Fibromyalgia
Conditions
Brief summary
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
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.
Interventions
DEVICEWearable brain sensing wellness device headband system
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Widespread Pain Index (WPI) | Baseline to end of treatment (day 90) | Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 body areas where the patient feels pain over the prior week. Each area identified on the list counts as 1. The range on the WPI score can range from 0 to 19. With lower number indicating fewer areas of pain (hence lower pain). The difference is calculated by taking the baseline score minus the end of treatment score. |
| Change in Perceived Stress Scale | Baseline to end of treatment (day 90) | Measured on a 0-10 pain assessment scale. Participants rate their stress on a scale of 0 to 10. Zero means no stress, and 10 means the worst possible stress. The difference is calculated by taking the baseline score minus the end of treatment score. |
Countries
United States
Participant flow
Recruitment details
Potential participants were patients diagnosed with fibromyalgia at a large healthcare facility in the Midwestern United States. Enrollment took place from November 01, 2021 to January 27, 2023. Study participation concluded on July 28, 2023.
Pre-assignment details
After consent, one participant was found not to meet study entry criteria (no mobile device) and had to be removed from study.
Participants by arm
| Arm | Count |
|---|---|
| Wearable Brain Sensing Wellness Device Headband System 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.
Wearable brain sensing wellness device headband system: Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 12 |
Baseline characteristics
| Characteristic | Wearable Brain Sensing Wellness Device Headband System |
|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex/Gender, Customized female | 33 Participants |
| Sex/Gender, Customized male | 6 Participants |
| Sex/Gender, Customized other | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Change in Perceived Stress Scale
Measured on a 0-10 pain assessment scale. Participants rate their stress on a scale of 0 to 10. Zero means no stress, and 10 means the worst possible stress. The difference is calculated by taking the baseline score minus the end of treatment score.
Time frame: Baseline to end of treatment (day 90)
Population: Participants with measurements at both baseline and end of treatment (day 90)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wearable Brain Sensing Wellness Device Headband System | Change in Perceived Stress Scale | 4.1 units on a scale | Standard Deviation 6.04 |
Primary
Change in Widespread Pain Index (WPI)
Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 body areas where the patient feels pain over the prior week. Each area identified on the list counts as 1. The range on the WPI score can range from 0 to 19. With lower number indicating fewer areas of pain (hence lower pain). The difference is calculated by taking the baseline score minus the end of treatment score.
Time frame: Baseline to end of treatment (day 90)
Population: Those with complete data at both baseline and end of treatment (day 90)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wearable Brain Sensing Wellness Device Headband System | Change in Widespread Pain Index (WPI) | 1.4 units on a scale | Standard Deviation 2.8 |