Visual Snow SyndromeNCT06018103
MBCT-vision VSS RCT
A study testing MBCT-vision in people with Visual Snow Syndrome, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
Visual Snow Syndrome (VSS) is a neurological condition with bran network dysregulation involving the visual pathway. This is a research trial comparing the effect of an 8-week mindfulness-based intervention via a group-learning course, the MBCT-vision programme, to treat Visual Snow Syndrome, compared to people on a… Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Snow Syndrome
- What is being tested?
- MBCT-vision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- People with VSS according to the ICHD-3 criteria; previously diagnosed by a Neurologist, Ophthalmologist or Neuro-Ophthalmologist
Who cannot join
- Patients with co-morbid conditions affecting vision
- Patients with a current severe depressive or psychotic episode as determined by the psychologist
- Patients with severe difficulties in emotional regulation as determined by the psychologist
- Patients unable to provide informed consent for participation
- Patients with insufficient understanding of spoken English (due to need to participate in group discussions)
- Patients who have previously completed MBCT or similar mindfulness interventions
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- Persons aged <16 or >80 years
- An exploratory sub-study on the change in metabolomics will recruit healthy controls, inclusion criteria:
- Healthy Control Inclusion Criteria
- Family or household member of a similar age (+/- 8years) to a participant with VSS recruited into the MBCT-vision VSS RCT study
- Person with no symptoms of VSS
- Person who self-declares as fit and well with no current medical conditions including anxiety or migraine
- Healthy Control Exclusion Criteria
- Person unable to provide informed consent
- Person with other co-morbid medical or psychological conditions
- Person aged <16 or >80years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MBCT-vision to Treat Visual Snow Syndrome: a Randomized Controlled Trial
Visual Snow Syndrome (VSS) is a neurological condition with bran network dysregulation involving the visual pathway. This is a research trial comparing the effect of an 8-week mindfulness-based intervention via a group-learning course, the MBCT-vision programme, to treat Visual Snow Syndrome, compared to people on a standard care (wait-list control). Participants will be randomly allocated to either the Treatment group (MBCT-vision), or the Control group (wait-list control). After a waiting period, people allocated to the Control group will also be offered the MBCT-vision treatment. The primary outcome is to compare the severity of the visual symptoms on a 0 to 10 scale between the two groups.
Read the detailed description
Visual Snow Syndrome (VSS) is a neurological condition where affected people see flickering dots across their whole visual field, \& may have other symptoms such as light sensitivity, after-images, trailing of images, \& tinnitus. Functional Magnetic Resonance Imaging (fMRI) studies in VSS have shown brain network dysregulation involving the visual pathway. There is currently no evidence-based validated treatment for VSS, therefore the current standard of care is no treatment.
This research trial is to test the treatment of an intensive mindfulness programme, using the Mindfulness Based Cognitive Therapy customised for visual symptoms (MBCT-vision) programme, for people with Visual Snow Syndrome. MBCT-vision is a group learning programme, where people meet once weekly for 8 weeks. During these once weekly sessions, they learn mindfulness practices. The group discussions about the mindfulness practices introduces cognitive behavioural skills. Participants are given daily home practices between these weekly group learning sessions. We completed a study (ClinicalTrials.gov identifier NCT04184726) showing MBCT-vision was a feasible treatment for VSS.
This clinical trial is a 'randomized controlled trial'(RCT), where the effectiveness of a treatment is evaluated by comparison between two groups. We are recruiting people with VSS. Participants will be randomly allocated to one of two groups: one group receives MBCT-vision; while another group received standard care only for 5 months. The second group is called a waiting-list control group, whereby after 5 months, they will receive MBCT-vision treatment. The study will be conducted from single centre at a tertiary care hospital and the MBCT-vision is delivered online.
The key outcome of interest is severity of Visual Snow Syndrome on a 0-10 visual analogue scale. Other outcome measures will be collected to understand the effect of MBCT-vision, including quality of life and psychological wellbeing.
- Conditions
- Visual Snow Syndrome
- Being tested
- MBCT-vision
- Keywords
- Visual Snow Syndrome, Mindfulness
- 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.
MBCT-visionBehavioural
8-week mindfulness group learning course, using Mindfulness Based Cognitive Therapy customised for visual symptoms (MBCT-vision). Participants meet once weekly only, with daily home practice between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 8-week online group learning course of the MBCT-vision programme Receives: Behavioral: MBCT-vision |
| Control | No intervention | wait-list control (standard care, no research intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of visual symptoms of Visual Snow Syndrome on a 0-10 VAS
Severity of VSS visual symptoms
Measured: 5 months
Secondary outcomes (4)
Psychological wellbeing on the World Health Organisation (WHO) wellbeing index scores
WHO-5 wellbeing index
Measured: 5 months
Psychological distress on the Clinical Outcomes in Routine Evaluation (CORE-10) scores
CORE-10 scores
Measured: 5-months
Impact of Visual Snow Syndrome symptoms on daily life on 0-10 scale
VSS impact
Measured: 5-months
Work and Social Adjustment Scale
impact of VSS on work and social function
Measured: 5-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study startJan 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2026 (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
- Randomized Control Trial of two groups: Treatment (MBCT-vision), or Control (wait-list, standard of care)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sui Wong, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018103
- Sponsor's protocol ID
- 328749
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: anonymised numeric data to be shared upon reasonable request from qualified researcher after review by Eye Research Governance and data transfer agreement
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MBCT-vision to Treat Visual Snow Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06018103
- Acronym / sponsor ID
- 328749
- Conditions
- Visual Snow Syndrome
- Keywords
- Visual Snow Syndrome, Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Aug 2023 (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 Syndrome (VSS) is a neurological condition with bran network dysregulation involving the visual pathway. This is a research trial comparing the effect of an 8-week mindfulness-based intervention via a group-learning course, the MBCT-vision programme, to treat Visual Snow Syndrome, compared to people on a standard care (wait-list control). Participants will be randomly allocated to either the Treatment group (MBCT-vision), or the Control group (wait-list control). After a waiting period, people allocated to the Control group will also be offered the MBCT-vision treatment. The primary outcome is to compare the severity of the visual symptoms on a 0 to 10 scale between the two groups.
