snow
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

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)




Primary Outcome Measures :
  1. symptom severity [ Time Frame: Acute after neurofeedback and 3 months after neurofeedback ]
    Changes in symptom severity before and after real-time fMRI neurofeedback


Secondary Outcome Measures :
  1. Magnetic resonance imaging [ Time Frame: before and immediately after the neurofeedback sessions ]
    Assessment of Magnetic resonance imaging parameters related to brain function and structure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04902365


Locations
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Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Contact: Lars Michels, Dr.    +41442554965    lars.michels@usz.ch   
Contact: Jeanette Popovova, Msc.       Jeanette.popovova@usz.ch   
Sponsors and Collaborators
University of Zurich
USZ Foundation
Additional Information:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04902365    
Other Study ID Numbers: NeurofeebackSnow
First Posted: May 26, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
neurofeedback
real-time functional magnetic resonance imaging