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

NCT04944459 | Completed

• 1 other identifier: MUSE-PAIN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Changes in PROMIS-29 scores relative to baseline.

  Changes from PROMIS-29 scores relative to baseline for each domain evaluated (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity). The first seven domains are assessed with 4 questions each; Pain Intensity is measured with a single 11-point numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain). High scores represent more of the domain being measured. Thus, on symptom-oriented (negatively-worded) domains of PROMIS-29 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent worse symptomatology. On the function-oriented (positively-worded) domains (physical functioning and social role) higher scores represent better functioning.

  Baseline, 7 weeks, 6- and 12 months

• Change in Pain Impact Score (PIS) (calculated from PROMIS-29) relative to baseline.

  The Pain Impact Score (PIS) is a derivative of the PROMIS-29 that ranges from 8 (low impact) to 50 (high impact). The PIS is calculated by adding the raw scores for pain intensity \[0-10\] and pain interference \[4-20\] along with the inverted raw score for physical function \[4-20\].

  Baseline, 7 weeks, 6- and 12 months

• Change in Patient Global Impression of Change (PGIC) relative to baseline.

  Subjects will be asked if their overall pain was very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.

  7 weeks, 6- and 12 months

Secondary Outcomes (5)

• Change in Numeric Rating Scale (NRS) by pain area(s) relative to baseline.

  Baseline, 7 weeks, 6- and 12 months

• Percent Pain Relief (PPR) by pain area(s) relative to baseline.

  7 weeks, 6- and 12 months

• Impact of study intervention on Pain Catastrophizing by assessing change in Pain Catastrophizing Scale (PCS) relative to baseline.

  Baseline, 7 weeks, 6- and 12 months

• Patient Engagement

  7 weeks

• Patient Satisfaction

  7 weeks, 6-, and 12-months

Other Outcomes (3)

• Changes in Heart Rate Variability (HRV) during and after cold pressor test (acute phase), and after completion of protocol (chronic phase)

  Baseline and 7 weeks

• Changes in Peak Alpha Frequency during and after cold pressor test (acute phase), and after completion of protocol (chronic phase)

  Baseline and 7 weeks

• Changes in cold pressor test time in seconds during cold pressor test (acute phase), and after completion of protocol (chronic phase)

  Baseline and 7 weeks

Study Arms (1)

Muse-S

EXPERIMENTAL

multi-sensor neurofeedback-assisted mindfulness training device (Muse-S)

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

Interventions

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

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.

Muse-S

Eligibility Criteria

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

You may qualify if:

• Subject must be able to provide written informed consent prior to any clinical study-related procedure.
• 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.
• Subject has had a chronic painful condition for more than 3 months.
• 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).
• Subject is naïve to the regular practice of any form of meditation.
• 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.)
• 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).
• 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.

You may not qualify if:

• 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, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator (e.g., another clinical or research program which intervenes on the patient's pain, stress, anxiety or Quality of Life).
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements (e.g., cognitive deficits, history of head injury or a neuropsychological or psychiatric condition or use of psychoactive drugs that may influence the functioning of the central nervous system).
• Any condition that would preclude the subject from participating in cold pressor testing 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 bone fracture on or near their hand to be submersed.
• Subject frequently engages in cold therapy (practice of using cold water or ice baths to treat health conditions or stimulate health benefits (also known as cold hydrotherapy).

Sponsors & Collaborators

• Center For Interventional Pain and Spine: lead
• InteraXon: collaborator
• Celéri Health, Inc.: collaborator

Study Sites (2)

Pacific Research Institute, LLC

Santa Rosa, California, 95403, United States

Location

Center For Interventional Pain and Spine

Lancaster, Pennsylvania, 17601, United States

Location

Related Links

• Center For Interventional Pain and Spine

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Fishman, MD

  Center For Interventional Pain and Spine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 29, 2021
• Study Start: July 12, 2021
• Primary Completion: November 14, 2022
• Study Completion: October 19, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)