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

Marissa Grande, Lucas Lattanzio, Isabelle Buard, Allison M McKendrick, Yu Man Chan, Victoria S Pelak, Marissa Grande, Lucas Lattanzio, Isabelle Buard, Allison M McKendrick, Yu Man Chan, Victoria S Pelak

Abstract

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.

Keywords: migraine; open-label treatment trial; transcranial magnetic stimulation; visual psychophysics; visual snow.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Grande, Lattanzio, Buard, McKendrick, Chan and Pelak.

References

    1. Lauschke JL, Plant GT, Fraser CL. Visual snow: a thalamocortical dysrhythmia of the visual pathway?. J Clin Neurosci. (2016) 28:123–7. 10.1016/j.jocn.2015.12.001
    1. Schankin CJ, Maniyar FH, Sprenger T, Chou DE, Eller M, Goadsby PJ. The relation between migraine, typical migraine aura and ‘visual snow. Headache. (2014) 54:957–66. 10.1111/head.12378
    1. Headache Classification Committee of the International Headache Society . The international classification of headache disorders, 3rd edition. Cephalalgia. (2018) 38:1–211. 10.1177/0333102417738202
    1. Bou Ghannam A, Pelak VS. Visual snow: a potential cortical hyperexcitability syndrome. Curr Treat Options Neurol. (2017) 19:448. 10.1007/s11940-017-0448-3
    1. Schankin CJ, Maniyar FH, Digre KB, Goadsby PJ. Visual snow' – a disorder distinct from persistent migraine aura. Brain. (2014) 137:1419–28. 10.1093/brain/awu050
    1. van Dun K, Bodranghien F, Manto M, Mariën P. Targeting the cerebellum by noninvasive neurostimulation: a review. Cerebellum. (2016) 16:695–741. 10.1007/s12311-016-0840-7
    1. Khedr EM. Longlasting antalgic effects of daily sessions of repetitive transcranial magnetic stimulation in central and peripheral neuropathic pain. J Neurol Neurosurg Psychiatry. (2005) 76:833–8. 10.1136/jnnp.2004.055806
    1. Misra UK, Kalita J, Bhoi SK. High-rate repetitive transcranial magnetic stimulation in migraine prophylaxis: a randomized, placebo-controlled study. J Neurol. (2013) 260:2793–801. 10.1007/s00415-013-7072-2
    1. Food US and Drug Administration . FDA Permits Marketing of Transcranial Magnetic Stimulation for Treatment of Obsessive Compulsive Disorder. (2021). Available online at: (accessed May 31, 2021).
    1. Eichhammer P, Kleinjung T, Landgrebe M, Hajak G, Langguth B. TMS for treatment of chronic tinnitus — neurobiological effects. Tinnitus. (2007) 169:369–75. 10.1016/s0079-6123(07)66035-x
    1. Klomjai W, Katz R, Lackmy-Vallée A. Basic principles of transcranial magnetic stimulation (TMS) and repetitive TMS (RTMS). Ann Phys Rehabil Med. (2015) 58:208–13. 10.1016/j.rehab.2015.05.005
    1. Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Lazzaro VD, et al. . Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (RTMS): an update (2014–2018). Clin Neurophysiol. (2020) 131:474–528. 10.1016/j.clinph.2019.11.002
    1. Bliss TVP, Cooke SF. Long-term potentiation and long-term depression: a clinical perspective. Clinics. (2011) 66:3–17. 10.1590/s1807-59322011001300002
    1. Chen R, Gerloff C, Classen J, Wassermann EM, Hallett M, Cohen LG. Safety of different inter-train intervals for repetitive transcranial magnetic stimulation and recommendations for safe ranges of stimulation parameters. Electroencephalogr Clin Neurophysiol. (1997) 105:415–21. 10.1016/s0924-980x(97)00036-2
    1. Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. (2009) 120:2008–39. 10.1016/j.clinph.2009.08.016
    1. Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the international workshop on the safety of repetitive transcranial magnetic stimulation, June 5–7, 1996. Electroencephalograp Clin Neurophysiol. (1998) 108:1–16. 10.1016/s0168-5597(97)00096-8
    1. McKendrick AM, Chan YM, Tien M, Millist L, Clough M, Mack H, et al. . Behavioral measures of cortical hyperexcitability assessed in people who experience visual snow. Neurology. (2017) 88:1243–9. 10.1212/wnl.0000000000003784
    1. McKendrick AM, Chan YM, Vingrys AJ, Turpin A, Badcock DR. Daily vision testing can expose the prodromal phase of migraine. Cephalalgia. (2017) 38:1575–84. 10.1177/0333102417741130
    1. Stewart LM, Walsh V, Rothwell JC. Motor and phosphene thresholds: A transcranial magnetic stimulation correlation study. Neuropsychologia. (2001) 39:415–9. 10.1016/s0028-3932(00)00130-5
    1. Lage C, Wiles K, Shergill SS, Tracy DK. A systematic review of the effects of low-frequency repetitive transcranial magnetic stimulation on cognition. J Neural Transm. (2016) 123:1479–90. 10.1007/s00702-016-1592-8
    1. Kleinjung T, Eichhammer P, Langguth B, Jacob P, Marienhagen J, Hajak G, et al. . Long-term effects of repetitive transcranial magnetic stimulation (rtms) in patients with chronic tinnitus. Otolaryngology. (2005) 132:566–9. 10.1016/j.otohns.2004.09.134
    1. Saunders JC. The role of central nervous system plasticity in tinnitus. J Commun Disord. (2007) 40:313–34. 10.1016/j.jcomdis.2007.03.006
    1. Canavero S, Bonicalzi V. Central pain syndrome: elucidation of genesis and treatment. Expert Rev Neurother. (2007) 7:1485–97. 10.1586/14737175.7.11.1485

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