Neurofeedback in Visual Snow

NCT04902365 | Unknown

• 1 other identifier: NeurofeebackSnow
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Snow Syndrome; Neuro-Ophthalmology

Keywords

neurofeedback; real-time functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• symptom severity

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

  Acute after neurofeedback and 3 months after neurofeedback

Secondary Outcomes (1)

• Magnetic resonance imaging

  before and immediately after the neurofeedback sessions

Study Arms (2)

Patients group 1

ACTIVE COMPARATOR

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

Patients group 2

PLACEBO COMPARATOR

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

neurofeedback OTHER

(based on real-time functional magnetic resonance signals)

Patients group 1; Patients group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

visual snow syndrome

Interventions

Neurofeedback

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 26, 2021
• Study Start: January 14, 2022
• Primary Completion: August 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CH (1)