Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

Study Overview
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Brief Summary
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The purpose of this study is to study the feasibility of a wearable brain sensing wellness device to provide mindfulness training to fibromyalgia patients who have failed medical therapy.

Detailed Description
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All study participants will receive a wearable brain sensing wellness device, and demonstration of the mindfulness sessions. Participants will be asked to complete study surveys/questionnaires. During the first part of study, participants will be asked to complete the intervention. After completion of the intervention they will enter a follow-Up Phase, where they will be contacted and asked to complete surveys and gauge satisfaction with the study.

Official Title
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A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing- A Wearable Wellness Brain Sensing Device (Muse-S) in Newly Diagnosed Fibromyalgia Patients.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Wearable brain sensing wellness device headband system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older at time of consent. Diagnosed with Fibromyalgia. Not pregnant by subject self-report at time of consent. Have the ability to provide informed consent. Have the ability to complete all aspects of this trial. Have access to a iPhone, iPad, Android device. Has no contraindicating comorbid health condition as determined by the clinical investigators. Exclusion Criteria: Used or been enrolled in any treatments for fibromyalgia, or pain within the past 30 days. Used an investigational drug within the past 30 days. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis. Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life. Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress. An unstable medical or mental health condition as determined by the physician investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable brain sensing wellness device headband system<br>Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session. | Device: Wearable brain sensing wellness device headband system<br>* Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wide pain index (WPI) | Wide pain index (WPI) 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 | Baseline, end of treatment day 90, and at the end of study day 180 | 
| Change in symptom severity score | Measured on a 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. | Baseline, end of treatment day 90, and at the end of study day 180 |