Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

NCT04720053 | Completed Results FDA Device

• 1 other identifier: 20-003020
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

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.

Device: Wearable brain sensing wellness device headband system

Interventions

Wearable brain sensing wellness device headband system DEVICE

Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.

Wearable brain sensing wellness device headband system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Sanjeev Nanda
• Organization: Mayo Clinic

GIMRESEARCHSTUDIES@Mayo.edu

507-284-9919

Study Officials

• Sanjeev Nanda, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: November 1, 2021
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)