Paresthesia-Free Fast-Acting Subperception (FAST) Study (FAST)
September 3, 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
-
-
California
-
Palm Desert, California, United States, 92260
- Vitamed Research
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Colorado
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Greenwood Village, Colorado, United States, 80111
- Denver Back Pain Specialists
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Florida
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Clermont, Florida, United States, 34711
- Orlando Health Neuroscience Institute
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Gainesville, Florida, United States, 32607
- The Orthopaedic Institute
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Hospital
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Indiana
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Carmel, Indiana, United States, 46032
- Goodman Campbell Brain and Spine
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-
Louisiana
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Shreveport, Louisiana, United States, 71105
- Willis-Knighton River Cities Clinical Research Center
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New York
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The Bronx, New York, United States, 10461
- Montefiore Medical Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- The Center for Clinical Research
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Oregon
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Eugene, Oregon, United States, 97401
- Pacific Sports and Spine, LLC
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South Carolina
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Greenville, South Carolina, United States, 29601
- PCPMG Clinical Research Unit, LLC
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Washington
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Bellevue, Washington, United States, 98005
- Acute and Chronic Pain Therapies
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-
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
|
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
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.
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)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 3, 2026
Last Verified
September 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.