Recruiting

TVP-SCSManaging Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control

Sponsor:

Boston Scientific Corporation

Code:

NCT07190807

Conditions

Chronic Pain

Intractable Pain

Low Back Pain

Chronic Low-back Pain

Chronic Leg Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Boston Scientific WaveWriter Alpha™ SCS Systems

Study Details

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 addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.

Conditions

Chronic Pain

Intractable Pain

Low Back Pain

Chronic Low-back Pain

Chronic Leg Pain

Study ID

NCT07190807

Start date

Nov 7, 2025

Status verified date

Sep, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Time Varied Pulse (TVP)-SCS settings

Interventions

Boston Scientific WaveWriter Alpha™ SCS Systems

Time Varied Pulse (TVP)-SCS settings

Primary outcome measure

Targeted Pain Responder Rate [ Time Frame: 3 months post-activation ]

Central Contacts and Locations

Central contacts

Thanh Hoang

855-213-9890 BSNClinicalTrials@bsci.com

Diane Keesey

855-213-9890 BSNClinicalTrials@bsci.com

Locations

Denver Back Pain Specialists

Recruiting

Greenwood, Colorado, United States, 80111

Contacts