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Transcranial Magnetic Stimulation For Visual Snow Syndrome (TMSVS)

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ClinicalTrials.gov Identifier: NCT04925232
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study aims to investigate the feasibility of the use of repetitive transcranial magnetic stimulation (rTMS) for symptoms associated with Visual Snow syndrome (VS).

Condition or disease Intervention/treatment Phase
Visual Snow Syndrome Device: Transcranial Magnetic Stimulation device Not Applicable

Detailed Description:

The study will gather information about the treatment of up to 10 people with VS using rTMS. Treated participants will undergo 10 sessions of rTMS administered 5 times a week over 2 weeks. All visits will take place in the University of Colorado School of Medicine NeuroMag/Transcranial Magnetic Stimulation laboratory on University of Colorado Anschutz Medical Campus.

The specific aims for this feasibility study include:

  1. Determine whether any participant experiences untoward effects of rTMS in the setting of visual snow syndrome and determine the potential drop-out rate of larger study.
  2. Determine the performance of a novel scale (Colorado Visual Snow Scale) and two three psychophysical visual processing tasks

    1. Determine the standard deviation and test-retest reliability for the novel scale and two visual processing tasks
    2. Determine whether the visual processing tasks perform similar to performance found by the developer
  3. Describe changes in outcome measures between pre- and post-treatment with rTMS

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation for Visual Snow Syndrome: An Open-Label Feasibility Treatment Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: One group
All participants will undergo 2 weeks (5 times each week) of repetitive TMS
Device: Transcranial Magnetic Stimulation device
Five days a week for 2 consecutive weeks, participants will have repetitive TMS at specific paramaters
Other Name: TMS




Primary Outcome Measures :
  1. TMS Side Effect Questionnaire [ Time Frame: Week 1 ]
    The TMS Side Effect Questionnaire queries participants for specific and potential side effects related to TMS. It also allows for open ended answers regarding potential side effects from TMS. The percent of participants experiencing adverse events directly related to treatment will be reported.

  2. TMS Side Effect Questionnaire [ Time Frame: Week 2 ]
    The TMS Side Effect Questionnaire queries participants for specific and potential side effects related to TMS. It also allows for open ended answers regarding potential side effects from TMS.The percent of participants experiencing adverse events directly related to treatment will be reported.

  3. TMS Side Effect Questionnaire [ Time Frame: Month 1 ]
    The TMS Side Effect Questionnaire queries participants for specific and potential side effects related to TMS. It also allows for open ended answers regarding potential side effects from TMS.The percent of participants experiencing adverse events directly related to treatment will be reported.

  4. TMS Side Effect Questionnaire [ Time Frame: Month 3 ]
    The TMS Side Effect Questionnaire queries participants for specific and potential side effects related to TMS. It also allows for open ended answers regarding potential side effects from TMS. The percent of participants experiencing adverse events directly related to treatment will be reported.

  5. Visual Noise Task [ Time Frame: Week 1 ]
    This task will assess physiological properties of the visual system related to visual noise and will measure luminance increment detection threshold in a noise task with scores from 0-7, with higher scores considered poorer performance.

  6. Visual Noise Task [ Time Frame: Week 2 ]
    This task will assess physiological properties of the visual system related to visual noise and will measure luminance increment detection threshold in a noise task with scores from 0-7, with higher scores considered poorer performance.

  7. Visual Noise Task [ Time Frame: Month 1 ]
    This task will assess physiological properties of the visual system related to visual noise and will measure luminance increment detection threshold in a noise task with scores from 0-7, with higher scores considered poorer performance.

  8. Visual Noise Task [ Time Frame: Month 3 ]
    This task will assess physiological properties of the visual system related to visual noise and will measure luminance increment detection threshold in a noise task with scores from 0-7, with higher scores considered poorer performance.

