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SCS System

FAST Spinal Cord Stimulation for Chronic Pain (FAST Trial)

N/A
Waitlist Available
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
22 years of age or older when written informed consent is obtained
Key
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-activation
Awards & highlights

FAST Trial Summary

This trial is to study a new, fast-acting pain relief therapy called FAST-SCS in comparison to other SCS therapy options.

Who is the study for?
This trial is for adults over 22 with chronic pain, specifically neuropathic pain in the trunk or limbs that's lasted at least 6 months. Participants must be able to read and understand English, complete questionnaires, and have signed an informed consent form. It excludes those with conditions that could affect study results, significant cognitive impairments, pregnant or breastfeeding individuals not using contraception, or anyone in another conflicting clinical trial.Check my eligibility
What is being tested?
The effectiveness of a new therapy called FAST-SCS (fast-acting paresthesia-free) is being tested using the Boston Scientific WaveWriter SCS System on patients with chronic pain. The study will also look into additional SCS therapy options provided by this system.See study design
What are the potential side effects?
While specific side effects are not listed here, typical side effects from similar spinal cord stimulation systems can include discomfort at the implant site, tingling sensations due to electrical pulses (paresthesia), infection risk from surgery, and potential equipment malfunction.

FAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 22 years old or older.
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It seems like the criterion is incomplete. Could you provide more details or context so I can assist you better?
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I have had chronic pain in my back or limbs for at least 6 months, with back pain being the most severe.
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I have had chronic pain in my back or limbs for at least 6 months, with back pain being worse than leg pain.
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I am 22 years old or older.
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I have had chronic pain in my back or limbs for at least 6 months, with back pain being as bad or worse than leg pain.
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I have signed an informed consent form in English.

FAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-activation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Targeted Pain Responder Rate

FAST Trial Design

1Treatment groups
Experimental Treatment
Group I: WaveWriter SettingsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
715 Previous Clinical Trials
934,313 Total Patients Enrolled
32 Trials studying Chronic Pain
64,992 Patients Enrolled for Chronic Pain
Natalie Bloom LyonsStudy DirectorBoston Scientific Corporation
15 Previous Clinical Trials
24,591 Total Patients Enrolled
4 Trials studying Chronic Pain
10,306 Patients Enrolled for Chronic Pain
Roshini JainStudy DirectorBoston Scientific Corporation
29 Previous Clinical Trials
26,098 Total Patients Enrolled
12 Trials studying Chronic Pain
11,331 Patients Enrolled for Chronic Pain

Media Library

Boston Scientific WaveWriter SCS System (SCS System) Clinical Trial Eligibility Overview. Trial Name: NCT04618471 — N/A
Chronic Pain Research Study Groups: WaveWriter Settings
Chronic Pain Clinical Trial 2023: Boston Scientific WaveWriter SCS System Highlights & Side Effects. Trial Name: NCT04618471 — N/A
Boston Scientific WaveWriter SCS System (SCS System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04618471 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in this clinical trial?

"To complete the research, 66 eligible subjects are necessary. The Boston Scientific Corporation is sponsoring this trial and it will be carried out at multiple locations such as University of Chicago Hospital in Illinois and Willis-Knighton River Cities Clinical Research Center in Louisiana."

Answered by AI

How many medical centers are currently conducting this investigation?

"The University of Chicago Hospital, Willis-Knighton River Cities Clinical Research Center and Denver Back pain Specialists are merely three out of the thirteen medical centres participating in this clinical trial. These clinics are located in Illinois, Louisiana and Colorado respectively."

Answered by AI

Is there a current opportunity to sign up for this trial?

"As per clinicaltrials.gov, this research initiative is currently enrolling participants. The investigation was initially posted on February 10th 2021 and the most recent update happened in November 7th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
How old are they?
18 - 65
What site did they apply to?
Willis-Knighton River Cities Clinical Research Center
Pacific Sports and Spine, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~43 spots leftby Mar 2025