Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Boston Scientific Corporation · NCT07190807
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 70
- US sites recruiting
- 7
- Study start
- November 7, 2025
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Boston Scientific WaveWriter Alpha™ SCS Systems
Conditions: Chronic Pain; Intractable Pain; Low Back Pain; Chronic Low-back Pain; Chronic Leg Pain; Leg Pain
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Denver Back Pain Specialists
Greenwood, CO 80111
Site contact: Boston Scientific Clinical Research · 855-213-9890 · BSNClinicalTrials@bsci.com
Orlando Health Neuroscience Institute
Clermont, FL 24711
Site contact: Boston Scientific Clinical Research · 855-213-9890 · BSNClinicalTrials@bsci.com
Ochsner Clinic Foundation
New Orleans, LA 70115
Site contact: Boston Scientific Clinical Research · 855-213-9890 · BSNClinicalTrials@bsci.com
Montefiore Medical Center
The Bronx, NY 10461
Site contact: Boston Scientific Clinical Research · 855-213-9890 · BSNClinicalTrials@bsci.com
Fox Chase Pain Management
Trevose, PA 19053
Site contact: Boston Scientific Clinical Research · 855-213-9890 · BSNClinicalTrials@bsci.com
PCPMG Clinical Research Unit, LLC
Greenville, SC 29601
Site contact: Boston Scientific Clinical Research · 855-213-9890 · BSNClinicalTrials@bsci.com
Institute of Precision Pain Medicine
Corpus Christi, TX 78414
Site contact: Boston Scientific Clinical Research · 855-213-9890 · BSNClinicalTrials@bsci.com
Study contacts (from the official record)
- Thanh Hoang · 855-213-9890 · BSNClinicalTrials@bsci.com
- Diane Keesey · 855-213-9890 · BSNClinicalTrials@bsci.com
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