Ireland
--:--IST
Recruiting Not applicable

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

NCT07190807 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2025-11-07
Last updated
2026-10-13

Condition(s) studied

Chronic PainIntractable PainLow Back PainChronic Low-back PainChronic Leg PainLeg Pain

Investigational drug(s) / intervention(s)

Boston Scientific WaveWriter Alpha™ SCS Systems

Boston Scientific WaveWriter Alpha™ SCS Systems: Time Varied Pulse (TVP)-SCS settings

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Targeted Pain Responder Rate — 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

Trial sites (7)

FacilityCityRegionStatus
Denver Back Pain Specialists Greenwood Colorado Recruiting
Orlando Health Neuroscience Institute Clermont Florida Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Fox Chase Pain Management Trevose Pennsylvania Recruiting
PCPMG Clinical Research Unit, LLC Greenville South Carolina Recruiting
Institute of Precision Pain Medicine Corpus Christi Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07190807 on ClinicalTrials.gov ↗ ← All trials in the USA