What is the Boston Scientific WaveWriter Alpha™ SCS System studying for chronic pain?

This study is evaluating the effectiveness of Time Varied Pulse (TVP)-SCS settings delivered by the Boston Scientific WaveWriter Alpha™ SCS System in managing chronic, intractable low back and/or leg pain. The research aims to gather real-world clinical outcomes to better understand pain relief using this device. The study is sponsored by Boston Scientific Corporation.

Who may be eligible for this chronic pain clinical trial?

Adults 18 years or older with a diagnosis of persistent spinal pain syndrome Type I or II and chronic pain in the trunk or limbs for at least 6 months may be eligible. Participants must be able to complete questionnaires in English and not be pregnant or planning pregnancy without contraception. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic pain clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07190807

Study of Boston Scientific WaveWriter Alpha SCS System Using Time Varied Pulse Settings to Treat Chronic Back and Leg Pain

Led by Boston Scientific Corporation · Updated on 2026-08-11

Participants Needed

Research Sites

78 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of the Time Varied Pulse TVP-SCS settings delivered through commercially approved Boston Scientific WaveWriter Alpha Spinal Cord Stimulation SCS Systems in patients experiencing chronic, intractable low back andor leg pain. This study aims to collect real-world clinical outcomes in individuals with persistent spinal pain syndrome or failed back surgery syndrome to better understand pain management using these devices. Participants will receive the TVP-SCS settings using the Boston Scientific WaveWriter Alpha SCS Systems according to local instructions for use. The study involves a single group of participants who will be treated with this device. The treatment is delivered through the device settings designed to adjust electrical stimulation parameters independently to manage chronic pain. Throughout the study, participants will be monitored up to three months post-activation to assess the primary outcome, which is the Targeted Pain Responder Rate. Participants will complete questionnaires and assessments in English to evaluate their pain levels and response to the treatment. Safety and effectiveness data will be collected during this period to understand the impact of the TVP-SCS settings on chronic pain management.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

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.

You will not qualify if you...

Any pain-related diagnosis, medical or psychological condition that 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 would impair ability to participate.
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 intending to participate in another drug or device clinical trial that may influence this study's data.

Research Team

Thanh Hoang

Diane Keesey

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Study of Boston Scientific WaveWriter Alpha SCS System Using Time Varied Pulse Settings to Treat Chronic Back and Leg Pain

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria