A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing- A Wearable Wellness Brain Sensing Device (Muse-S) in Newly Diagnosed Fibromyalgia Patients.
Phase: NA
Conditions: Fibromyalgia
Sponsor: Mayo Clinic

Muse and Fibromyalgia 
PI: S. Nanda, MD  
Mayo Clinic – NCT04720053 
 
 
 
 
 
 
 
 
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A Feasibility Study Evaluating 
Mindfulness-Based 
Intervention Assessing A 
Wearable Wellness Brain 
Sensing Device (Muse-S) in 
Fibromyalgia Patients. 
 
Study Protocol 
 
NCT04720053 
 
06/24/2024 
 
 

Muse and Fibromyalgia 
PI: S. Nanda, MD  
Mayo Clinic – NCT04720053 
 
 
 
 
 
 
 
 
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General Study Information 
 
Principal Investigator:  Sanjeev Nanda, MD; 
 
Co-principal investigators:  Ivana Croghan, PhD; Ravi Ganesh, MD 
 
Study Title:  A Feasibility study evaluating Mindfulness-Based Intervention Assessing A Wearable 
Wellness Brain Sensing Device (Muse-S) in Fibromyalgia Patients. 
 
Protocol date of most recent review and approval:   24 June 2024 
 
Research Question and Aims 
 
Hypothesis:  Patients with fibromyalgia often deal with continual stress, sleep issues, and pain symptoms.  
We postulate that using the novel muse headband can provide mindfulness training to benefit the quality 
of life and sleep, and decrease stress and pain. 
 
Aims, purpose, or objectives: 
1. To study the feasibility of a wearable brain sensing wellness device to provide mindfulness 
training to fibromyalgia patients. 
2. To assess the association between duration of active state and calm state as measured by the Muse-
S Headband System, and quality of life (QOL), subjective stress, sleep, and pain in fibromyalgia 
patients. 
 
The primary outcome will be the change in wide pain index (WPI) and stress over time. 
 
Background:  
Up to 8% of the population has fibromyalgia. These patients often have stress1, poor coping and 
adaptation skills2.  Many of these patients also have multiple constitutional symptoms including  irritable 
bowel syndrome3, chronic headaches4, depression and anxiety5,6,7. 
Mind body therapies have become a popular treatment option with practitioners and patients8. Integrative 
medicine interventions including, yoga, Tai Chi, hypnosis, acupuncture, meditation, and other modalities 
have shown to improve physical and emotional well-being9.   Muse-S is a clinical grade, headband-style 
wireless EEG system designed to interact with a mobile device (a smartphone or tablet). In combination 
with the Muse-S app running on iOS or Android smartphones, Muse-S converts EEG signals 
measured over the frontal and temporal cerebral cortices into measures of brain state. Calibrated to an 
individual user, Muse-S distinguishes between active and calm brain states to provide real-time 
performance feedback, and helps users realize the benefits of mindfulness practice in an engaging and 
accessible manner.  This has been tested in a prior study with patients undergoing breast cancer surgery10. 
 
Study Design and Methods 
 
Methods:   
All study participants will receive the Muse S™ Headband system and will be asked to use the program 
daily.   

Muse and Fibromyalgia 
PI: S. Nanda, MD  
Mayo Clinic – NCT04720053 
 
 
 
 
 
 
 
 
Page 3 of 8 
 
 
We will assess the following:  
• Changes in QOL, sleep, stress, and WPI 
• These changes will be measured through week 2, month 1, month 3 and month 6.   
 
 
Consent 
/screen 
/baseline 
Treatment Phase 
Follow up 
Phase 
 
1 
2 
3 
4 
5 
Visit Type 
Face to 
Face 
Phone/ 
email 
Phone/ 
email 
Face to 
Face/phone/
email 
Face to 
face/phone/
email 
Visit Days 
0 
14 
30 
90 
180 
Informed Consent 
X 
 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
 
Demographic and History Form 
X 
 
 
 
 
Numeric Pain Intensity Scale 
(NPIS) 
X 
X 
X 
X 
X 
Center for Epidemiology Studies 
Depression (CES-D) 
X 
 
 
X 
X 
Widespread Pain Index (WPI) 
X 
 
 
X 
X 
Linear Analogue Self-Assessment 
(LASA -  QoL) 
X 
X 
X 
X 
X 
Stress Scale (PSS) 
X 
X 
X 
X 
X 
Pittsburgh Sleep Quality index (PSQI) 
X 
X 
X 
X 
X 
Satisfaction Survey (WIWI) 
 
 
 
 
X 
Adverse Events 1 
 
X 
X 
X 
X 
Concomitant Medication 2 
X 
X 
X 
X 
X 
Instructions for Muse-S  
X 
 
 
 
 
End of Treatment/End of Study Forms 
 
 
 
X 
X 
1 = For visit 5, only serious adverse events will be newly collected; 2 = For visit 5, only newly added concomitant medications 
for fibromyalgia symptoms will be collected  
 
Study Visit Windows: 
Each visit will have a window from midpoint of prior visit to midpoint of latter visit.   
 
Data Collection: 
Subjects will have the options of completing study surveys/questionnaires online via email link to 
REDCap prior to study visit.  If not completed by time study visit takes place, the coordinator can provide 
the Ipad digital version of the survey/questionnaire to the subject for the in-person visits or can interview 
the patient via phone for the telephone visits.   
 
Data Collection in this study will utilize REDCap.11  All other data collection will be entered directly into 
this password protected system.   
 
Assessments: 
Safety: 

Muse and Fibromyalgia 
PI: S. Nanda, MD  
Mayo Clinic – NCT04720053 
 
 
 
 
 
 
 
 
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• CES-D (Center for Epidemiological Studies – depressed Mood Scale): A validated and frequently 
used self-report measure of depressive symptoms.12 
 
Outcomes:  
• Demographics Form:  This form collected demographic and other lifestyle history of the research 
subject. 
• Linear Analogue Self-Assessment (LASA)13-15:  A six-item measure of quality of life (QOL), in which 
QOL is conceptualized as a multidimensional construct with five domains (physical, functional, 
emotional, spiritual, and social).  This data will be collected at screen (prior to any treatment), day 14, 
day 30, day 60, end of treatment day 90, and at end of study day 180 (6 months post last treatment).   
• Stress:  Will be evaluated through the Perceived Stress Scale (PSS)16,17. The PSS is a 10-item Likert 
scale that measures global life stress by assessing the degree to which experiences are appraised as 
uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater 
perceived stress. Reliability is reported as 0.85, with Cronbach alphas ranging from 0.75-0.86.  
• Widespread Pain Index (WPI)18:  defined as a 4-quadrant plus axial pain, measuring widespread pain 
in 19 specific places on both sides of the body, above and below the waist This data will be collected 
at screening, end of treatment day 90, and at the end of study day 180 (6 months post last treatment). 
• Numeric Pain Intensity Scale (NPIS):  0-10 pain assessment scale.  Participants rate their pain on a 
scale of 0 to 10. Zero means “no pain,” and 10 means “the worst possible pain”. 
• Sleep Quality: The Pittsburgh Sleep Quality Index (PSQI)27-29 is an effective instrument used to 
measure the quality and patterns of sleep in adults. This is a 9-item, likert scale, validated, scoring 
system.  It differentiates “poor” from “good” sleep quality by measuring seven areas (components): 
subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, 
use of sleeping medications, and daytime dysfunction over the last month. 
• Satisfaction with the program: Was it Worth it Questionnaire (WIWI)19 This satisfaction survey will be 
administered to the participants after completing intervention and at the end of the study, probing their 
satisfaction with the research study. These data could be used to assess the feasibility of the intervention 
by asking the patient if the entire research experience was worth it for them. 
 
Adherence to Intervention: 
• 
Adherence to the Muse-S will be assessed by de-identified data available within the cloud, 
provided by InteraXon.  InteraXon only has information per subject through subject ID only 
(as was provided by Mayo Clinic site), so when the cloud data is provided to Mayo, it will be 
linked to each subject through their study ID.   
 
Intervention:  
• The Muse-S Headband system: 
   The Muse-S Headband system is a brain sensing headband that measures brain activity by detecting 
electrical impulses created by the brain.  The Muse-S Headband system uses a series of focus 
attention training methods to train the brain.  Each focus attention session takes approximately a 
minimum of 5 minutes, and has been shown to reduce stress, anxiety, and improve focus and 
productivity.  The Muse-S Headband system has seven sensors with four channels of EEG data for 
an accurate, high-quality experience.  The battery life is approximately five hours and uses an 
industry-standard micro-USB charger. Forty Muse-S Headband systems will be provided by the 
manufacturer at no cost in support of this study.  
 

Muse and Fibromyalgia 
PI: S. Nanda, MD  
Mayo Clinic – NCT04720053 
 
 
 
 
 
 
 
 
Page 5 of 8 
 
Use of Muse-S Headband systems will be demonstrated to each participant prior to their first 
mindfulness practice session, which will be completed during the baseline visit with the study 
coordinator.  The study coordinator will present the participant with detailed instructions on how to 
begin each session.  The frequency of the sessions thereafter will be at the participant’s discretion 
according to the study’s requirements (daily practice). Mindfulness training will follow the protocol in 
the Muse-S app, which follows a standard breathing exercise with EEG brain state feedback through 
the mobile device, as designed by a panel of experienced mindfulness practitioners. In short the Muse-
S is a FitBit like device for the brain.    
 
The study participants can access 3 different types of meditation while using the Muse-S Headband 
system.  They are as follows: 
o Mind Meditation uses the Muse-S headband to track the user's brain activity during 
meditation and translates the brain's activity into guiding sounds. 
Users get real time feedback to know when their mind is focused 
and when it's distracted, and are cued to return to a state of 
focused attention (meditation state). Users also see data from 
their brain after the meditation. Real time feedback during Mind 
Meditation is the Muse-S signature meditation and teaches the 
fundamentals of a meditation practice- remaining in a calm 
focused attention state and being able to move your mind away 
from distracting thoughts. 
o Guided Meditations. Guided meditations are 
narrated meditations on a range of subjects like stress, focus, 
breath, and body practices.  
o Go-to-sleep Meditations use the headband and are guided meditations that can be 
combined with an audio sound scape generated from your biosignals (heart rate, brain, and 
movement). Sleep Journeys are designed to help you fall asleep faster. They are intended 
to be used in bed while you fall asleep to help calm your body and mind and entrain you 
into sleep. If you fall asleep with the headband on you can wear it through the night if you 
wish. Some people find Go-to-sleep journeys deeply relaxing and use them during the day 
as a relaxation tool as well.  
 
All study participants will have access to The Muse-S Headband system’s customer service team 
based in Toronto, Canada, by telephone and email for assistance should they experience technical 
problems with the device.  
o Server Data: As the patients complete the 10 minute sessions, the information from these 
sessions will be uploaded to the Muse-S secure cloud servers hosted by Google. 
Individual subject data will be visible to each subject at the end of each session, and data 
from the previous session stored in the “me” tab in the app. Study organizers will have 
ongoing access to each subject’s data to monitor compliance and performance. These data 
can include  the study-specific identification number, gender, and age of the subject, the 
time and duration of each session, EEG data, heart rate (PPG) data, and the performance 
(‘percent calm’) score per session. Interaxon’s privacy policy, which can be found at 
www.choosemuse.com/privacy will apply to Interaxon’s use of the subjects’ data. In order 
to maximize protection of the individual’s privacy, the study organizers will ensure that the 
subjects are assigned anonymized email address and names for use in the Muse -STM 
application and when contacting the Muse-STM customer support. To ensure that no health 

Muse and Fibromyalgia 
PI: S. Nanda, MD  
Mayo Clinic – NCT04720053 
 
 
 
 
 
 
 
 
Page 6 of 8 
 
data is shared with Interaxon, the study organizers have agreed to ensure that no health 
data will be shared with Interaxon.   
o 
Additionally, the data will be made available for aggregate download by specific members of the 
research team, from a secure server at regular intervals until and shortly after the study’s 
conclusion. The study coordinator may view the patient’s activity via a web browser. 
The Muse-S steps include: 1) Open the Muse-S  App on your phone. 2) select meditation type 3) if 
meditating with the headband, turn on the Muse-S  headband.  It will pair via Bluetooth to the app 4) put 
on headband (if doing a meditation with headband) 5) meditate for minimum of 5 minutes or longer 6) add 
any journal or mood entry if desired 7) review results.  
o 
Cleaning the Muse-S:  Each patient will be given a brand new, out-of-the-box Muse-S 
Headband system.  If cleaning must occur, the entire Muse-S including the head set can be 
wiped down with a standard disinfectant wipe.  The band can also be hand-washed gently with 
soap and water. The module on the band is not waterproof but can be wiped with disinfectant. 
 
Subject Retention:  
Participants will not be remunerated for participating in this study, but they will be allowed to keep the 
Muse-S™ Headbands. 
 
Resources:  
The data entry screens used will be developed via REDCap for the online forms.  Clinician investigators 
will provide medical oversight. The Muse-S Headband systems are provided at no cost through the 
manufacturer (InteraXon) for use during study participation.   
 
Check all that apply. If none apply, leave blank: 
  The research involves contact or interaction with subjects, for example, surveys, questionnaires, 
observation, blood draw. 
 
Study Design: 
We will use standardized procedures to ensure uniform instructions and support for all subjects for the 
recruitment, screening, and study entry.   
 
Recruitment: 
Subjects will be recruited from the Fibromyalgia Clinic.  The provider will inform patients of the study at 
time of their clinical appointment, and if the patient indicates interest the research staff will meet with the 
patient to begin the consent process.   
 
Consent and Screen: 
Study coordinator will meet with the potential subject who has expressed an interest in participating in the 
study.  The study coordinator will begin by introducing the study details, and after determining that the 
subject has continued interest in study participation, will move on to the study consent.  If the subject 
chooses to consent, the study coordinator will screen the participant for study entry inclusion/exclusion 
criteria.  If the study entry criteria are met, the subject will begin their study participation. They will be 
asked to complete the study surveys/questionnaires.  
 
Please note: Patients must have access to an iOS or Android capable device in order to take part in this 
study in order to interact with the Muse-S Headband system.   
 

Muse and Fibromyalgia 
PI: S. Nanda, MD  
Mayo Clinic – NCT04720053 
 
 
 
 
 
 
 
 
Page 7 of 8 
 
Treatment phase: 
During the first three months of study, subjects will be asked to complete the online study intervention, 
using the Muse-S headband. Patients will be contacted via telephone and online (REDCap) for study 
visits at day 14 and 30.  At day 90, they will be asked to return to the clinic for an in-person visit 
(telephone and online will be alternatives).  
 
Study Follow-Up Visits: 
The study will consist of a 6-month visit post baseline (3-month post end of intervention).  Patients will 
be asked to return to the clinic for an in-person visit, if possible (telephone and online will be the 
alternative).      
 
Subject Information 
 
Target accrual: We plan to recruit 43 patients diagnosed with fibromyalgia. 
 
Subject population:  A total of 43 adult patients diagnosed with fibromyalgia at Mayo Clinic that meet the 
following study criteria: 
 
Inclusion Criteria: 
1. 18 years of age or older at time of consent 
2. Diagnosed with Fibromyalgia 
3. Not pregnant by subject self-report at time of consent 
4. Have the ability to provide informed consent 
5. Have the ability to complete all aspects of this trial  
6. Have access to a  iPhone, iPad, Android device  
7. Has no contraindicating comorbid health condition as determined by the clinical investigators 
 
Exclusion Criteria:    
1. Used or been enrolled in any treatments for fibromyalgia or pain within the past 30 days, other than 
the Mayo Clinic Treatment program.  
2. Used an investigational drug within the past 30 days  
3. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis 
4. Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve 
quality of life or sleep. 
5. Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which 
intervenes on the patients’ QOL, sleep, or stress 
6. An unstable medical or mental health condition as determined by the physician investigator 
  
Review of medical records, images, specimens  
 
  The study involves data that exist at the time of IRB submission and data that will be generated after 
IRB submission.  
 
