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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

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks, 6- and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks, 6- and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 more
Other outcome measures
Changes in Heart Rate Variability (HRV) during and after cold pressor test (acute phase), and after completion of protocol (chronic phase)
Changes in Peak Alpha Frequency during and after cold pressor test (acute phase), and after completion of protocol (chronic phase)
Changes in cold pressor test time in seconds during cold pressor test (acute phase), and after completion of protocol (chronic phase)

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

Find a Location

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
673 Total Patients Enrolled
2 Trials studying Chronic Pain
673 Patients Enrolled for Chronic Pain
~12 spots leftby Sep 2025
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