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Recruiting

NCT Number: NCT07190807

Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control

Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).

In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Back Pain Specialists, Greenwood, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis.
  • Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months.
  • 18 years of age or older when written informed consent is obtained
  • Able to independently read and complete all questionnaires and assessments provided in English.
  • Signed a valid, IRB or EC approved informed consent form (ICF) provided in English.

Key Exclusion Criteria:

  • Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).
  • Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
  • A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
  • Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.

Treatment and study plan

Boston Scientific WaveWriter Alpha™ SCS Systems

Device

Time Varied Pulse (TVP)-SCS settings

Primary outcomes

  1. Targeted Pain Responder Rate

    Time frame: 3 months post-activation

    Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Keesey

CONTACT

[email protected]

855-213-9890

Thanh Hoang

CONTACT

[email protected]

855-213-9890

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)

Acronym: MOSAIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Sep 24, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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