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Meditation Utilizing Signals From Electroencephalography in Chronic Pain (MUSE-PAIN) Study

NCT04944459 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-29

No results posted yet for this study

Summary

This clinical investigation is a prospective, open-label, non-randomized, multi-center study. It is designed to assess the use of the Muse-S meditation system in patients with chronic pain based on clinical follow-up data and exploratory cold pressor testing.

Baseline assessments will be taken prior to exposure to Muse-S. Subjects will be followed for 7 weeks for main study endpoints and will continue to be followed through 12 months during a study extension period.

Conditions

Interventions

DEVICE

Muse-S headband; InteraXon Inc., RRID:SCR_014418

Muse-S is used as a technology-supported Mindfulness Training (tsMT) device as a way to introduce meditation as a method for managing chronic pain in individuals as it facilitates the learning process, requires minimal training to use and provides mechanisms to enhance compliance and track progress. The availability of direct feedback data from Muse-S may encourage the participant to perform meditation sessions and may increase time spent in the "calm" brain state.

Sponsors & Collaborators

  • InteraXon

    collaborator UNKNOWN

  • Celéri Health, Inc.

    collaborator INDUSTRY

  • Center For Interventional Pain and Spine

    lead OTHER

Principal Investigators

  • Michael Fishman, MD · Center For Interventional Pain and Spine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2022-11-14
Completion
2023-10-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944459 on ClinicalTrials.gov