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

CompletedNot applicableNCT04944459
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Meditation Utilizing Signals From Electroencephalography in Chronic Pain (MUSE-PAIN) Study
Conditions
Interventions
  • Device: Muse-S headband
  • InteraXon Inc., RRID:SCR_014418
Sponsor
Center For Interventional Pain and Spine
Collaborators
InteraXon; Celéri Health, Inc.
Start date
2021-07-12
Primary completion
2022-11-14
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Subject must be able to provide written informed consent prior to any clinical study-related procedure. 2. Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment. 3. Subject has had a chronic painful condition for more than 3 months. 4. Subject is on stable background treatment for at least 6 weeks prior to starting Muse therapy (i.e., no changes to any medical device(s) used or pharmaceutical agents administered for pain, mood, sleep or spasm, including change to dose or interval). 5. Subject is naïve to the regular practice of any form of meditation. 6. Subject has access to the following personal devices with regular internet access for completion of study-related assessments and interventions: * Access to an iPhone, iPad or Android capable device and/or computer for the purposes of electronically completing patient self-reported questionnaires via SMS text or email. * Access to an iPhone or iPad (i.e., an Apple device) in order to interact with the Muse-S Headband system, the Muse App and the Meditation Studio App. Refer to the following link for details regarding which Apple devices are compatible with Muse: https://choosemuse.force.com/s/article/What-devices-are-compatible-with-Muse?language=en\_US. (NOTE: Meditation Studio App, which is used for the pain course, can only accommodate Apple devices. Therefore, only Subjects with access to an Apple device can initially be enrolled. However, there are future plans to also have the pain course available on the Muse App. Once the pain course is available on the Muse App, the Meditation Studio App will no longer be needed and Subjects with Android devices will also be eligible for participation at that time.) 7. Subject has medical clearance to perform activities that somebody of their age and level of physical fitness could reasonably do without doing irreparable damage to their body (i.e., patient will not be harmed if they resume normal activity upon alleviation of any of their pain). 8. Subject, in the opinion of the Investigator, is able to understand this clinical investigation, cooperate with the investigational procedures, operate the Muse-S device, and is willing to complete remote assessments and return for follow-up. Exclusion Criteria: 1. Subject is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04944459