Status Update: TMS for Visual Snow Syndrome Study Led by Dr. Victoria Pelak, University of Colorado Research Team

Status Update: TMS for Visual Snow Syndrome Study Led by Dr. Victoria Pelak, University of Colorado Research Team

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On March 20th, 2019, the Visual Snow Initiative (VSI) presented a $125,000 check to the University of Colorado’s research team, led by Dr. Victoria Pelak, to fund their open-label pilot treatment trial (COMIRB #: 20-0424) involving transcranial magnetic stimulation (TMS/rTMS) for Visual Snow Syndrome (VSS). Transcranial magnetic stimulation (TMS)/repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has been shown to improve outcomes in several neurological disorders and chronic tinnitus. Dr. Pelak, Professor of Neurology and Ophthalmology in the Department of Neurology at the University of Colorado Anschutz Medical Campus and the study’s principal investigator, aimed to determine the effectiveness of rTMS intervention at improving symptoms, visual dysfunction, and quality of life for participants diagnosed with VSS. Dr. Pelak commented:

“Our neuro-visual research group at the University of Colorado School of Medicine is extremely grateful for the support and we are busy planning the research trial. Without the support of the Visual Snow Initiative, the trial would never be possible. We expect to have results after 18 months and we look forward to sharing the results with the scientific community.”

VSI announced that the University of Colorado research team’s study protocol has been published in Frontiers, “a publisher of peer-reviewed, open access, scientific journals currently active in science, technology, and medicine” (Frontiers Media). “A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation” was published on September 24th, 2021. This article detailed the study protocol for the pilot study, which was still underway at the University of Colorado School of Medicine.

“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.” (Grande, Lattanzio, Buard, McKendrick, Chan, and Pelak, 2021, Frontiers)

Researchers also revealed that the Covid-19 pandemic impacted their study and caused many challenges. As explained by principal investigator Dr. Pelak within the article, after its funding, the study faced numerous unforeseen problems due to the rise of the Covid-19 pandemic. (See the study for full details.)

As explained by researchers, the study faced unforeseen delays and “large challenges” due to the Covid-19 pandemic. Numerous critical aspects of the study were negatively impacted, some of which included the enrollment rate and the feasibility of in-person participation versus remote participation (due to imposed restrictions), as well as how this would alter the effectiveness of the methods employed. Moreover, potential participants reported the difficulty of traveling during the pandemic, particularly for those who live around the state and beyond. This was an issue for researchers as participation required treatment five days in a row for two weeks in a row. Some participants were also not able to take time off from work for daily visits Monday-Friday for two weeks. (The protocol was later adjusted to accommodate participants, so they could miss an occasional consecutive day.)

Additionally, some potential participants were not eligible because they had not had an MRI scan of the brain in the past 3 years, which was specified as an eligibility requirement for study participants before rTMS was performed. Thus, additional time was required for participants to have an updated MRI scan. Researchers worked to maintain the study and adjust to the pandemic, but ultimately had to continue with an extension of the study, which required more financial support to address several of these unforeseen complications mentioned above, including the salary support for the investigators. With these delays, researchers estimated they may be able to complete enrollment for the study by 2022.

“This open-label treatment trial of rTMS for VS syndrome is ongoing, and results will be used to inform the feasibility and utility of a future randomized, controlled trial of rTMS for VS syndrome. The greatest challenge faced in the ongoing study has been difficulty with recruitment during to the Covid-19 pandemic. However, with decreasing Covid-19 restrictions within the United States and the increase in Covid-19 vaccinations in Colorado, there is renewed interest in participation in the study by those previously screened. Given the recent progress to date, the current aim is to complete enrollment by June 2022.” (Grande, Lattanzio, Buard, McKendrick, Chan, and Pelak, 2021, Frontiers)

However, researchers still gleaned valuable insights from this experience that they would be able to apply to this ongoing study, as well as future studies. The publication of this protocol also made a valuable contribution to advancing VSS research, as any other interested researchers could now replicate or expand upon their protocol, which could be used to explore rTMS as a vehicle to improve quality of life and treat VSS symptoms.

Soon thereafter, VSI’s Director of Research, Vanessa Mora, published her brief interview with Dr. Pelak. “Current & Ongoing Visual Snow Syndrome Research and Insights By Dr. Victoria Pelak” shared her recently-published study protocol, observations, and recommendations for VSS patients to treat their symptoms.

Although it initially experienced notable delays due to the Covid-19 pandemic, as of 2024, the study is still ongoing. The results will ultimately be published once Dr. Pelak and her team have completed their research.

In July of 2023, “Repetitive TMS pilot trial for visual snow syndrome: Adverse event report” was published in Brain Stimulation. Dr. Pelak and her team had analyzed and finished the safety data, which was published as an abstract. As of January 2024, Dr. Pelak shared with VSI that their next step is to look at the study outcomes. This is what the University of Colorado research team is currently working on. Dr. Pelak said she anticipates there will be more information to come after Spring (March 19th-June 20th, 2024, in the United States).

As soon as we receive further updates, we will notify everyone via the VSI website, newsletter, and/or social media channels. Thank you so much to everyone for their patience and support along the way.

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