Clinical trial NCT04618471: Paresthesia-Free Fast-Acting Subperception (FAST) Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Spinal Cord Stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 177
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Targeted Pain Responder Rate
timeFrame: 3 months post-activation
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Vitamed Research
state: California
city: Greenwood Village
country: United States
facility: Denver Back Pain Specialists
state: Colorado
city: Clermont
country: United States
facility: South Lake Pain Institute, Inc
state: Florida
city: Gainesville
country: United States
facility: The Orthopaedic Institute
state: Florida
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Carmel
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Clinical Research Center
state: Louisiana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
city: Bellevue
country: United States
facility: Acute and Chronic Pain Therapies
state: Washington
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: