NCT07190807 Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
| NCT ID | NCT07190807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-11-07 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.
Contact & Investigator
Natalie M Bloom Lyons
STUDY DIRECTOR
Boston Scientific Corporation
Frequently Asked Questions
Who can join the NCT07190807 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07190807 currently recruiting?
Yes, NCT07190807 is actively recruiting participants. Contact the research team at BSNClinicalTrials@bsci.com for enrollment information.
Where is the NCT07190807 trial being conducted?
This trial is being conducted at Greenwood, United States, Clermont, United States, New Orleans, United States, The Bronx, United States and 3 additional locations.
Who is sponsoring the NCT07190807 clinical trial?
NCT07190807 is sponsored by Boston Scientific Corporation. The principal investigator is Natalie M Bloom Lyons at Boston Scientific Corporation. The trial plans to enroll 70 participants.
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