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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable brain sensing wellness device headband system | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable brain sensing wellness device headband system | Device | Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of treatment (day 90) |
| 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. | Baseline to end of treatment (day 90) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjeev Nanda, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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After consent, one participant was found not to meet study entry criteria (no mobile device) and had to be removed from study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Those with complete data at both baseline and end of treatment (day 90) | Posted | Mean | Standard Deviation | units on a scale | Baseline to end of treatment (day 90) |
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The time frame was from the start of the study till the end of study, which was a 6 month period.
Adverse Events were collected at the baseline visit and all other visits during the study period. At the end of study visit (6 months) only serious adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjeev Nanda | Mayo Clinic | 507-284-9919 | GIMRESEARCHSTUDIES@Mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2024 | Aug 19, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2024 | Aug 19, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
|
| 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. | Participants with measurements at both baseline and end of treatment (day 90) | Posted | Mean | Standard Deviation | units on a scale | Baseline to end of treatment (day 90) |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D009422 |
| Nervous System Diseases |