INFORMED CONSENT FOR PARTICIPATION IN RESEARCH

Sponsor / Study Title:

Psynautics Institute / “Citizen neuroscience study of experimental markers of brain health before and after treatments”

Protocol Number:

Pro00082846

Principal Investigator:

Conor Murray     

Telephone:

317-437-4992 (24 Hours)

Address:

Psynautics Institute

1934 Westridge Rd.

LOS ANGELES, CA    90049 

KEY INFORMATION: The following is a short summary of this study to help you decide whether or not to be a part of this study. More detailed information is listed later on in this form.

Why am I being invited to take part in a research study?

You are invited into this research study because you are someone who is planning to receive a neuropsychological treatment and wish to examine whether this treatment might affect experimental markers of brain health.

What should I know about a research study?

·       Someone will be available to explain this research study to you.

·       Whether or not you take part is up to you.

·       You can choose not to take part.

·       You can agree to take part and later change your mind.

·       Your decision will not be held against you.

·       You can ask all the questions you want before you decide.

Why is this research being done?

This study seeks to understand the impact of interventions on various aspects of mental and brain health. This investigation is driven by the need to advance our understanding of therapeutic interventions and optimize treatment protocols for individuals seeking to enhance their psychological well-being. Ultimately, the research endeavors to contribute valuable insights that can inform the development of effective interventions and improve the quality of care for individuals experiencing mental health challenges. Here, treatments will be used in a clinical or standard of care setting and not for treatment indicated for research purposes only.

How long will the research last and what will I need to do?

The research will last 11 days with option of follow-up assessments to examine long-term effects. On the first and last day, you will need to answer questions related to demographics, personality, emotionality, and mentality. On each day, you will wear a headband for 5 minutes with your eyes closed to record brain activity at rest. However, on your planned treatment day, Day 6, you will record for up to 30 minutes instead of 5, and you will also answer questions related to the type of treatment and the effects of the treatment. More detailed information about the study procedures can be found under “What will happen if I take part in this study?”

Is there any way being in this study could be bad for me?

There are no known risks of the device that will be used to record your brain activity (Muse S Gen 2); it is not a stimulation device. Any risks related to your neuropsychological intervention will need to be discussed with your clinicians. More detailed information about the risks of this study can be found under “What kind of risks or discomfort could I expect?”

Will being in this study help me in any way?

Yes, as a “citizen neuroscientist” in this study, you will receive feedback/access to your brain data while contributing to your area of interest.

What happens if I do not want to be in this research?

Participation in research is completely voluntary. You can decide to participate or not to participate. Your alternative to participating in this research study is to not participate.

Introduction

The study investigator and associates from Psynautics are conducting a research study.

About 1,000 participants will be in this study.

The investigative team will be available to explain the study to you. Research studies are voluntary and include only people who choose to take part. Please take your time about deciding whether to participate in this study. Before deciding:

·       You can discuss this study with friends and family.

·       You can also discuss it with your health care doctor or research a second opinion.

·       If you have questions, you can ask researchers for more information before deciding to participate.

Why is this study being done?

This research aims to investigate the efficacy neuropsychological treatments on experimental measures of brain health using the Muse S Gen 2 headband and Muse mobile application, which houses the Psynautics study and analyses relevant to this study. The study seeks to understand the impact of various interventions on aspects of brain and mental health. This investigation is driven by the need to advance our understanding of therapeutic interventions and optimize treatment protocols for individuals seeking to enhance their psychological well-being. Ultimately, the research endeavors to contribute valuable insights that can inform the development of effective interventions and improve the quality of care for individuals experiencing mental health challenges.

Participation is Voluntary

Participation in this study is voluntary. A decision to not participate or withdraw your participation will not affect your current or future treatment. You will be informed of any new findings or risks that arise that may affect your willingness to continue in this study.

The investigator may also decide that your participation should be discontinued, without your consent, if they think that this is better for you.

What will happen if I take part in this study?

If you take part in this study, you are someone who is planning to receive a neuropsychological treatment and wish to know whether this treatment affects your brain by recording brain activity with a comfortable headband in the days before and after this treatment, as well as during the treatment itself. Therefore, if you take part in this study, you are already planning to take part in a neuropsychological treatment session, and you will have already purchased a Muse S Gen 2 headband to contribute to the research with the optional benefits of tracking sleep, meditation, and brain health beyond the study period.

Once you have scheduled your neuropsychological treatment and received your new Muse S headband from the company InteraXon, and have downloaded the Muse app to access the Psynautics study, you are expected to work through the Psynautics study as it appears in the Muse app as a list of modules that are to be completed over an 11‑day span.

The first module within the app will provide instructions on how to obtain a clean signal with the headband. Thereafter, the study will call for completing pre-treatment, treatment, and post-treatment surveys, which will each take 5 to 10 minutes total to complete. Specifically, the pre-treatment surveys include a “Baseline Survey” that will record your demographic information, including current health and medication status, diet, and substance use in the last 30 days. The pre-treatment surveys also include “Personality,” “Emotionality,” and “Mentality” surveys, which will assess your personality, mood states, and the impression of your cognitive ability. An optional survey is related to assessing the health of individuals on the autism spectrum. Each of these surveys will be completed again at the post-treatment period. On the treatment day, additional information will be obtained related to your treatment of choice and the clinical environment, as well as acute subjective effects related to the treatment.

In addition to surveys, the only other requirement for the study is to measure brain activity for 5 minutes daily over an 11-day span, always with eyes closed in what is known as a resting state, comfortably seated without movement. Specifically, on Days 1 – 5 and 7 – 11, brain activity will be recorded in this manner for 5 minutes, ideally at the same time of day on each day. On Day 6, the treatment day, the brain recording will take place in a similar way except the resting state will occur simultaneously with the treatment itself, over about 30 minutes during the treatment.

Once you have completed your data entry over the 11-day span and are ready to examine your results, you will simply select the button to allow for your data to be analyzed within the app and you will promptly receive a detailed personalized report emailed to you from Muse/InteraXon.  The headband is yours to keep, and your anonymized data will become open data shared with researchers across the globe for future analyses and publications beyond the current study.

What kind of risks or discomfort could I expect?

There are no known risks to either completing the various surveys over your mobile device or the use of the mobile EEG headband device. However, the surveys themselves may be upsetting; you do not need to answer any question that you are not comfortable with.

The EEG headband is comfortable, so comfortable that it is marketed for sleep (the “S” in “Muse S” stands for sleep).  Therefore, you will also have the option of obtaining sleep data during and after the study. The sleep data you collect during the study will be included in your study report. There are also no known risks of EEG brain recordings. Please note that the EEG device is merely a recording device, like a microphone, and is not a stimulation device.

There may be risks associated with the neuropsychological treatment that you are planning to receive, including both non-pharmacological and pharmacological neuromodulation approaches. These risks should be discussed with your primary care physician and the clinician who is overseeing your treatment, so that you are fully informed of the risks and benefits of the treatment that you are seeking.

A final risk is related to confidentiality of the information that you provide. The investigative team, including Murray Sciences, LLC and Psynautics, will not sell any data to third parties. Murray Sciences, LLC and Psynautics also only receive anonymized data from InteraXon/Muse, which is then shared to an open data repository, Open Science Foundation, therefore preventing possible breaches of confidentiality.

Are there any benefits if I participate?

There are no known benefits to you from your taking part in this research. We cannot promise any benefits to others from your taking part in this research. However, possible benefits to others include helping scientists learn more about effects of emerging treatments and potential roles in helping with mental health. The information collected as part of this study is being obtained for research purposes only.

The data are not being collected for clinical purposes and will not be provided to you unless there are clinically relevant findings that may be reviewed by a study investigator or provided to you to take to your primary care physician. However, you will receive the data that you provided from the EEG device and in surveys in a PDF aggregate, which will be automatically emailed to you upon completion of the Psynautics study.

What other choices do I have if I don’t want to participate?

The alternative is to not participate in the study.

How will information about me and my participation be kept confidential?

The researchers have designed this study to ensure that your private information is kept confidential. Information about you will be handled as confidentially as possible, but participating in research includes inherent risks of a loss of privacy and the potential for a breach in confidentiality. Study data will be physically and electronically secured. As with any use of electronic means to store data, there is a risk of breach of data security. While every effort will be made to protect the privacy of your information, absolute confidentiality cannot be guaranteed.

Copies of consent forms will be kept in a locked file, and your name will never be used in publications or presentations. Your name and other identifying information will be stored in an electronically secure database associated with InteraXon/Muse.  All of the computers that contain participant-related information are encrypted and password-protected and only the investigative team have access to the passwords. Once you are enrolled into the study, only your assigned number will be used to identify you on all documents, including electronic documents.

Publications and/or presentations that result from this study will not identify you by name. Once identifiable information has been removed from the study data, it will become available to other researchers and used for future studies without your additional informed consent.

Are there any costs for taking part in this study?

This study is entirely funded by citizen science participation. You will therefore pay for the cost of a new Gen 2 Muse S headband and data analytics, which Psynautics has secured for a discounted rate for the study, for a total of $280 plus tax.

Will I be paid for my participation?

You will not be paid for your participation.

The headband is yours to keep for additional benefits of tracking sleep, meditation, and markers of brain health over time.

What other things should I consider before participation?

Use of my information:

The information collected as part of this study is being obtained for research purposes only. The data are not being collected for diagnostic purposes; however, your participation will contribute to a database that is designed to inform future diagnostic capabilities of similar brain devices.

Whom to contact about this study

During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:

• Whom to contact in the case of a research-related injury or illness;

• Payment or compensation for being in the study, if any;

• Your responsibilities as a research participant;

• Eligibility to participate in the study;

• The investigator’s or study site’s decision to withdraw you from participation;

• Results of tests and/or procedures;

Please contact the investigator at the telephone number listed on the first page of this consent document.

If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.

An institutional review board (IRB) is an independent committee established to help protect the rights of research participant. If you have any questions about your rights as a research participant, contact:

• By mail:

Study Subject Adviser

Advarra IRB

6100 Merriweather Dr., Suite 600

Columbia, MD 21044

• or call toll free:    877-992-4724

• or by email:          adviser@advarra.com

Please reference the following number when contacting the Study Subject Adviser: Pro00082846.

The Psynautics investigators will answer, to the best of their ability, any questions you may have now or in the future regarding study procedures or your response to them.  If you have any questions, you can email Jyoti Gill, the Psynautics director of operations, at jyoti@psynautics.com.

What are my rights if I take part in this study?

Taking part in this study is your choice. You can choose whether or not you want to participate. Whatever decision you make, there will be no penalty to you and you will not lose any of your regular benefits.

·       You have a right to have all of your questions answered before deciding whether to take part.

·       If you decide to take part, you can stop being in the study at any time.

·       You do not give up any of your legal rights by agreeing to be in this study.

·       You have a right to a copy of this informed consent form.

How do I indicate my agreement to participate?

If you agree to participate in this study, you should check the box [within the Muse app, Psynautics Study]

I have read this information, which is in English.  This is the language that I read and understand.

By checking “I Agree”, you confirm your understanding of the terms and conditions, and consent to participate in this study under the terms outlined above.

   I Agree — I have read the terms and disclaimer and agree to participate in this study.