Paresthesia-Free Fast-Acting Subperception (FAST) Study

Chronic Pain Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04618471
• Other study ID #: A4099
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: September 2026

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 177
• Est. completion date: September 2026
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Paresthesia

Intervention

Device:
• Boston Scientific WaveWriter SCS System
WaveWriter SCS Programming

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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