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Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04720053
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
Sanjeev Nanda, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Wearable brain sensing wellness device headband system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing- A Wearable Wellness Brain Sensing Device (Muse-S) in Newly Diagnosed Fibromyalgia Patients.
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: 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.
Device: Wearable brain sensing wellness device headband system
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.




Primary Outcome Measures :
  1. Change in wide pain index (WPI) [ Time Frame: Baseline, end of treatment day 90, and at the end of study day 180 ]
    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

  2. Change in symptom severity score [ Time Frame: Baseline, end of treatment day 90, and at the end of study day 180 ]
    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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720053


Contacts
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Contact: Jennifer Soderlind (507) 284-4799 GIMRESEARCHSTUDIES@Mayo.edu
Contact: Shawn Fokken (507) 293-2740 GIMRESEARCHSTUDIES@Mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Soderlind       soderlind.jennifer@mayo.edu   
Contact: Jennifer Hanson       hanson.jennifer6@mayo.edu   
Principal Investigator: Sanjeev Nanda         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Sanjeev Nanda, MD Mayo Clinic
Additional Information:
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Responsible Party: Sanjeev Nanda, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04720053    
Other Study ID Numbers: 20-003020
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases