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Behavioural Intervention
Muse-S headband; InteraXon Inc., RRID:SCR_014418 for Chronic Pain
N/A
Waitlist Available
Led By Michael Fishman, MD
Research Sponsored by Center For Interventional Pain and Spine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks, 6- and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial uses the Muse-S headband to help adults with chronic pain meditate. The headband guides users through meditation exercises and provides feedback to improve their practice, aiming to reduce their pain.
Eligible Conditions
- Chronic Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks, 6- and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks, 6- and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain Impact Score (PIS) (calculated from PROMIS-29) relative to baseline.
Change in Patient Global Impression of Change (PGIC) relative to baseline.
Changes in PROMIS-29 scores relative to baseline.
Secondary study objectives
Change in Numeric Rating Scale (NRS) by pain area(s) relative to baseline.
Impact of study intervention on Pain Catastrophizing by assessing change in Pain Catastrophizing Scale (PCS) relative to baseline.
Patient Engagement
+2 moreOther study objectives
Changes in cold pressor test time in seconds during cold pressor test (acute phase), and after completion of protocol (chronic phase)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Muse-SExperimental Treatment1 Intervention
multi-sensor neurofeedback-assisted mindfulness training device (Muse-S)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Muse-S headband; InteraXon Inc., RRID:SCR_014418
2021
N/A
~50
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Who is running the clinical trial?
Center For Interventional Pain and SpineLead Sponsor
3 Previous Clinical Trials
350 Total Patients Enrolled
1 Trials studying Chronic Pain
120 Patients Enrolled for Chronic Pain
InteraXonUNKNOWN
Celéri Health, Inc.Industry Sponsor
2 Previous Clinical Trials
328 Total Patients Enrolled
2 Trials studying Chronic Pain
328 Patients Enrolled for Chronic Pain
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