Meditation Utilizing Signals From Electroencephalography in Chronic Pain (MUSE-PAIN) Study
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|ClinicalTrials.gov Identifier: NCT04944459|
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : August 25, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Device: Muse-S headband; InteraXon Inc., RRID:SCR_014418||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Meditation Utilizing Signals From Electroencephalography in Chronic Pain (MUSE-PAIN) Study|
|Actual Study Start Date :||July 12, 2021|
|Estimated Primary Completion Date :||January 24, 2022|
|Estimated Study Completion Date :||December 6, 2022|
multi-sensor neurofeedback-assisted mindfulness training device (Muse-S)
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.
- Changes in PROMIS-29 scores relative to baseline. [ Time Frame: Baseline, 7 weeks, 6- and 12 months ]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.
- Change in Pain Impact Score (PIS) (calculated from PROMIS-29) relative to baseline. [ Time Frame: Baseline, 7 weeks, 6- and 12 months ]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].
- Change in Patient Global Impression of Change (PGIC) relative to baseline. [ Time Frame: 7 weeks, 6- and 12 months ]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.
- Change in Numeric Rating Scale (NRS) by pain area(s) relative to baseline. [ Time Frame: Baseline, 7 weeks, 6- and 12 months ]Patients will be asked to rate their pain area(s) using a 0 to 10 numeric rating scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
- Percent Pain Relief (PPR) by pain area(s) relative to baseline. [ Time Frame: 7 weeks, 6- and 12 months ]Patients will be asked on a scale of 0-100, with 100% being complete relief and 0% being no relief, how much relief from their pain area(s).
- Impact of study intervention on Pain Catastrophizing by assessing change in Pain Catastrophizing Scale (PCS) relative to baseline. [ Time Frame: Baseline, 7 weeks, 6- and 12 months ]The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking (degree to which people experience an aversive orientation towards pain) according to 3 components: rumination, magnification, and helplessness. It consists of 13 items rated on a 0-4 scale, with a total range of 0 to 52. Respondents will rate the frequency in which they experience such thoughts on a scale ranging from 0 (not at all) to 4 (all the time). A lower score indicates a better result.
- Patient Engagement [ Time Frame: 7 weeks ]Adherence to Muse use by summarizing the frequency of use.
- Patient Satisfaction [ Time Frame: 7 weeks, 6-, and 12-months ]Patients will be asked a series of Patient Satisfaction and Engagement Questions where they will respond to questions using a five point Likert Scale (Strongly Agree; Agree; Neutral; Disagree; Strongly Disagree).
- Changes in Heart Rate Variability (HRV) during and after cold pressor test (acute phase), and after completion of protocol (chronic phase) [ Time Frame: Baseline and 7 weeks ]
- Changes in Peak Alpha Frequency during and after cold pressor test (acute phase), and after completion of protocol (chronic phase) [ Time Frame: 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) [ Time Frame: Baseline and 7 weeks ]Cold pain threshold - time to the first report of pain and cold pain tolerance - time to removal of the hand from the ice bath (measured in seconds postsubmersion).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944459
|Contact: Ashley Schererfirstname.lastname@example.org|
|Contact: Ashley Katsarakesemail@example.com|
|United States, California|
|Pacific Research Institute, LLC||Recruiting|
|Santa Rosa, California, United States, 95403|
|Contact: Adrian Marquez firstname.lastname@example.org|
|Principal Investigator: Jason Pope, MD|
|United States, Pennsylvania|
|Center For Interventional Pain and Spine||Recruiting|
|Lancaster, Pennsylvania, United States, 17601|
|Contact: Ashley Scherer 302-750-3099 email@example.com|
|Principal Investigator: Michael Fishman, MD|
|Principal Investigator:||Michael Fishman, MD||Center For Interventional Pain and Spine|