Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-27 @ 1:13 PM
Study NCT ID:
NCT04944459
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2021-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation Utilizing Signals From Electroencephalography in Chronic Pain (MUSE-PAIN) Study
Sponsor:
Center For Interventional Pain and Spine
Organization:
Study Overview
Official Title:
Meditation Utilizing Signals From Electroencephalography in Chronic Pain (MUSE-PAIN) Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: