What you need to know before you agree to participate…
NeurOptimal® and Post-Acute COVID-19 Study
In what ways does NeurOptimal® improve the general well-being of participants who have had COVID-19?
Individuals considered to be recovered from COVID-19 are experiencing a wide variety of persistent concerns after they are considered negative for the virus, now named Post-Acute COVID-19. It is now understood that these concerns are being reported for many months following infection and “recovery”, adversely affecting individual quality of life. Those suffering from Post-Acute COVID-19 indicate that concerns (loss of sense of taste and smell, anxiety, difficulty sleeping, and cognitive dysfunctions, including brain fog, difficulty concentrating or focusing, and memory problems) are interfering with the ability to return to work and school, to manage a household, as well as enjoy other life activities.
Purpose of the Study
The purpose of this study is to gain insight into the ways in which NeurOptimal® might improve the general well-being of participants who have had COVID-19. Kelly Jamieson with North Delta Neurofeedback and Kelly Kalkwarf with West Seattle Neurofeedback, along with an international group of NeurOptimal® trainers, are conducting a study on the impact of NeurOptimal® Dynamical® neurofeedback regarding Post-Acute COVID-19 concerns and quality of life. These trainers are passionate about what they do and have a desire to understand how NeurOptimal® neurofeedback training might help individuals who are suffering from Post-Acute COVID-19 concerns.
Summary of the Study
This study will run for 24 months and will accept participants on a rolling basis until November 19, 2022. All qualified participants will complete neurofeedback sessions and report the severity of their Post-Acute COVID-19 concerns using a preselected list over a maximum duration of six consecutive months. The group will report changes to their concerns after completing a 33-minute NeurOptimal® neurofeedback session. For the neurofeedback participant to complete the study, a minimum 20 total sessions of neurofeedback with NeurOptimal® within six months.
Data will be collected for 24 months and will then be analyzed by a third-party.
Prospective participants will be directed to complete a Participant Intake Questionnaire accessible via a link on the study’s website, which will request contact information and personal health and wellness information, and in which group they intend to participate. After their intake form is received, the participant will be assigned a unique number based on their date of birth. This participant identifier number will be used for all subsequent participation and communication in the study, data collection, and presentation.
The Trainer or participants (if renting a NeurOptimal® system for home-use) will follow normal NeurOptimal® procedures. They will use conductive paste to attach 5 EEG sensors to the head and ears: 2 flat sensors will be placed on the scalp at positions C4 and C3 near the top of the head, 1 clamp style sensor will be attached to the top of the left ear and 1 clamp style sensor will be attached to the top of the right ear with 1 clamp style sensor attached to the right earlobe. Conductive paste will be used between the sensor and the skin and will touch the skin. When the neurofeedback session starts, the participant will listen to the default music via earbuds, headphones, or through speakers for a default session lasting 33 minutes. When the session is over, the Trainer (or participant) will remove the sensors and paste. At the end of each session, he or she will be asked to go to the website portal to fill out a Post-Session Survey Report. Individuals participating in this group may complete the NeurOptimal® sessions at their own pace, as long as they are completed within six months after they begin.
Benefits and Risks of Participation
The benefits and risks of participating in this study are no different than the benefits and risks of using NeurOptimal® outside of this study. Participants may experience an increase in quality of life after participating in this study. Participants are reminded to always consult their physicians before starting any training program. It is not possible to predict how a person’s central nervous system will respond to the information it receives during a neurofeedback system, and therefore, it is not possible to predict the outcome of participating in this study.
For the duration of the study, all information received from participants will be stored online in one location and managed by the study leads. This data will be accessible only by authorized members of the study team.
Data collection will begin April 15, 2021, and will end April 15, 2023. Data will be received through post-session surveys submitted by each participant after each neurofeedback session (or weekly for the non-neurofeedback group) via links on the website portal. Participants will indicate neurofeedback session number or week number, and report changes to their Post-Acute COVID-19 concerns, as well as answer general quality-of-life questions.
Once data collection is complete, all data will be downloaded into a password-protected spreadsheet and analyzed by a third-party.
