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NCT Number: NCT04618471

Paresthesia-Free Fast-Acting Subperception (FAST) Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitamed Research, Palm Desert, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Boston Scientific WaveWriter SCS System

Device

WaveWriter SCS Programming

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study 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

Acronym: FAST

Important dates

Study start
2021
Primary completion
2022
Study completion
2029
First posted
Nov 6, 2020
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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