- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06018103
MBCT-vision VSS RCT
MBCT-vision to Treat Visual Snow Syndrome: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sui Wong, MD
- Phone Number: 020 7188 4885
- Email: research@MBCT-vision.co.uk
Study Contact Backup
- Name: Abigail Orr
- Phone Number: 020 7188 4885
- Email: EyeResearch@gstt.nhs.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- People with VSS according to the ICHD-3 criteria; previously diagnosed by a Neurologist, Ophthalmologist or Neuro-Ophthalmologist
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
8-week online group learning course of the MBCT-vision programme
|
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.
|
No Intervention: Control
wait-list control (standard care, no research intervention)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of visual symptoms of Visual Snow Syndrome on a 0-10 VAS
Time Frame: 5 months
|
Severity of VSS visual symptoms
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological wellbeing on the World Health Organisation (WHO) wellbeing index scores
Time Frame: 5 months
|
WHO-5 wellbeing index
|
5 months
|
Psychological distress on the Clinical Outcomes in Routine Evaluation (CORE-10) scores
Time Frame: 5-months
|
CORE-10 scores
|
5-months
|
Impact of Visual Snow Syndrome symptoms on daily life on 0-10 scale
Time Frame: 5-months
|
VSS impact
|
5-months
|
Work and Social Adjustment Scale
Time Frame: 5-months
|
impact of VSS on work and social function
|
5-months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sui Wong, MD, Guy's and St Thomas' NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 328749
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Visual Snow Syndrome
-
University of ZurichUSZ FoundationActive, not recruiting
-
University of Colorado, DenverCompletedVisual Snow SyndromeUnited States
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Fondation Ophtalmologique Adolphe de RothschildWithdrawnVisual Snow SyndromeFrance
-
Guy's and St Thomas' NHS Foundation TrustCompletedVisual Snow Syndrome | Photophobia | Trailing Phenomenon | Visual AuraUnited Kingdom
-
University of UlsterEnrolling by invitationVisual Stress | Meares-Irlen Syndrome | Reading DifficultiesUnited Kingdom
-
Czech Technical University in PragueCharles University, Czech Republic; Ministry of Defence and Armed Forces of...UnknownSnow Properties and Its Modeling for Studying Gas Exchange Under the Simulated Avalanche Snow (SPAM)Accident Caused by Snow AvalancheCzechia
-
Haukeland University HospitalUllevaal University HospitalUnknownAccident Caused by Snow AvalancheNorway
-
Czech Technical University in PragueCharles University, Czech RepublicCompletedAccident Caused by Snow AvalancheCzech Republic
-
Czech Technical University in PragueEnrolling by invitationAccident Caused by Snow AvalancheCzechia
Clinical Trials on MBCT-vision
-
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British Columbia Children's HospitalActive, not recruiting
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University of WashingtonNational Multiple Sclerosis SocietyActive, not recruiting
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Clemson UniversityPrisma Health-UpstateRecruitingMajor Depressive DisorderUnited States
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Mount Sinai Hospital, CanadaCompleted
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University of Colorado, BoulderNational Institute of Mental Health (NIMH); Emory University; Kaiser PermanenteCompletedDepression | Postpartum Depression | PregnancyUnited States