  9. Visual Contrast Task [ Time Frame: Week 1 ]
    This task will assess physiological properties of the visual system related to contrast and will measure the suppression index for a center-surround suppression task with scores from -1.00 to +1.00, with lower scores considered poorer performance

  10. Visual Contrast Task [ Time Frame: Week 2 ]
    This task will assess physiological properties of the visual system related to contrast and will measure the suppression index for a center-surround suppression task with scores from -1.00 to +1.00, with lower scores considered poorer performance

  11. Visual Contrast Task [ Time Frame: Month 1 ]
    This task will assess physiological properties of the visual system related to contrast and will measure the suppression index for a center-surround suppression task with scores from -1.00 to +1.00, with lower scores considered poorer performance

  12. Visual Contrast Task [ Time Frame: Month 3 ]
    This task will assess physiological properties of the visual system related to contrast and will measure the suppression index for a center-surround suppression task with scores from -1.00 to +1.00, with lower scores considered poorer performance

  13. Global Motion Task [ Time Frame: Week 1 ]
    Each test will assess physiological properties of the visual system related to global motion and measure pattern coherence threshold for global motion task with scores from 0.00 to 1.00, with higher thresholds considered poorer performance.

  14. Global Motion Task [ Time Frame: Week 2 ]
    Each test will assess physiological properties of the visual system related to global motion and measure pattern coherence threshold for global motion task with scores from 0.00 to 1.00, with higher thresholds considered poorer performance.

  15. Global Motion Task [ Time Frame: Month 1 ]
    Each test will assess physiological properties of the visual system related to global motion and measure pattern coherence threshold for global motion task with scores from 0.00 to 1.00, with higher thresholds considered poorer performance.

  16. Global Motion Task [ Time Frame: Month 3 ]
    Each test will assess physiological properties of the visual system related to global motion and measure pattern coherence threshold for global motion task with scores from 0.00 to 1.00, with higher thresholds considered poorer performance.

  17. Colorado Visual Snow Symptom Scale [ Time Frame: Week 1 ]
    Colorado Visual Snow Scale is a novel scale created for this study and to investigate its use in measure symptom severity. There are 11 subscales: Visual Static, Afterimages, Trails, Blue Field Entoptic Phenomenon, Floaters, Night Vision Problems, Tinnitus, Feeling of Detachment, Anxiety, Depression, Sleep Issues. Each section assess symptom severe, impact on vision, impact on daily activities, and ability to drive with scale of 0-10 wiht 10 being more severe or impairing the symptom. Total score for each subscale can range from 0-40 and total score overall can range from 0-440 and the higher the score the more severe or impairing the symptoms.

  18. Colorado Visual Snow Symptom Scale [ Time Frame: Week 2 ]
    Colorado Visual Snow Scale is a novel scale created for this study and to investigate its use in measure symptom severity. There are 11 subscales: Visual Static, Afterimages, Trails, Blue Field Entoptic Phenomenon, Floaters, Night Vision Problems, Tinnitus, Feeling of Detachment, Anxiety, Depression, Sleep Issues. Each section assess symptom severe, impact on vision, impact on daily activities, and ability to drive with scale of 0-10 wiht 10 being more severe or impairing the symptom. Total score for each subscale can range from 0-40 and total score overall can range from 0-440 and the higher the score the more severe or impairing the symptoms.

  19. Colorado Visual Snow Symptom Scale [ Time Frame: Month 1 ]
    Colorado Visual Snow Scale is a novel scale created for this study and to investigate its use in measure symptom severity. There are 11 subscales: Visual Static, Afterimages, Trails, Blue Field Entoptic Phenomenon, Floaters, Night Vision Problems, Tinnitus, Feeling of Detachment, Anxiety, Depression, Sleep Issues. Each section assess symptom severe, impact on vision, impact on daily activities, and ability to drive with scale of 0-10 wiht 10 being more severe or impairing the symptom. Total score for each subscale can range from 0-40 and total score overall can range from 0-440 and the higher the score the more severe or impairing the symptoms.

  20. Colorado Visual Snow Symptom Scale [ Time Frame: Month 3 ]
    Colorado Visual Snow Scale is a novel scale created for this study and to investigate its use in measure symptom severity. There are 11 subscales: Visual Static, Afterimages, Trails, Blue Field Entoptic Phenomenon, Floaters, Night Vision Problems, Tinnitus, Feeling of Detachment, Anxiety, Depression, Sleep Issues. Each section assess symptom severe, impact on vision, impact on daily activities, and ability to drive with scale of 0-10 wiht 10 being more severe or impairing the symptom. Total score for each subscale can range from 0-40 and total score overall can range from 0-440 and the higher the score the more severe or impairing the symptoms.

