Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT06018103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-31
First Post:
2023-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MBCT-vision VSS RCT
Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Organization:
Study Overview
Official Title:
MBCT-vision to Treat Visual Snow Syndrome: a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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-visionÍž 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.
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-visionÍž 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: