Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720053
• Other study ID #: 20-003020
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 28, 2023

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Wearable brain sensing wellness device headband system
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials