Managing Chronic Pain with Boston Scientific WaveWriter Alpha™ SCS Systems

This study is testing a device called the Boston Scientific WaveWriter Alpha™ SCS System, specifically using its Time Varied Pulse (TVP)-SCS settings, to help manage chronic pain. You might be able to join if you are 18 or older and have chronic pain in your back or legs that has lasted at least 6 months, especially if you have persistent spinal pain syndrome (PSPS) Type I or II. The researchers want to see how many people experience a significant reduction in their pain after 3 months of using the device. The current status of this study is unclear, but it plans to enroll about 70 participants.

Study design
This is an interventional study planning to enroll 70 participants. It is evaluating the effectiveness of a specific device setting for chronic pain.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 3 months after the device is activated.

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NCT07190807

Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control

Recruiting
NAAges 18+InterventionalTreatment
Boston Scientific Corporation
~70 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Boston Scientific WaveWriter Alpha™ SCS Systems

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Targeted Pain Responder Rate
Measured over 3 months post-activation
Chronic Pain
Intractable Pain
Low Back Pain
Chronic Low-back Pain
Chronic Leg Pain
Leg Pain
7 sites across 7 states
Colorado1
Florida1
Louisiana1
New York1
Pennsylvania1
South Carolina1
Texas1
  • Natalie M Bloom Lyons · STUDY_DIRECTOR · Boston Scientific Corporation

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Eligibility criteria

Inclusion

Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis.
Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months.
18 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 or EC approved informed consent form (ICF) provided in English.

Exclusion

Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).
Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
  • Targeted Pain Responder Rate3 months post-activation

    Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation