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Clinical Trials in the USA / NCT04618471
Active, not recruiting Not applicable

Paresthesia-Free Fast-Acting Subperception (FAST) Study

NCT04618471 · tracked via the Priya Life Science USA tracker
Sponsor
Boston Scientific Corporation
Phase
Not applicable
Started
2021-02-10
Last updated
2026-10-09

Condition(s) studied

Chronic Pain

Investigational drug(s) / intervention(s)

Boston Scientific WaveWriter SCS System

Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming

Study summary

Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain. * 22 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-approved informed consent form (ICF) provided in English Key Exclusion Criteria: * Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes * Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study * Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception * Participating, or intends to participate, in another 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 (13)

FacilityCityRegionStatus
Vitamed Research Palm Desert California
Denver Back Pain Specialists Greenwood Village Colorado
Orlando Health Neuroscience Institute Clermont Florida
The Orthopaedic Institute Gainesville Florida
University of Chicago Hospital Chicago Illinois
Goodman Campbell Brain and Spine Carmel Indiana
Willis-Knighton River Cities Clinical Research Center Shreveport Louisiana
Montefiore Medical Center The Bronx New York
The Center for Clinical Research Winston-Salem North Carolina
Cleveland Clinic Foundation Cleveland Ohio
Pacific Sports and Spine, LLC Eugene Oregon
PCPMG Clinical Research Unit, LLC Greenville South Carolina
Acute and Chronic Pain Therapies Bellevue Washington

More Boston Scientific Corporation trials in the USA

Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain Recruiting
IT Matters: The Erectile Restoration Registry Enrolling by invitation
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area Recruiting
ADVENT Post Approval Study Active, not recruiting
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control Recruiting

Other trials for the same condition

Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy Enrolling by invitation
Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2) Active, not recruiting
Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT) Active, not recruiting
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control Recruiting
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy 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 NCT04618471 on ClinicalTrials.gov ↗ ← All trials in the USA