Status:
RECRUITING
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chronic Pain
Intractable Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 ad...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07190807
Start Date
November 7 2025
End Date
May 1 2029
Last Update
January 7 2026
Active Locations (5)
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1
Denver Back Pain Specialists
Greenwood, Colorado, United States, 80111
2
Montefiore Medical Center
The Bronx, New York, United States, 10461
3
Fox Chase Pain Management
Trevose, Pennsylvania, United States, 19053
4
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States, 29601