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

Last updated: February 28, 2024
Sponsor: Center For Interventional Pain and Spine
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

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

Clinical Study ID

NCT04944459
MUSE-PAIN
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must be able to provide written informed consent prior to any clinicalstudy-related procedure.
  2. Subject is at least 18 years (or the minimum age required by local law to consent forparticipation 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 Musetherapy (i.e., no changes to any medical device(s) used or pharmaceutical agentsadministered 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 forcompletion of study-related assessments and interventions:
  • Access to an iPhone, iPad or Android capable device and/or computer for thepurposes of electronically completing patient self-reported questionnaires viaSMS text or email.
  • Access to an iPhone or iPad (i.e., an Apple device) in order to interact with theMuse-S Headband system, the Muse App and the Meditation Studio App. Refer to thefollowing link for details regarding which Apple devices are compatible withMuse: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, canonly accommodate Apple devices. Therefore, only Subjects with access to an Appledevice can initially be enrolled. However, there are future plans to also havethe pain course available on the Muse App. Once the pain course is available onthe Muse App, the Meditation Studio App will no longer be needed and Subjectswith Android devices will also be eligible for participation at that time.)
  1. Subject has medical clearance to perform activities that somebody of their age andlevel of physical fitness could reasonably do without doing irreparable damage totheir body (i.e., patient will not be harmed if they resume normal activity uponalleviation of any of their pain).
  2. Subject, in the opinion of the Investigator, is able to understand this clinicalinvestigation, cooperate with the investigational procedures, operate the Muse-Sdevice, and is willing to complete remote assessments and return for follow-up.

Exclusion

Exclusion Criteria:

  1. Subject is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, oradditional testing beyond standard of care procedures) which could confound theresults of this trial as determined by the investigator (e.g., another clinical orresearch program which intervenes on the patient's pain, stress, anxiety or Quality ofLife).
  2. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements (e.g., cognitive deficits, history of head injury or aneuropsychological or psychiatric condition or use of psychoactive drugs that mayinfluence the functioning of the central nervous system).
  3. Any condition that would preclude the subject from participating in cold pressortesting based on the investigator's opinion such as history of Raynaud's phenomena,syncope, cardiovascular disorder, or frostbite or has an open cut, sore, or bonefracture on or near their hand to be submersed.
  4. Subject frequently engages in cold therapy (practice of using cold water or ice bathsto treat health conditions or stimulate health benefits (also known as coldhydrotherapy).

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Muse-S headband; InteraXon Inc., RRID:SCR_014418
Phase:
Study Start date:
July 12, 2021
Estimated Completion Date:
October 19, 2023

Study Description

This clinical investigation is a prospective, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on the use of the Muse-S headband system in patients with chronic pain.

Adult chronic pain patients without systematic meditation experience will be eligible to participate in this study.

After signing the informed consent form (ICF), patients will enter the screening/baseline period. Screening/baseline assessments will include data collection (including previous Electronic Medical Record (EMR) data), patient self-reported questionnaires and cold pressor testing.

Subjects will receive and be trained on the Muse-S headband system and will be asked to perform daily assigned intervention with the Muse device for 7 weeks during the main study period, which will include at a minimum achieving 2 new chapters per week in the pain course until the pain course is completed, a minimum of Muse mind sessions 3 times per week at a minimum of 5 minutes per session and engagement with the Muse system at a minimum of 5 times per week once the pain course is complete. Patients will be instructed to do Muse Mind Meditation on the Muse App for a minimum of 5 minutes daily and will be required to complete the entire pain course content during the main study period. Functional device data will be collected during all Muse sessions. In addition, study participants have the option to use the Muse-S go to sleep journey and to sleep with the device if they are comfortable doing so in order in order to provide data on their sleep sessions.

During this main study period, investigative sites will follow up with study participants after baseline to answer any study-related questions and assess for any device-related AEs, which will include two follow up telephone calls at day 3 (± 1 day) and week 4 (± 3 day) to assess patient satisfaction and their ability to use the device. In addition, subjects will be required to respond remotely to patient self-reported questionnaires on a weekly basis.

The main study portion for a study participant will end when the final main study visit is completed [7 weeks post start of study intervention (±1 week)], which will include cold pressor testing.

Following completion of the main study, subjects will be encouraged to continue using their Muse-S device for the next 12 months during a study extension period. During this extension period, functional device data will be collected following all Muse-S sessions with patient self-reported questionnaires and EMR data collection at 6 and 12 months.

Connect with a study center

  • Pacific Research Institute, LLC

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Center For Interventional Pain and Spine

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

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