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

NCT07190807 | Recruiting FDA Device

• 1 other identifier: A4116
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief Summary

Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.

Conditions

Chronic Pain; Low Back Pain; Chronic Low-back Pain; Chronic Leg Pain; Leg Pain; Intractable Pain

Keywords

Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Targeted Pain Responder Rate

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

  3 months post-activation

Study Arms (1)

Time Varied Pulse (TVP)-SCS settings

EXPERIMENTAL

Device: Boston Scientific WaveWriter Alpha™ SCS Systems

Interventions

Boston Scientific WaveWriter Alpha™ SCS Systems DEVICE

Time Varied Pulse (TVP)-SCS settings

Time Varied Pulse (TVP)-SCS settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

Denver Back Pain Specialists

Greenwood, Colorado, 80111, United States

RECRUITING

Orlando Health Neuroscience Institute

Clermont, Florida, 24711, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70115, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Fox Chase Pain Management

Trevose, Pennsylvania, 19053, United States

RECRUITING

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

RECRUITING

Institute of Precision Pain Medicine

Corpus Christi, Texas, 78414, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain, Intractable; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Natalie M Bloom Lyons

  Boston Scientific Corporation

  STUDY DIRECTOR

Central Study Contacts

Thanh Hoang

CONTACT

855-213-9890; BSNClinicalTrials@bsci.com

Diane Keesey

CONTACT

855-213-9890; BSNClinicalTrials@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (7)