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 — DEVICE
    Time 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

Locations (7)

FacilityCityStateZIPSite coordinators
Denver Back Pain SpecialistsGreenwoodColorado80111
Boston Scientific Clinical Research
855-213-9890
Orlando Health Neuroscience InstituteClermontFlorida24711
Boston Scientific Clinical Research
855-213-9890
Ochsner Clinic FoundationNew OrleansLouisiana70115
Boston Scientific Clinical Research
855-213-9890
Montefiore Medical CenterThe BronxNew York10461
Boston Scientific Clinical Research
855-213-9890
Fox Chase Pain ManagementTrevosePennsylvania19053
Boston Scientific Clinical Research
855-213-9890
PCPMG Clinical Research Unit, LLCGreenvilleSouth Carolina29601
Boston Scientific Clinical Research
855-213-9890
Institute of Precision Pain MedicineCorpus ChristiTexas78414
Boston Scientific Clinical Research
855-213-9890

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