Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT04944459
Eligibility Criteria:
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 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).
2. 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).
3. 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.
4. 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04944459
Study Brief:
Protocol Section:
NCT04944459