Transcranial Magnetic Stimulation For Visual Snow Syndrome (TMSVS)

May 9, 2023 updated by: University of Colorado, Denver

Transcranial Magnetic Stimulation for Visual Snow Syndrome: An Open-Label Feasibility Treatment Trial

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

Study Overview

Status

Completed

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One group
All participants will undergo 2 weeks (5 times each week) of repetitive TMS
Five days a week for 2 consecutive weeks, participants will have repetitive TMS at specific paramaters
Other Names:
  • TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1
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.
Week 2
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.
Month 1
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.
Month 3
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.
Week 1
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.
Week 2
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.
Month 1
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.
Month 3
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
Week 1
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
Week 2
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
Month 1
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
Month 3
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.
Week 1
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.
Week 2
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.
Month 1
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.
Month 3
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.
Week 1
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.
Week 2
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.
Month 1
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.
Month 3
Drop out rate
Time Frame: Month 3
The number of participants who drop out will be determined at the end of the study.
Month 3
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.
Week 1
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.
Week 2
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.
Month 1
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.
Month 3
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.
Week 1
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.
Week 2
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.
Month 1
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.
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Principal Investigator, CU School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protocol will be published

Drug and device information, study documents

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

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.

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