Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Part of paid clinical trials in Greenwood, Colorado.
- Sponsor
- Boston Scientific Corporation
- Study ID
- NCT07190807
- Status
- Recruiting
Conditions
- Chronic Leg Pain
- Chronic Low-back Pain
- Chronic Pain
- Intractable Pain
- Leg Pain
- Low Back Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Boston Scientific WaveWriter Alpha™ SCS Systems — DEVICETime Varied Pulse (TVP)-SCS settings
Study Details
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.
Key Dates
- Start date
- Nov 7, 2025
- Status verified
- Jun 2026
- Primary completion
- Nov 30, 2027
- Completion
- May 31, 2029
Study Design
- Enrollment
- 70 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Time Varied Pulse (TVP)-SCS settings
Primary Outcome Measure
Targeted Pain Responder Rate [ Time Frame: 3 months post-activation ]
Central Contacts
- Thanh Hoang855-213-9890
- Diane Keesey855-213-9890
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Denver Back Pain Specialists | Greenwood | Colorado | 80111 | |
| Orlando Health Neuroscience Institute | Clermont | Florida | 24711 | |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70115 | |
| Montefiore Medical Center | The Bronx | New York | 10461 | |
| Fox Chase Pain Management | Trevose | Pennsylvania | 19053 | |
| PCPMG Clinical Research Unit, LLC | Greenville | South Carolina | 29601 | |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | 78414 |
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