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Paresthesia-Free Fast-Acting Subperception (FAST) Study

NCT ID: NCT04618471

Last Updated: 2025-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Keywords

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Spinal Cord Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WaveWriter Settings

Group Type EXPERIMENTAL

Boston Scientific WaveWriter SCS System

Intervention Type DEVICE

WaveWriter SCS Programming

Interventions

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Boston Scientific WaveWriter SCS System

WaveWriter SCS Programming

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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Vitamed Research

Palm Desert, California, United States

Site Status

Denver Back Pain Specialists

Greenwood Village, Colorado, United States

Site Status

Orlando Health Neuroscience Institute

Clermont, Florida, United States

Site Status

The Orthopaedic Institute

Gainesville, Florida, United States

Site Status

University of Chicago Hospital

Chicago, Illinois, United States

Site Status

Goodman Campbell Brain and Spine

Carmel, Indiana, United States

Site Status

Willis-Knighton River Cities Clinical Research Center

Shreveport, Louisiana, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Pacific Sports and Spine, LLC

Eugene, Oregon, United States

Site Status

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, United States

Site Status

Acute and Chronic Pain Therapies

Bellevue, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A4099

Identifier Type: -

Identifier Source: org_study_id