Time‑variant pulse spinal cord stimulation for chronic low back and leg pain
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)
This trial will test whether time‑variant pulse spinal cord stimulation using the Boston Scientific WaveWriter Alpha system can reduce chronic low back or leg pain in adults who have not found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 7 sites (Greenwood, Colorado and 6 other locations) |
| Trial ID | NCT07190807 on ClinicalTrials.gov |
What this trial studies
This interventional study uses commercially approved Boston Scientific WaveWriter Alpha spinal cord stimulation systems, delivered per local instructions for use, to apply a time‑variant pulse (TVP) waveform in patients with chronic trunk and/or limb pain. Eligible adults have persistent spinal pain syndrome (PSPS) Type I or II or non‑surgical refractory back pain and symptoms for at least six months. The study will collect real‑world clinical outcomes and patient‑reported measures at participating sites to characterize pain response to TVP‑SCS. Enrollment and follow‑up involve in‑clinic visits at designated U.S. centers and completion of English questionnaires.
Who should consider this trial
Good fit: Adults (18+) with chronic trunk or limb pain for at least six months, diagnosed with PSPS Type I or II (including failed back surgery), who can read English and provide informed consent are the intended candidates.
Not a fit: Patients with other pain diagnoses likely to confound outcomes (for example vascular or neurogenic claudication, acute herniated disc, malignancy, untreated major depression), significant cognitive impairment, or active injury claims are unlikely to receive benefit or may be excluded.
Why it matters
Potential benefit: If successful, this approach could provide better or more durable pain relief and improved daily function for people with chronic low back and/or leg pain.
How similar studies have performed: Spinal cord stimulation is an established therapy for chronic low back and leg pain and prior studies of varied SCS waveforms have shown benefit, though time‑variant pulse (TVP) approaches are relatively newer and less extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Greenwood, Colorado and 6 other locations
- Denver Back Pain Specialists — Greenwood, Colorado, United States (Recruiting)
- Orlando Health Neuroscience Institute — Clermont, Florida, United States (Recruiting)
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Fox Chase Pain Management — Trevose, Pennsylvania, United States (Recruiting)
- PCPMG Clinical Research Unit, LLC — Greenville, South Carolina, United States (Recruiting)
- Institute of Precision Pain Medicine — Corpus Christi, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Thanh Hoang
- Email: BSNClinicalTrials@bsci.com
- Phone: 855-213-9890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.