A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation

Background: Visual Snow (VS) syndrome is believed to be due to aberrant central visual processing. Positron Emission Tomography (PET) brain imaging and visual evoked potential studies provide evidence for excessive neuronal activity in the medial temporal lobe, specifically the lingual gyrus, and su...

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Main Authors: Marissa Grande, Lucas Lattanzio, Isabelle Buard, Allison M. McKendrick, Yu Man Chan, Victoria S. Pelak
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-09-01
Series:Frontiers in Neurology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fneur.2021.724081/full
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author Marissa Grande
Lucas Lattanzio
Isabelle Buard
Allison M. McKendrick
Yu Man Chan
Victoria S. Pelak
Victoria S. Pelak
author_facet Marissa Grande
Lucas Lattanzio
Isabelle Buard
Allison M. McKendrick
Yu Man Chan
Victoria S. Pelak
Victoria S. Pelak
author_sort Marissa Grande
collection DOAJ
description Background: Visual Snow (VS) syndrome is believed to be due to aberrant central visual processing. Positron Emission Tomography (PET) brain imaging and visual evoked potential studies provide evidence for excessive neuronal activity in the medial temporal lobe, specifically the lingual gyrus, and suggest the VS syndrome is a hyperexcitability syndrome. These data provide the basis for consideration of repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for the VS syndrome.Objective: To publish the study protocol for a pilot study underway at the University of Colorado School of Medicine to investigate the use of rTMS intervention to improve symptoms and visual dysfunction associated with VS. The study aims to determine the adverse events and drop-out rate, evaluate performance of outcome measures, including a novel VS symptom scale, and describe changes in outcomes associated with treatment.Methods and Design: Up to 10 participants meeting criteria for VS syndrome, age 19–65 years, will undergo an open-label intervention consisting of 10 rTMS sessions, occurring 5 days a week over a 2-week period. Participants will complete pre-treatment and post-treatment assessments that include: the Colorado Visual Snow Scale (CVSS), the National Eye Institute Visual Functional Questionnaire—25 (VFQ-25), the General Anxiety Disorder—7 scale (GAD-7), and three psychophysical visual processing tasks.Discussion: Knowledge gained from this pilot study will inform future study planning and provide valuable lessons for future investigation of rTMS for the VS syndrome. An overview of study proceedings thus far demonstrates recruitment challenges associated with the COVID-19 pandemic, and additional challenges that are unique to the VS syndrome and to treatment schedules associated with TMS.Registration: This study has been approved by the Colorado Multiple Institutional Review Board. ClinicalTrials.gov Identifier: NCT04925232.
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spelling doaj.art-8e01eb05134949e0b6816758defe96eb2022-12-21T22:33:34ZengFrontiers Media S.A.Frontiers in Neurology1664-22952021-09-011210.3389/fneur.2021.724081724081A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic StimulationMarissa Grande0Lucas Lattanzio1Isabelle Buard2Allison M. McKendrick3Yu Man Chan4Victoria S. Pelak5Victoria S. Pelak6Department of Neurology, University of Colorado, Aurora, CO, United StatesDepartment of Neurology, University of Colorado, Aurora, CO, United StatesDepartment of Neurology, University of Colorado, Aurora, CO, United StatesDepartment of Optometry and Vision Sciences, University of Melbourne, Melbourne, VIC, AustraliaDepartment of Optometry and Vision Sciences, University of Melbourne, Melbourne, VIC, AustraliaDepartment of Neurology, University of Colorado, Aurora, CO, United StatesDepartment of Ophthalmology, University of Colorado, Aurora, CO, United StatesBackground: Visual Snow (VS) syndrome is believed to be due to aberrant central visual processing. Positron Emission Tomography (PET) brain imaging and visual evoked potential studies provide evidence for excessive neuronal activity in the medial temporal lobe, specifically the lingual gyrus, and suggest the VS syndrome is a hyperexcitability syndrome. These data provide the basis for consideration of repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for the VS syndrome.Objective: To publish the study protocol for a pilot study underway at the University of Colorado School of Medicine to investigate the use of rTMS intervention to improve symptoms and visual dysfunction associated with VS. The study aims to determine the adverse events and drop-out rate, evaluate performance of outcome measures, including a novel VS symptom scale, and describe changes in outcomes associated with treatment.Methods and Design: Up to 10 participants meeting criteria for VS syndrome, age 19–65 years, will undergo an open-label intervention consisting of 10 rTMS sessions, occurring 5 days a week over a 2-week period. Participants will complete pre-treatment and post-treatment assessments that include: the Colorado Visual Snow Scale (CVSS), the National Eye Institute Visual Functional Questionnaire—25 (VFQ-25), the General Anxiety Disorder—7 scale (GAD-7), and three psychophysical visual processing tasks.Discussion: Knowledge gained from this pilot study will inform future study planning and provide valuable lessons for future investigation of rTMS for the VS syndrome. An overview of study proceedings thus far demonstrates recruitment challenges associated with the COVID-19 pandemic, and additional challenges that are unique to the VS syndrome and to treatment schedules associated with TMS.Registration: This study has been approved by the Colorado Multiple Institutional Review Board. ClinicalTrials.gov Identifier: NCT04925232.https://www.frontiersin.org/articles/10.3389/fneur.2021.724081/fullvisual snowtranscranial magnetic stimulationopen-label treatment trialvisual psychophysicsmigraine
spellingShingle Marissa Grande
Lucas Lattanzio
Isabelle Buard
Allison M. McKendrick
Yu Man Chan
Victoria S. Pelak
Victoria S. Pelak
A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation
Frontiers in Neurology
visual snow
transcranial magnetic stimulation
open-label treatment trial
visual psychophysics
migraine
title A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation
title_full A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation
title_fullStr A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation
title_full_unstemmed A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation
title_short A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation
title_sort study protocol for an open label feasibility treatment trial of visual snow syndrome with transcranial magnetic stimulation
topic visual snow
transcranial magnetic stimulation
open-label treatment trial
visual psychophysics
migraine
url https://www.frontiersin.org/articles/10.3389/fneur.2021.724081/full
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