  21. Drop out rate [ Time Frame: Month 3 ]
    The number of participants who drop out will be determined at the end of the study.

  22. Visual Functional Quality Scale (VFQ-25) [ Time Frame: Week 1 ]
    The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ) and it is useful in clinical trials to measure quality of visual functioning. Scores range from 0-100 with higher scores indicating better quality visual functioning in everyday activities.

  23. Visual Functional Quality Scale (VFQ-25) [ Time Frame: Week 2 ]
    The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ) and it is useful in clinical trials to measure quality of visual functioning. Scores range from 0-100 with higher scores indicating better quality visual functioning in everyday activities.

  24. Visual Functional Quality Scale (VFQ-25) [ Time Frame: Month 1 ]
    The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ) and it is useful in clinical trials to measure quality of visual functioning. Scores range from 0-100 with higher scores indicating better quality visual functioning in everyday activities.

  25. Visual Functional Quality Scale (VFQ-25) [ Time Frame: Month 3 ]
    The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ) and it is useful in clinical trials to measure quality of visual functioning. Scores range from 0-100 with higher scores indicating better quality visual functioning in everyday activities.

  26. General Anxiety Disorder Scale (GAD-7) [ Time Frame: Week 1 ]
    Screening questionnaire that measures the degree of anxiety with scores ranging from 0-21 and higher scores indicate greater anxiety. Scores of 5, 10, and 15 can be interpreted as representing mild, moderate, and severe levels of anxiety.

  27. General Anxiety Disorder Scale (GAD-7) [ Time Frame: Week 2 ]
    Screening questionnaire that measures the degree of anxiety with scores ranging from 0-21 and higher scores indicate greater anxiety. Scores of 5, 10, and 15 can be interpreted as representing mild, moderate, and severe levels of anxiety.

  28. General Anxiety Disorder Scale (GAD-7) [ Time Frame: Month 1 ]
    Screening questionnaire that measures the degree of anxiety with scores ranging from 0-21 and higher scores indicate greater anxiety. Scores of 5, 10, and 15 can be interpreted as representing mild, moderate, and severe levels of anxiety.

  29. General Anxiety Disorder Scale (GAD-7) [ Time Frame: Month 3 ]
    Screening questionnaire that measures the degree of anxiety with scores ranging from 0-21 and higher scores indicate greater anxiety. Scores of 5, 10, and 15 can be interpreted as representing mild, moderate, and severe levels of anxiety.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A diagnosis of VS that meets International Headache Society criteria
  • Able to provide meaningful informed consent
  • Visual snow must be present for more than three months and must be persistent (i.e. continuous)
  • A prior clinical Brain MRI with and without contrast done in the past 3 years that does not show signs of clinically significant brain lesions (no evidence of multiple sclerosis, stroke, brain tumor, cortical heterotopia or other cortical developmental abnormalities, arteriovenous malformation, etc…)

Exclusion Criteria:

  • Syndrome meeting criteria for Hallucinogen-persisting perception disorder
  • Prior treatment with TMS for any disorder
  • Epilepsy, family history of epilepsy, or personal history of seizure
  • Any medical condition or medication that increases the risk of seizure
  • Pacemaker or other implantable medical device
  • Metal in the skull, not including the mouth
  • Unstable cardiac, pulmonary, or other systemic illness
  • Pregnancy
  • Bipolar disorder
  • History of suicidality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925232


Contacts
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Contact: Visual Snow Study Coordinator 303-724-4644 VisualSnowColorado@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado School of Medicine Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Visual Snow Study Coordinator    303-724-4644    VisualSnowColorado@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Principal Investigator CU School of Medicine
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04925232    
Other Study ID Numbers: 20-0424
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Protocol will be published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Colorado, Denver:
repetitive Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes