CIRBI IRB# Pro00082846
I. Background and Purpose
Mental health, from drug addiction, to suicide, is a significant societal burden. Unfortunately, the medical field currently lacks any technology to diagnose or track biomarkers of mental health. “Deep tech” innovations, including mobile electroencephalography (EEG) headbands, are emerging for mental health. However, there is currently no neuroscientific solution to harness the data required to resolve biomarkers to aid psychiatric diagnoses or track the health of your brain from home. Citizen science is a new approach that supports the participation of the general public in the scientific process in collaboration with professional scientists (Rosas et al., 2022). In citizen science, software-based innovations, including web and mobile applications, provide the opportunity for citizen scientists to make meaningful contributions to specific areas of interest, from infectious diseases to nutrition (Schaaf et al., 2021). Here, we introduce the concept of “citizen neuroscience,” combining “deep tech” solutions (mobile EEG headbands) with “shallow tech” solutions (mobile applications) to harness brain data on a large scale.
Best practice guidelines for citizen science in mental health research have recently begun to take shape through systematic reviews of the nascent literature (Todowede et al., 2023). The authors of this guidance first identified inconsistencies in the literature prior to suggesting best practices for citizen science projects in mental health, which they recognize as having the potential to transform the mental health system by engaging public involvement at scale. For instance, in their systematic review of 10 citizen science in mental health studies, Todowede et al. found that 2 of the 10 studies obtained ethical approval prior to the commencement of their research, and 3 obtained informed consent from their citizen scientists prior to data collection (Todowede et al., 2023). Safeguards in security across the 10 studies were performed by not collecting personally identifiable information and not recording participants’ IP addresses. Toward greater standardization, the authors developed guidelines based on existing European Citizen Science Association (ECSA) citizen science principles. These guidelines are summarized below.
1. Involvement. Citizen scientists should include individuals with lived experience and minimize barriers to involvement.
2. Genuine science outcome. The work should address knowledge gaps that can transform mental health research and ensure that the research leads to change.
3. Benefits. Benefits for citizen scientists and researchers should be planned from the outset. Benefits to citizen scientists in mental health may include engaging with the research, social connectivity and community, and empowerment.
4. Stages of participation. The contributors/citizen scientists may participate in data collection and analysis, with participation in earlier or later stages also encouraged by researchers.
5. Feedback. Citizen scientists should also benefit from receiving data visualizations of findings.
6. Research approach. Safeguard considerations should be in place for citizen scientists including managing expectations.
7. Public data availability. Open data (publicly available anonymized datasets in an appropriate data repository) is consistent with citizen science principles.
8. Acknowledgement. Presented findings should acknowledge all citizen scientists as an un-named group, or with their permission, significant contributors may be individually named. Approaches should be considered for co-authorship in publications.
9. Evaluation. Beyond evaluation of data quality, the experiences of the citizen scientists and researchers should be evaluated in addition to the wider impact to society or policy.
10. Legal and ethical. If no personal information is collected, the standard approach of not obtaining project-specific informed consent may be appropriate. Technology security, including anonymization should be addressed. A data management plan is recommended, describing how data will be collected, analyzed, reported and shared, and who will own the data and any resulting intellectual property.
The goal of the current study is to take the next step in mental health citizen science by incorporating experimental measures of brain health, thus creating to our knowledge, the world’s first citizen neuroscience study. This citizen neuroscience study uses a mobile electroencephalography (EEG) device (Muse S Gen 2; InteraXon Inc.) to collect brain measures on the citizen neuroscientists, which in turn, is offered back to these contributors as data feedback according to the guidelines listed above. Our central study aim is to support citizen scientists who wish to test whether experimental measures of brain health are affected by neuro-therapeutic interventions that they are planning to receive. Of note, we are not testing the capabilities of the EEG device, but instead are using the known capabilities of the EEG device to test the effects of interventions. Specifically, we are examining three experimental measures of brain health that have been reported in the literature using the Muse device, as well as validated in preliminary laboratory studies by the principal investigator (PI), Dr. Murray. These three EEG measures are detailed in our protocol below.
The PI, Dr. Conor Murray, obtained his PhD in neuroscience in 2019. He is the founder of Psynautics Institute, which is the sponsor to the current citizen neuroscience study, known as Psynautics. Dr. Murray has worked in the field of neuroscience and neuropsychopharmacology for 12 years, with 25 publications in top journals in the field of neuroscience including Neuropsychopharmacology, Biology Psychiatry, Psychopharmacology, and Drug and Alcohol Dependence. Dr. Murray's laboratory experience with EEG and the Muse S device is pertinent to the current protocol, which seeks to determine how experimental measures of brain health are affected by neuro-therapeutic interventions.
II. Introductory Statement
New approaches to enable the collection of “big data” for brain and mental health are needed urgently. Citizen science is a rapidly emerging approach that has recently entered the mental health space to collect mental health data at a large scale. As the field of citizen science has emerged, technological innovations in neuro-engineering have resulted in the development of low cost mobile electroencephalography (EEG) devices. However, no software-based systems have been created to link these devices to the general public to establish the field of citizen neuroscience. This study is designed to support citizen scientists interested in advancing the science of the brain and receiving feedback on brain data (citizen neuroscientists), to fill a major unmet need and contribute to the growth of the brain and mental health ecosystem.
III. General Investigational Plan
This investigational plan outlines a comprehensive study utilizing InteraXon’s Muse S mobile EEG headband and InteraXon’s Muse mobile application in combination with Psynautics’ citizen neuroscience protocol. The Psynautics protocol is an 11-day study, not including optional follow-up assessments, which citizen neuroscientists complete within the Muse mobile application. The investigational plan follows recent guidelines for citizen science in mental health, including providing data feedback to the citizen scientists and dissemination of anonymized data to an open science data repository. The citizen neuroscience study aims to characterize the impact of the intervention on various aspects of participants' well-being, leveraging existing neurophysiological measures and survey instruments. Over the 11-day protocol, the citizen scientists will complete baseline assessments, including demographic surveys, personality evaluations, and emotionality measures, followed by baseline resting state Muse EEG recordings on Days 1 through 5. On Day 6, a neuropsychological treatment session will include both a Muse EEG recording and treatment effects questionnaires to capture immediate responses. Post-treatment assessments will include post-treatment EEG recordings on Days 7 through 11 finishing with a repeat of the same baseline questionnaires on Day 11 to allow for pre vs post assessment. Data feedback will be provided on the same day that the citizen neuroscientist selects the option for the collected data to be analyzed. Optional follow-up analyses on any later dates of interest will provide further insight into the long-term effects of the intervention. The investigation prioritizes structured data collection, rigorous analysis, and personalized feedback to elucidate specific therapeutic effects and optimize future study designs.
IV. Protocol
PARTICIPANTS:
Adult males and females (18+ years of age) in the United States that are planning to receive a neuropsychological treatment will contribute to the study. Participants will be recruited through online postings and/or advertisements, as well as clinics. Participants will provide informed consent prior to participation.
Study inclusion criteria:
All participants must meet the following inclusion criteria to be eligible for the study:
· Male or females aged 18 years or older
· Able to complete procedures and fluent in English
PROCEDURES:
1) Environment: Participants will complete all protocol procedures within the comfort of their own homes with the exception of possible locations of neuropsychological treatment clinics. A minimum of one treatment visit is required for analysis.
2) Timeline: The protocol calls for an 11-day study. The 11 days consist of 5 pre-treatment days, 1 treatment day, and 5 post-treatment days. Day 1 and Day 11 consist of pre-treatment and post-treatment questionnaires, while Day 6, the treatment day, consists of treatment-related questionnaires. Each day also includes a single eyes-closed resting state EEG recording period to examine the pre-treatment, treatment, and post-treatment brain measures. Participants have the option to examine longitudinal effects by using the Muse EEG device at any later date for an additional treatment or post-treatment time point.
3) Clinical-related care procedures outside of the research: On Day 6, participants will receive a neuropsychological treatment or intervention that may be part of clinical care, and will be outside of control or manipulation by the research. Possible treatments that participants may receive as part of clinical care outside of the research include the following, each in the United States:
1. Transcranial magnetic stimulation (TMS), for both FDA-approved and non-FDA-approved (off-label) indications
2. Ketamine assisted psychotherapy (KAP)
3. Psilocybin services (Oregon only)
4. Yoga and meditation therapies
4) Mobile application and mobile EEG device: Participants will complete all procedures through the use of the Muse mobile application, which houses the 11-day Psynautics protocol containing self-report/survey measures. Participants will also complete procedures through the use of the Muse mobile EEG device, which records the EEG measures within the Muse mobile application, which is analyzed according to Psynautics’ EEG measures below for participant feedback and overall data collection.
5) Self-report measures: On Day 1 and Day 11, participants will complete 1) a “Demographics” survey to collect the following information: date of birth, sex, height and weight, highest level of education, general health status, existing health conditions, medications, diet, current exercise, mediation, past 30-day substance use, age at first use and average yearly uses days of alcohol, cannabis, and psychedelics; 2) a “Personality” survey (Big 5 Factor) (DeYoung et al., 2016); 3) an “Emotionality” survey, consisting of the DASS-21, which measures depression, anxiety, and stress (cite) and the World Health Organizations WHO-5 wellbeing measure (Topp et al., 2015); and 4) a “Mentality” survey, consisting of the FFMQ, a trait mindfulness measure. 5) An optional measure related to assessing autism-spectrum traits, is available, the autism spectrum quotient (ASQ) (Baron-Cohen et al., 2001). On Day 6, participants will enter information related to their treatment, including location and name of a clinical site. Prior to treatment, they will complete the Predictor Scale (Carhart-Harris, unpublished). Immediately following their treatment session, they will complete the Drug Effects Questionnaire (Morean et al., 2013), Emotional Breakthrough (Roseman et al., 2019), and Psychological Insight (Davis et al., 2021) and Unpleasant Experience (Carhart-Harris, unpublished) questionnaires. In addition, participants will have the opportunity to provide open-ended text and voice notes during the treatment session on Day 6, or any optional follow-up treatment session following the 11-day protocol.
6) EEG measures
6a) EEG data collection. Every day of the 11-day protocol consists of a single eyes-closed resting state EEG recording obtained with the Muse S Gen 2 mobile EEG. The data will be collected within the Psynautics protocol featured inside of the Muse mobile application, which is exclusively made available to study participants. During the pre-treatment and post-treatment days (Days 1-5; 7-11), participants will record 5 minutes of eyes-closed resting state brain activity. During the treatment day, participants will record up to 30 min of eyes-closed resting state brain activity. On each night of the protocol, participants will also be able to leverage the sleep assessment capabilities of the Muse S device by recording sleep data, which is provided by Muse/InteraXon and separate from the current study.
6b) EEG analysis. The Psynautics protocol analyzes three experimental markers of brain health from the eyes-closed resting state data, based on current literature and preliminary unpublished findings. These markers of brain health are referred to as Cognition, Emotion, and Awareness.
The Psynautics “Cognition” measure is based on work with Muse devices that found age-related change in frontal spectral power that peaks near to the time of peak cognitive performance based on certain cognitive tasks, both about age 40 (Hashemi et al., 2016). Here, we examine frontal spectral power under the anterior-frontal (AF)8 electrode of the Muse S headband. We chose AF8 as our preliminary work in the laboratory identified a role for lifetime cannabis use in blunting the age-related peak in frontal spectral power, which is most prominent in young men (Murray, unpublished findings).
The Psynautics “Emotion” measure is based on work with EEG in patients with depression and anxiety, where asymmetries in alpha spectral power between the frontal left and frontal right cortices are related to the extent of depression or anxiety, although findings are mixed (Kurt Kaiser et al., 2018). In our own hands, in two populations of women, we have validated the use of the Muse EEG headband in detecting relationships to ratings of anxiety on either the Beck Anxiety Inventory or the DASS-21 in relation to alpha power under the AF7 electrode of the Muse headband (Murray, unpublished findings).
The Psynautics “Awareness” measure is based on years of work with EEG in studies examining levels of consciousness from coma and anesthesia to sleep and wakeful states from eyes closed rest to eyes open rest or during increased external stimulation or behavior. Specifically, an EEG measure of the diversity of the signal in the EEG, which is simply a compression algorithm similar to that used to compress files in a .zip folder, is used to quantify this “neural complexity” which is considered a neural correlate of consciousness. We use open source algorithms, Lempel-Ziv Complexity and Permutation Entropy (Liu et al., 2023), to measure Awareness across all four sensors of the Muse S headband.
7) Feedback. Following the 11-day protocol, or at the time the citizen neuroscientist is interested in receiving feedback, they will be able to select the feedback option with the Psynautics protocol of the Muse app. Within an hour, a detailed analysis of each of the measures listed above will be provided to the participant from Muse/InteraXon via email.
V. Protection of Human Subjects
1. SOURCES OF RESEARCH MATERIAL:
Participants will be informed that data will be obtained specifically for either their own feedback or for research purposes. We will use, as data, all self-report information, observer records, and physiological, and behavioral information collected during test sessions. Data will be coded with numbers assigned to each participant. Electronic transmission of information regarding a participant will only use an assigned number to identify the participant. Additionally, computers with participant-related information are password protected, and only the PI has access to the passwords.
2. POTENTIAL RISKS & ADEQUACY OF PROTECTIONS AGAINST RISK:
EEG device: There are no known risks of EEG or to the mobile EEG device.
Neuropsychological treatments: The major potential risks are related to novel neuropsychological interventions that the participants may be interested in testing as part of clinical care outside the research. Neither Psynautics Institute nor InterAxon/Muse provide any recommendations to individuals or suggest any novel treatments or clinics. Thus, the citizen scientists are investigating these treatments at their own risk or benefit to the mental and brain health.
Confidentiality: Potential participants divulge information that is sensitive and may have adverse social consequences if released. This would include information released to insurance companies, health care agencies, family members, or made public in any way. Specifically, all data records containing identifying information, such as emails, will be kept on password-protected computers. Only the principal investigator will have access to identifiable information, which will be maintained on site under lock and key. As an additional safeguarded against these risks, only InteraXon/Muse will have a key that links personally identifiable information to the data collected within the study, as is routine for their company in collecting brain data and in delivering Muse headbands to named individuals at their place of residence. Psynautics serves as the intermediary and software-system between participants and InteraXon/Muse to support the citizen neuroscience effort, which may include corresponding with participants from recruitment through completion. Psynautics Institute will not sell any data to any third party. All anonymized/de-identified data will be shared from InteraXon/Muse with Psynautics so that Psynautics can upload these data to Open Science Foundation, an open data repository.
Participant Education & Consent Procedures:
· All participants will be informed of the possible risks previously mentioned through the informed consent. Participants will provide informed consent via the Psynautics protocol within the Muse mobile application prior to commencing study procedures.
3. POTENTIAL BENEFITS OF THE PROPOSED STUDY
Citizen science is made possible by citizen scientists who stand to benefit from their participation. For the current citizen neuroscience study, the participants benefit primarily in the opportunity to make innovative contributions to the fields of neuroscience and psychiatry. Second, participants have the opportunity to receive interesting feedback related to the experimental markers of brain health in the form of personalized data reports that are emailed to them at the end of the participation. In addition, we anticipate that organizations, such as clinics, will be interested in having their new patients sign up for our study to gain data insights on their clinical practice.
4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED
There is an urgent unmet need for large-scale data on the mind and brain to drive new objective, diagnostic measures for neuropsychiatry, and to facilitate personalized medicine across individuals from diverse demographic backgrounds. The knowledge that stands to be gained from citizen neuroscience, starting with the current proposal, is as immense as the dataset that stands to be collected. We expect that these data will directly contribute to the identification of more precise biomarkers that can assist medical professionals in both the diagnosis and prognosis of mental health in relation to existing and emerging neuropsychological therapeutics.
VI. Instruments used:
Pre-treatment assessments:
1. Demographics survey: 5 min
2. Personality survey (Big 5 Factor Inventory): 5 min
3. Emotionality survey (DASS-21; WHO-5): 3 min
4. Mentality survey (FFMQ): 5 min
5. Eyes-closed resting state EEG (Muse S Gen 2 headband): 5 min
Treatment assessments:
1. Treatment information survey: 1 min
2. Predictor Scale: 2 min
3. Drug Effects Questionnaire (DEQ): 1 min
4. Emotional Breakthrough: 1 min
5. Psychological Insight: 3 min
6. Unpleasant Experience: 1 min
7. Eyes-closed resting state EEG: ~30 min
Post-treatment assessments:
1. Demographics survey: 5 min
2. Personality survey (Big 5 Factor Inventory): 5 min
3. Emotionality survey (DASS-21; WHO-5): 3 min
4. Mentality survey (FFMQ): 5 min
5. Eyes-closed resting state EEG: 5 min
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