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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject must be able to provide written informed consent prior to any clinicalstudy-related procedure.
- 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.
- 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 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).
- Subject is naïve to the regular practice of any form of meditation.
- 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.)
- 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).
- 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:
- 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).
- 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).
- 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.
- 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
Connect with a study center
Pacific Research Institute, LLC
Santa Rosa, California 95403
United StatesSite Not Available
Center For Interventional Pain and Spine
Lancaster, Pennsylvania 17601
United StatesSite Not Available
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