Detailed description
Visual Snow Syndrome (VSS) is a neurological condition where affected people see flickering dots across their whole visual field, \& may have other symptoms such as light sensitivity, after-images, trailing of images, \& tinnitus. Functional Magnetic Resonance Imaging (fMRI) studies in VSS have shown brain network dysregulation involving the visual pathway. There is currently no evidence-based validated treatment for VSS, therefore the current standard of care is no treatment.
This research trial is to test the treatment of an intensive mindfulness programme, using the Mindfulness Based Cognitive Therapy customised for visual symptoms (MBCT-vision) programme, for people with Visual Snow Syndrome. MBCT-vision is a group learning programme, where people meet once weekly for 8 weeks. During these once weekly sessions, they learn mindfulness practices. The group discussions about the mindfulness practices introduces cognitive behavioural skills. Participants are given daily home practices between these weekly group learning sessions. We completed a study (ClinicalTrials.gov identifier NCT04184726) showing MBCT-vision was a feasible treatment for VSS.
This clinical trial is a 'randomized controlled trial'(RCT), where the effectiveness of a treatment is evaluated by comparison between two groups. We are recruiting people with VSS. Participants will be randomly allocated to one of two groups: one group receives MBCT-vision; while another group received standard care only for 5 months. The second group is called a waiting-list control group, whereby after 5 months, they will receive MBCT-vision treatment. The study will be conducted from single centre at a tertiary care hospital and the MBCT-vision is delivered online.
The key outcome of interest is severity of Visual Snow Syndrome on a 0-10 visual analogue scale. Other outcome measures will be collected to understand the effect of MBCT-vision, including quality of life and psychological wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial of two groups: Treatment (MBCT-vision), or Control (wait-list, standard of care)
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: MBCT-vision8-week online group learning course of the MBCT-vision programme |
| Control | No intervention | –wait-list control (standard care, no research intervention) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People with VSS according to the ICHD-3 criteria; previously diagnosed by a Neurologist, Ophthalmologist or Neuro-Ophthalmologist
Key exclusion criteria (16 listed)
- Patients with co-morbid conditions affecting vision
- Patients with a current severe depressive or psychotic episode as determined by the psychologist
- Patients with severe difficulties in emotional regulation as determined by the psychologist
- Patients unable to provide informed consent for participation
- Patients with insufficient understanding of spoken English (due to need to participate in group discussions)
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 |
|---|---|---|
| MBCT-vision8-week mindfulness group learning course, using Mindfulness Based Cognitive Therapy customised for visual symptoms (MBCT-vision). Participants meet once weekly only, with daily home practice between sessions. | Behavioural | Treatment |
Primary outcome
Severity of visual symptoms of Visual Snow Syndrome on a 0-10 VAS
Time frame: 5 months
Severity of VSS visual symptoms
4 secondary outcomes
Psychological wellbeing on the World Health Organisation (WHO) wellbeing index scores
Time frame: 5 months
Psychological distress on the Clinical Outcomes in Routine Evaluation (CORE-10) scores
Time frame: 5-months
Impact of Visual Snow Syndrome symptoms on daily life on 0-10 scale
Time frame: 5-months
Work and Social Adjustment Scale
Time frame: 5-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No. anonymised numeric data to be shared upon reasonable request from qualified researcher after review by Eye Research Governance and data transfer agreement
Related trials for Visual Snow Syndrome
Recruiting
Investigating Brain Function in People With and Without Visual Snow Syndrome Using Adaptation to Visual Stimuli
Visual Snow Syndrome, Migraine
RecruitingObservational study
High-field MR Imaging in Migraine, Visual Snow and Epilepsy
Migraine, Epilepsy
Recruiting
Study of Visual Perception Phenomena: Phosphene Mapping Induced by TMS and Its Relationship With Eye Movements
Visual Snow Syndrome, Color Blindness
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.
Sui Wong, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing MBCT-vision in people with Visual Snow Syndrome, run by Guy's and St Thomas' NHS Foundation Trust.
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 1 inclusion and 16 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: opening soon, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sui Wong, MD (020 7188 4885, research@MBCT-vision.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of visual symptoms of Visual Snow Syndrome on a 0-10 VAS (time frame: 5 months). 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 31 Aug 2023; AzTrials last refreshed its copy on 27 Oct 2026.