NCT04618471

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
35mo left

Started Feb 2021

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Feb 2021Mar 2029

First Submitted

Initial submission to the registry

October 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 29, 2023

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Expected
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

October 31, 2020

Results QC Date

December 14, 2023

Last Update Submit

March 4, 2026

Conditions

Chronic Pain

Keywords

Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

  • Targeted Pain Responder Rate

    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

Study Arms (1)

WaveWriter Settings

EXPERIMENTAL
Device: Boston Scientific WaveWriter SCS System

Interventions

Boston Scientific WaveWriter SCS SystemDEVICE

WaveWriter SCS Programming

WaveWriter Settings

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Vitamed Research

Palm Desert, California, 92260, United States

Location

Denver Back Pain Specialists

Greenwood Village, Colorado, 80111, United States

Location

Orlando Health Neuroscience Institute

Clermont, Florida, 34711, United States

Location

The Orthopaedic Institute

Gainesville, Florida, 32607, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Goodman Campbell Brain and Spine

Carmel, Indiana, 46032, United States

Location

Willis-Knighton River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Pacific Sports and Spine, LLC

Eugene, Oregon, 97401, United States

Location

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

Location

Acute and Chronic Pain Therapies

Bellevue, Washington, 98005, United States

Location

Related Publications (1)

  • Anitescu M, Loudermilk E, North J, Wahezi S, Antony A, Leier T, Trainor D, Noles J, Moore G, Lee J, Paez J, Wilson D, Van Belleghem V, Goldberg E. Pain Relief and Multidimensional Outcomes of Fast-Acting Subperception Spinal Cord Stimulation Therapy for Chronic Pain: The FAST Prospective, Multicenter Study. Pain Ther. 2026 Mar 10. doi: 10.1007/s40122-026-00823-0. Online ahead of print.

    PMID: 41803572DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sr. Director, Clinical Operations
Organization
Boston Scientific Corporation
BSNClinicalTrials@bsci.com
855-213-9890

Study Officials

  • Natalie Bloom Lyons

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2020

First Posted

November 6, 2020

Study Start

February 10, 2021

Primary Completion

December 14, 2022

Study Completion (Estimated)

March 1, 2029

Last Updated

March 5, 2026

Results First Posted

December 29, 2023

Record last verified: 2026-03

Locations

US(13)