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Study Description

NeurOptimal® Dynamical Neurofeedback is a brain training technology that is offered in many countries across the globe. 
NeurOptimal® Training helps a brain to optimize its own function. An individual typically experiences benefits in several areas of his or her functioning. People seek Training for many different reasons and regardless of their specific goals they often also receive outcomes beyond those initial desires and hopes. 

Purpose of the study
To gather data about why people seek sessions, their training experience, and what is gained. In addition, to collect these data in and throughout our international community of NeurOptimal® providers so as to reach a broad population of end users.

These questionnaires are originally in English and translated into the following languages: French, Italian, Spanish, and Dutch. 

Providers of NeurOptimal® Training across the world will help collect data by inviting their clients to participate in this study. Clients will fill out an online survey that consists of two parts. The first questionnaire needs to be filled out before beginning Training. After the client decides to end their series of sessions he/she will fill out the second part of the survey.   

The survey is funded by Breingoed and West Seattle Neurofeedback but conducted through the website of a third party named Triqs which will also analyze the data. Triqs is a Dutch data analysis bureau. The study will have a duration of 12 months.

Providers will sign up for participation and sign a contract with bureau Triqs. They will receive and then administer codes to their clients which will give them access to the questionnaires. These questionnaires are being offered in 5 different languages: English, French, Italian, Spanish, and Dutch.

The prospective client fills out the first questionnaire before the first NeurOptimal® session. In order to do this, the client receives a code from the provider and is sent to the website of Triqs where the code gives access to the first questionnaire.

The NeurOptimal® Training itself is no different than outside this study and will be outlined in the next paragraph. After the client decides to end the series of sessions he or she receives the code for the second questionnaire and fills it out online. After completion, the client gets access to his/her own data and will also receive a graphic representation of part of their responses.
NeurOptimal® Training is done according to the standard procedure: 5 EEG sensors are being attached to ears and scalp, with 2 flat sensors placed on the scalp at positions C4 and C3 near the top of the head, 1 clamp style sensor to the top of the left ear and 1 clamp style sensor to the top of the right ear with 1 clamp style sensor attached to the right earlobe. Conductive paste is applied on the sensors to attach the sensors to the skin and to conduct the electrical signal that is being measured from the scalp. 

The client then typically listens to music while relaxing (other media options are possible as well as engaging in activities like reading or coloring while listening to the music). The software reads the cortical activity and provides the brain with brief interrupts when it detects sudden or abrupt shifts in the EEG. These interrupts help the brain to pull away from what it’s doing and orient to the present. In this process of Training the brain re-organizes itself over and over again and starts to function more effectively and efficiently (again).
Benefits and Risks of Participation 
The benefits and risks of participating in this study are no different from 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 session, and therefore, it is not possible to predict the outcome of participating in this study.  

Real or Perceived Conflicts of Interest
It is possible that a perceived conflict of interest may exist within this study, as the study leaders are also owners and operators of NeurOptimal®-based businesses. One of the study leaders is a representative of NeurOptimal® Neurofeedback who sells and promotes Zengar®’s products and services.   

Trainer Requirements
To participate in this study as a provider/Trainer, a provider must first sign a contract with Triqs, the analyzing bureau. 

The reason Triqs wants you to sign this contract is that they process data arising from the relationship between a client and the practice owner. This data is tied to this particular study and therefore a signed contract is required. The contract is not specifically about the data delivery (the “accumulated and anonymous client report” you may or may not request) but about the data processing itself. Working with an ISO-certified research bureau naturally leads down this path.

At no point during or after the study will the provider, nor any other party, receive individual client data.

Study Participants Requirements
To take the survey the client must meet one of the following criteria: he/she is new to NeurOptimal® and is starting with their first series of sessions, or he/she has done Training with NeurOptimal® in the past and is returning for a new series of Sessions. We are excluding those clients who are currently training with a provider/Trainer for some time now (as we want the client to assess their ‘baseline’ when they seek Training). 

Participation in this study is voluntary and will not affect the client’s relationship with their NeurOptimal® Trainer.  Participants are free to withdraw or discontinue participation in this study at any time without prejudice. 

For the client: no other than the costs a client would have made anyway for the Training. They’re paying session fees, as outlined by their NeurOptimal® Trainer. 

For the practice owner/trainer: the costs for the optional report are €95  (euro) (excluding taxes, if applicable).  

Participants will not be compensated for participating in this study. At the end of the second questionnaire, they will receive their individual answers they gave in the survey as well as receive a graphic representation of some of their responses. 

Sharing Results 
After all data has been analyzed, results will be shared within the Neurofeedback community and other stakeholders who have expressed, and who will express interest in the future. 

Data Collection, Confidentiality, and Security of Data
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 will be assigned codes and not be linked to names, birth dates, or any other identifiable information. You will be asked not to mention any names, persons, or companies in your answers. Should you forget this Triqs will ‘clean up’ before publishing, the bureau has guaranteed anonymity.
For the duration of the study, all information received from participants will be stored online in one location and managed by Triqs, the Dutch analyzing bureau. Only authorized members of the research team and authorized third-party analysts will have access to the files and data obtained in this study.

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