The VISIONS Study (Visual Snow Investigation of Noise in Sensory Processing): A Psychophysical Investigation of Visual Perception and Symptom Simulation in Augmented Reality.
We would like to invite you to participate in this research project which forms part of our visual snow syndrome research. Before you decide whether you want to take part, it is important for you to understand why the research is being done and what your participation will involve. Please take time to read the following information carefully and discuss it with others if you wish.
What is the purpose of the project?
The purpose of the project is to better understand how people with Visual Snow Syndrome (VSS) process visual information. We are particularly interested in how the brain filters out ‘visual noise’ and how this may differ from people without VSS. To study this, we will use computer-based visual tasks and an augmented reality (AR) simulation that recreates the experience of visual snow. Our aim is to learn more about the mechanisms that cause visual snow, which may help guide the development of future treatments. We are also interested in understanding the overlap and co-occurrence of VSS with synaesthesia, a perceptual phenomenon where a stimulation of one sensory or cognitive pathway leads to involuntary experiences in a second one. Furthermore, we will be trying to understand whether visual snow symptoms are also linked to visual imagery.
Why have I been invited to take part?
You are being invited to participate in this project because you either experience Visual Snow Syndrome or you do not, and we are looking for both groups of people to take part. By comparing people with VSS to people without it, we can better understand how the condition affects visual perception. Everyone taking part will be over 18 years old and meet the study’s safety requirements. You will be participating in this study upon meeting the following inclusion and exclusion criteria for your specific group.
Inclusion Criteria
Group 1: VSS participants
- Diagnosis of visual snow syndrome following the published criteria
- Aged >18 years.
- Able to provide written informed consent in English.
- Willing and able to comply with scheduled visit and trial procedures.
- No history of worsening of VSS with prior medications.
Group 2: Healthy volunteers
- Aged >18 years.
- Able to provide written informed consent in English.
- Willing and able to comply with scheduled visit and trial procedures.
- No concomitant diagnosis of VSS.
Exclusion Criteria
- History of significant neurological or psychiatric disease other than VSS.
- Regular use of recreational drugs (including but not limited to cannabis, stimulants, psychedelics, dissociatives, opioids, and synthetic designer substances).
- History of psychosis or psychological disease either (a) requiring ongoing psychoactive drugs, or (b) that the investigator has reason to believe will either affect the patient’s neural pathways or hinder the performance of the patient regarding the ability to successfully complete the tasks required of them according to the protocol.
- Any person unable to understand written or spoken English.
- Subjects unwilling to comply with scheduled visit.
- Subjects who are or have recently (last 30 days) been involved in any interventional clinical trial.
- Any other condition that in the opinion of the investigator would make the subject unsuitable for the study including pregnancy.
What will happen if I take part?
If you choose to take part in the project you will be invited for a single study visit lasting about 90 minutes. During this visit:
- We will first ask you some brief questions on your medical history to make sure it is safe for you to take part and to collect relevant information for the study.
- You will then complete visual computer tasks. In one task, you will watch moving shapes on a screen while keeping your eyes on a central point, and we will ask you to say whether you saw certain targets disappear.
- If you have Visual Snow Syndrome, you will also try an augmented reality (AR) session. This will allow you to adjust a simulation of visual snow so it looks similar to what you normally see.
- After the AR session, you will repeat the visual computer task. You will also be asked to complete a short symptom questionnaire and diary about your experience.
- Additionally, an online VVIQ (Vividness of Visual Imagery Questionnaire) Test will be done to measure visual imagination.
- Finally, you will be asked to complete a questionnaire and a computer task on synaesthesia symptoms.
There will be a 5–10-minute break between all tasks. You will also be able to take further breaks at any time, and if you feel uncomfortable or wish to stop, you can end the session immediately.
Participation will take place at King’s College London, in the Institute of Psychiatry Psychology & Neuroscience (IoPPN).
Do I have to take part?
Participation is completely voluntary. You should only take part if you want to and choosing not to take part will not disadvantage you in any way. Once you have read the information sheet, please contact us if you have any questions that will help you make a decision about taking part. If you decide to take part, we will ask you to sign a consent form and will give you a copy of this to keep.
Incentives
You will be compensated for your time in taking part with £25.
What are the possible risks of taking part?
Taking part in this study is considered low risk. Some participants with Visual Snow Syndrome may find that the visual tasks or augmented reality session make their symptoms feel a little worse for a short time, or that they cause mild eyestrain, dizziness, or headache. These effects are usually brief and settle once the task is stopped. You can take breaks at any time and stop the session if you feel uncomfortable. If this occurs, we will stop the task, remove any equipment and stabilize the environment providing a calm, quiet space. We will conduct a clinical check-in and a brief symptom assessment (0–10 scales for anxiety, VSS symptoms, nausea, headache). You will be offered rest until symptoms settle. If the symptoms worsen or if you do not wish to continue, the session will be terminated immediately. Upon further assessment of your condition, you will be advised accordingly, and the study team will help arrange safe transport if needed. The study team will check-in with you by email/phone within 24–48 hours for any further adverse effects.
What are the possible benefits of taking part?
There may be no direct benefit to you personally. However, your participation will help researchers better understand how Visual Snow Syndrome affects vision and perception. This knowledge may support the development of new approaches to managing or treating the condition in the future.
Data handling and confidentiality
Kings College London is the Sponsor of this research and is responsible for looking after your information.
We will need to use information from you for this research project. The research team and authorised administrative staff will use this information to do the research or to check your records to make sure that the research is being done properly.
Your data will be processed in compliance with UK data protection laws, including the UK GDPR and the Data Protection Act 2018.
We will collect information about you which could identify you personally (for example, because the information includes your name or date of birth). We will also collect information about you because we believe it might be relevant to understanding the research. This will include information about your medical history. This information will be stored on computers owned by the hospital and on computers owned by King’s College London. These computers will be securely controlled by the research team, under the direct responsibility of Dr Francesca Puledda, and no-one outside the team will have access to your information.
We will use the information we collect to answer the questions relevant to this research project. In the future it is possible we might have new research questions which could be answered by looking at your information in new ways. We would seek approval from the Research Ethics Committee to use your information for new research projects. If the Research Ethics Committee believed we should contact you again to ask your permission to re-use your information, we will do so. The information we collect in this project will be kept for 3 years and then destroyed securely. Procedures for handling, processing, storage and destruction of your data are compliant with the General Data Protection Regulation 2018.
Further information on how King’s processes research data can be found at:
Please contact the research team if you require further information on data processing or a printed version of the webpage link above.
What if I change my mind about taking part?
You are free withdraw at any point of the project, without having to give a reason. Withdrawing from the project will not affect you in any way. You are able to withdraw your data from the project up until 1 month after the study visit, after which withdrawal of your data will no longer be possible because the data will have been anonymised and combined with other participants’ data, which means it will no longer be possible to remove your individual information. If you choose to withdraw from the project we will not retain the information you have provided.
What will happen to the results of the project?
The results of this project will be used in academic publications and conference presentations and may also form part of future grant applications. Findings may be published in peer-reviewed journals, and anonymised data may be shared with other researchers if appropriate. You will not be identified in any report or publication.
Who should I contact for further information?
If you have any questions or require more information about this project, please contact me using the following contact details:
What if I have further questions, or if something goes wrong?
If this project has harmed you in any way, or if you wish to make a complaint about the conduct of the project you can contact King’s College London using the details below for further advice and information:
Dr Francesca Puledda
Telephone: 020 3299 6387
Email: [email protected]
OR: The Chair, King’s College London, [email protected]
Thank you for reading this information sheet and for considering taking part in this research.