Confidentiality, Security of Data, and Retention Period
All participants will be assigned a unique identification number to protect their privacy during this study. The data and records received in this study will be kept confidential on password-protected electronic devices. No individual identities will be used in any reports or publications resulting from the study. All questionnaires and post-session surveys (and any photos and videos) will be assigned codes and stored separately from names or other direct identification of participants.
Only authorized members of the research team and the authorized third-party analysts will have access to the files and data obtained in this study, and only those with an essential need to see names or other identifying information will have access to that file. (i.e. concerns about a participant’s wellbeing or safety).
All data will be stored on Google Drive, housed in the United States, in compliance with US data laws and policies. After the study is complete, all data will be kept for 2 years and then destroyed. All data will be confidential, and participants will be referred to by their unique participant number in all communications, study documentation, reports and presentations.
Real or Perceived Conflicts of Interest
It is possible that a perceived conflict of interest may exist within this study, as trainers conducting this research are also owners and operators of NeurOptimal®-based businesses, seeking to understand and share the benefits of NeurOptimal® with those suffering from lingering COVID-19 concerns.
Access to the forms listed below will be via a website portal. To participate in this study, individuals must have access to the internet and use a computer or their mobile device to interact with the forms.
- Participant Intake Questionnaire
- Trainer Participation Intake Form
- Post-Session Survey Report
- Study Exit Questionnaire
To participate in this study as a Trainer, providers must complete the Trainer Participation Intake form. They will then be listed on the study website as an approved Trainer for the duration of the study.
Trainers will use their existing flow of clientele to populate this study. There will be a one-page brochure to advertise this study to attract and inform new study participants. Those who do not have a trainer will be matched with one closest to them or offered a rental system if one is available. Any raw data collected will not be distributed to Trainers. Trainers may assist their participants with submitting the Post Session Survey by providing a tablet, computer or other internet enabled device. It is not our intention to use or accept printed versions of the post session survey, however, if a trainer has the desire to use this method, they may do so by entering the client’s data themselves using their own resources. Participating trainers will follow confidentiality and ethics practices to ensure proper handling of client information and ethical treatment of all participants. It is not a requirement of the trainer to complete the Post-Session Survey Report for his or her clients.
Study Participants Requirements
All participants will need to have had a confirmed case of COVID-19 and have Post-Acute COVID-19 concerns. There are no age limits for participants. All participants must have made arrangements to pay their Trainers fees for NeurOptimal® sessions. They will also need regular access to the internet to navigate the study website, which will contain the Participant Intake Questionnaire and Post-Session Survey report forms. Participants will need to be able schedule sessions and travel at their own expense to and from a Trainer’s office to complete 20 NeurOptimal® sessions within a timeframe of six consecutive months.
Participation in this study is voluntary and will not affect client’s relationship with their NeurOptimal® Trainer. Participants are free to withdraw or discontinue participation in this study at any time without prejudice.
Procedure for Withdrawing From the Study
To withdraw from this study, participants need to provide a written withdrawal statement. Please email info@postCOVIDstudy.com with your participant number and a brief message. All participants will have the option to request that their incomplete data be withdrawn completely from the study.
To participate in this study, participants will be responsible to pay session fees, as outlined by their NeurOptimal® Trainer.
Participants will not be compensated for participating in this study.
After all data has been analyzed, results will be shared within the Neurofeedback community, and with any other stakeholders who have expressed interest in understanding how NeurOptimal® might benefit those who have had COVID-19.
An email address specific to this study will be set up for participants to ask questions. All communication to participants will be from this email address. Expected communication will be after an individual fills out the Intake Questionnaire occasional reminders to fill out their Post Session Survey.
We recognize that due to the lack of funding and resources this study excludes a large segment of the global population who have had COVID-19 who will not be able to participate due to internet access, geographic location, or financial means. This creates an inequitable study that may overlook groups of people who have been more affected by COVID-19 than others. It is our hope that this study will spark a larger academic study to look at the impacts of NeurOptimal® training as an integrative service to help individuals suffering from Post-Acute COVID-19.
These are secured and paid for but not live until April 10, 2021
Kelly Kalkwarf – email@example.com
Kelly Jamieson – firstname.lastname@example.org