References 
1. 
Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014;311(15):1547-1555. 
2. 
Martin MY, Bradley LA, Alexander RW, et al. Coping strategies predict disability in patients with 
primary fibromyalgia. Pain. 1996;68(1):45-53. 

Muse and Fibromyalgia 
PI: S. Nanda, MD  
Mayo Clinic – NCT04720053 
 
 
 
 
 
 
 
 
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3. 
Triadafilopoulos G, Simms RW, Goldenberg DL. Bowel dysfunction in fibromyalgia syndrome. 
Dig Dis Sci. 1991;36(1):59-64. 
4. 
Whealy M, Nanda S, Vincent A, Mandrekar J, Cutrer FM. Fibromyalgia in migraine: a 
retrospective cohort study. J Headache Pain. 2018;19(1):61. 
5. 
Fietta P, Fietta P, Manganelli P. Fibromyalgia and psychiatric disorders. Acta Biomed. 
2007;78(2):88-95. 
6. 
Goldenberg DL. Psychologic studies in fibrositis. Am J Med. 1986;81(3A):67-70. 
7. 
Silverman SL, Harnett J, Zlateva G, Mardekian J. Identifying fibromyalgia-associated symptoms 
and conditions from a clinical perspective: a step toward evaluating healthcare resource utilization 
in fibromyalgia. Pain Pract. 2010;10(6):520-529. 
8. 
Toussaint LL, Whipple MO, Abboud LL, Vincent A, Wahner-Roedler DL. A mind-body 
technique for symptoms related to fibromyalgia and chronic fatigue. Explore (NY). 2012;8(2):92-
98. 
9. 
Kaplan KH, Goldenberg DL, Galvin-Nadeau M. The impact of a meditation-based stress reduction 
program on fibromyalgia. Gen Hosp Psychiatry. 1993;15(5):284-289. 
10. 
Millstine DM, Bhagra A, Jenkins SM, et al. Use of a Wearable EEG Headband as a Meditation 
Device for Women With Newly Diagnosed Breast Cancer: A Randomized Controlled Trial. Integr 
Cancer Ther. 2019;18:1534735419878770. 
11. 
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture 
(REDCap)--a metadata-driven methodology and workflow process for providing translational 
research informatics support. Journal of biomedical informatics. 2009;42(2):377-381. 
12. 
Woods NF, Lentz M, Mitchell E, Oakley LD. Depressed mood and self-esteem in young Asian, 
black, and white women in America. Health Care Women Int. 1994;15(3):243-262. 
13. 
Hyland M, Sodergren S. Development of a new type of global quality of life scale, and 
comparison of performance and preference for 12 global scales. Qual Life Res. 1996;5(5):469-480. 
14. 
Dyrbye LN, Thomas MR, Huschka MM, et al. A multicenter study of burnout, depression, and 
quality of life in minority and nonminority US medical students. Mayo Clinic proceedings Mayo 
Clinic. 2006;81(11):1435-1442. 
15. 
Locke DE, Decker PA, Sloan JA, et al. Validation of single-item linear analog scale assessment of 
quality of life in neuro-oncology patients. J Pain Symptom Manage. 2007;34(6):628-638. 
16. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 
1983;24(4):385-396. 
17. 
Cohen S. Perceived stress in a probability sample of the United States. Newbury Park, CA1988. 
18. 
Wolfe F, Clauw DJ, Fitzcharles MA, et al. 2016 Revisions to the 2010/2011 fibromyalgia 
diagnostic criteria. Semin Arthritis Rheum. 2016;46(3):319-329. 
19. 
Chauhan C, Atherton PJ. Patient satisfaction with participation in phase II/III NCCTG clinical 
trials: Was it worth it? (N0392). . J Clin Oncology. 2012a;30(15_Supplement):6133.