Clinical trial NCT04925232: Transcranial Magnetic Stimulation For Visual Snow Syndrome
Official title: Transcranial Magnetic Stimulation for Visual Snow Syndrome: An Open-Label Feasibility Treatment Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Snow Syndrome
Keywords: repetitive Transcranial Magnetic Stimulation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Eligibility 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

Primary outcomes:
measure: TMS Side Effect Questionnaire
timeFrame: Week 1
measure: TMS Side Effect Questionnaire
timeFrame: Week 2
measure: TMS Side Effect Questionnaire
timeFrame: Month 1
measure: TMS Side Effect Questionnaire
timeFrame: Month 3
measure: Visual Noise Task
timeFrame: Week 1
measure: Visual Noise Task
timeFrame: Week 2
measure: Visual Noise Task
timeFrame: Month 1
measure: Visual Noise Task
timeFrame: Month 3
measure: Visual Contrast Task
timeFrame: Week 1
measure: Visual Contrast Task
timeFrame: Week 2
measure: Visual Contrast Task
timeFrame: Month 1
measure: Visual Contrast Task
timeFrame: Month 3
measure: Global Motion Task
timeFrame: Week 1
measure: Global Motion Task
timeFrame: Week 2
measure: Global Motion Task
timeFrame: Month 1
measure: Global Motion Task
timeFrame: Month 3
measure: Colorado Visual Snow Symptom Scale
timeFrame: Week 1
measure: Colorado Visual Snow Symptom Scale
timeFrame: Week 2
measure: Colorado Visual Snow Symptom Scale
timeFrame: Month 1
measure: Colorado Visual Snow Symptom Scale
timeFrame: Month 3
measure: Drop out rate
timeFrame: Month 3
measure: Visual Functional Quality Scale (VFQ-25)
timeFrame: Week 1
measure: Visual Functional Quality Scale (VFQ-25)
timeFrame: Week 2
measure: Visual Functional Quality Scale (VFQ-25)
timeFrame: Month 1
measure: Visual Functional Quality Scale (VFQ-25)
timeFrame: Month 3
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Week 1
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Week 2
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Month 1
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: CU School of Medicine
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.