BridgeMD
New treatment option for Chronic Pain
Official title Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
ClinicalTrials.gov ID: NCT07190807
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g...
- Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the...
- A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate...
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Greenwood, Colorado, United States
- Clermont, Florida, United States
- New Orleans, Louisiana, United States
- The Bronx, New York, United States
- Trevose, Pennsylvania, United States
- Greenville, South Carolina, United States
- Corpus Christi, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greenwood, Colorado, United States; Clermont, Florida, United States; New Orleans, Louisiana, United States; The Bronx, New York, United States; Trevose, Pennsylvania, United States; Greenville, South Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.