Paresthesia-Free Fast-Acting Subperception (FAST) Study (FAST)

June 9, 2026 updated by: Boston Scientific Corporation

Study to Demonstrate the Value of Paresthesia-Free Fast-Acting Subperception (FAST) and Other SCS Therapies Using WaveWriter™ Spinal Cord Stimulator Systems in the Treatment of Chronic Pain

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palm Desert, California, United States, 92260
        • Vitamed Research
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Denver Back Pain Specialists
    • Florida
      • Clermont, Florida, United States, 34711
        • Orlando Health Neuroscience Institute
      • Gainesville, Florida, United States, 32607
        • The Orthopaedic Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Goodman Campbell Brain and Spine
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Willis-Knighton River Cities Clinical Research Center
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Sports and Spine, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • PCPMG Clinical Research Unit, LLC
    • Washington
      • Bellevue, Washington, United States, 98005
        • Acute and Chronic Pain Therapies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WaveWriter Settings
Device: Boston Scientific WaveWriter SCS System
WaveWriter SCS Programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months post-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Actual)

December 14, 2022

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

October 31, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4099

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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