Visual Snow SyndromeTMSVSNCT04925232
Transcranial Magnetic Stimulation For Visual Snow Syndrome
A study testing Transcranial Magnetic Stimulation device in people with Visual Snow Syndrome, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Snow Syndrome
- What is being tested?
- Transcranial Magnetic Stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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…)
Who cannot join
- 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
Show all 10Show fewer
- Unstable cardiac, pulmonary, or other systemic illness
- Pregnancy
- Bipolar disorder
- History of suicidality
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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).
Read the 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:
- 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.
- Determine the performance of a novel scale (Colorado Visual Snow Scale) and two three psychophysical visual processing tasks
- Determine the standard deviation and test-retest reliability for the novel scale and two visual processing tasks
- Determine whether the visual processing tasks perform similar to performance found by the developer
- Describe changes in outcome measures between pre- and post-treatment with rTMS
- Conditions
- Visual Snow Syndrome
- Being tested
- Transcranial Magnetic Stimulation device
- Keywords
- repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- visual snow syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation deviceDevice
Also called TMS
Five days a week for 2 consecutive weeks, participants will have repetitive TMS at specific paramaters
| Study group | Role | What they receive |
|---|---|---|
| One group | Experimental | All participants will undergo 2 weeks (5 times each week) of repetitive TMS Receives: Device: Transcranial Magnetic Stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMS Side Effect Questionnaire
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.
Measured: Week 1
TMS Side Effect Questionnaire
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.
Measured: Week 2
TMS Side Effect Questionnaire
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.
Measured: Month 1
TMS Side Effect Questionnaire
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.
Measured: Month 3
Visual Noise Task
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.
Measured: Week 1
Visual Noise Task
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.
Measured: Week 2
Visual Noise Task
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.
Measured: Month 1
Visual Noise Task
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.
Measured: Month 3
Visual Contrast Task
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
Measured: Week 1
Visual Contrast Task
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
Measured: Week 2
Visual Contrast Task
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
Measured: Month 1
Visual Contrast Task
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
Measured: Month 3
Global Motion Task
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.
Measured: Week 1
Global Motion Task
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.
Measured: Week 2
Global Motion Task
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.
Measured: Month 1
Global Motion Task
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.
Measured: Month 3
Colorado Visual Snow Symptom Scale
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.
Measured: Week 1
Colorado Visual Snow Symptom Scale
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.
Measured: Week 2
Colorado Visual Snow Symptom Scale
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.
Measured: Month 1
Colorado Visual Snow Symptom Scale
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.
Measured: Month 3
Drop out rate
The number of participants who drop out will be determined at the end of the study.
Measured: Month 3
Visual Functional Quality Scale (VFQ-25)
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.
Measured: Week 1
Visual Functional Quality Scale (VFQ-25)
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.
Measured: Week 2
Visual Functional Quality Scale (VFQ-25)
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.
Measured: Month 1
Visual Functional Quality Scale (VFQ-25)
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.
Measured: Month 3
General Anxiety Disorder Scale (GAD-7)
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.
Measured: Week 1
General Anxiety Disorder Scale (GAD-7)
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.
Measured: Week 2
General Anxiety Disorder Scale (GAD-7)
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.
Measured: Month 1
General Anxiety Disorder Scale (GAD-7)
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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Aug 2019
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual Snow SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, CU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925232
- Sponsor's protocol ID
- 20-0424
- Acronym
- TMSVS
- Status last verified
- May 2023
- First submitted
- 17 May 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Protocol will be published
Publications
Grande M, Lattanzio L, Buard I, McKendrick AM, Chan YM, Pelak VS. A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation. Front Neurol. 2021 Sep 24;12:724081. doi: 10.3389/fneur.2021.724081. eCollection 2021.
PubMed 34630299
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation for Visual Snow Syndrome: An Open-Label Feasibility Treatment Trial
- ClinicalTrials.gov ID
- NCT04925232
- Acronym / sponsor ID
- TMSVS / 20-0424
- Conditions
- Visual Snow Syndrome
- Keywords
- repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the feasibility of the use of repetitive transcranial magnetic stimulation (rTMS) for symptoms associated with Visual Snow syndrome (VS).
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:
- 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.
- Determine the performance of a novel scale (Colorado Visual Snow Scale) and two three psychophysical visual processing tasks
- Determine the standard deviation and test-retest reliability for the novel scale and two visual processing tasks
- Determine whether the visual processing tasks perform similar to performance found by the developer
- Describe changes in outcome measures between pre- and post-treatment with rTMS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | Experimental | Device: Transcranial Magnetic Stimulation deviceAll participants will undergo 2 weeks (5 times each week) of repetitive TMS |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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…)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation deviceAlso: TMSFive days a week for 2 consecutive weeks, participants will have repetitive TMS at specific paramaters | Device | One group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
Drop out rate
Time frame: Month 3
The number of participants who drop out will be determined at the end of the study.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 34630299Grande M, Lattanzio L, Buard I, McKendrick AM, Chan YM, Pelak VS. A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation. Front Neurol. 2021 Sep 24;12:724081. doi: 10.3389/fneur.2021.724081. eCollection 2021.
- Individual participant dataSharing planned: No. Protocol will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator principal investigator
CU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation device in people with Visual Snow Syndrome, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMS Side Effect Questionnaire (time frame: Week 1). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.