Visual Snow SyndromeNCT04902365
Neurofeedback in Visual Snow
A study testing neurofeedback in people with Visual Snow Syndrome and Neuro-Ophthalmology, run by University of Zurich at 1 site in Switzerland.
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'). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Snow Syndrome, Neuro-Ophthalmology
- What is being tested?
- neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Jan 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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:
- 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
- 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.
- Conditions
- Visual Snow Syndrome, Neuro-Ophthalmology
- Being tested
- neurofeedback
- Keywords
- neurofeedback, real-time functional magnetic resonance imaging
- Medical subject headings
- visual snow syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurofeedbackOther
(based on real-time functional magnetic resonance signals)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom severity
Changes in symptom severity before and after real-time fMRI neurofeedback
Measured: Acute after neurofeedback and 3 months after neurofeedback
Secondary outcomes (1)
Magnetic resonance imaging
Assessment of Magnetic resonance imaging parameters related to brain function and structure
Measured: before and immediately after the neurofeedback sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start14 Jan 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Snow SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902365
- Sponsor's protocol ID
- NeurofeebackSnow
- Status last verified
- Jun 2023
- First submitted
- 20 May 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback for Patients With Visual Snow
- ClinicalTrials.gov ID
- NCT04902365
- Acronym / sponsor ID
- NeurofeebackSnow
- Conditions
- Visual Snow Syndrome, Neuro-Ophthalmology
- Keywords
- neurofeedback, real-time functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Patients group 1 | Active comparator | Other: neurofeedbackThis group will regulate a brain region by real-time functional magnetic resonance imaging that is centrally involved in the visual snow syndrome |
| Patients group 2 | Placebo comparator | Other: neurofeedbackThis group will regulate a brain region by real-time functional magnetic resonance imaging that is not centrally involved in the visual snow syndrome |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurofeedback(based on real-time functional magnetic resonance signals) | Other | Patients group 1, Patients group 2 |
Primary outcome
symptom severity
Time frame: Acute after neurofeedback and 3 months after neurofeedback
Changes in symptom severity before and after real-time fMRI neurofeedback
1 secondary outcome
Magnetic resonance imaging
Time frame: before and immediately after the neurofeedback sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided. 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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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurofeedback in people with Visual Snow Syndrome and Neuro-Ophthalmology, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom severity (time frame: Acute after neurofeedback and 3 months after neurofeedback). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.