WaveWriter Alpha SCS for Chronic Pain

(MOSAIC Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Cognitive impairment, Pregnancy, Untreated depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method for managing chronic pain using a device that sends varying electrical pulses to the spine, known as Time Variant Pulse-SCS. The goal is to determine if these pulses can alleviate constant, hard-to-treat back or leg pain. It targets individuals who have experienced chronic pain for at least six months, including those who haven't found relief after back surgery or have ongoing back issues. As an unphased trial, this study offers patients the chance to explore innovative pain management solutions that may provide relief where other treatments have failed.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for treating chronic pain?

Research has shown that spinal cord stimulation (SCS) therapies, such as the Time Variant Pulse (TVP)-SCS under study, are generally well-tolerated by individuals with chronic pain. In one study on dynamic SCS, participants reported fewer side effects compared to traditional methods. Additionally, a review of studies found that SCS treatments for chronic back and leg pain were safe, with few serious side effects.

Real-world data from 7,000 patients using similar SCS systems have demonstrated that these treatments are usually safe. Most side effects were mild and temporary, such as discomfort at the implant site. This suggests that TVP-SCS could be a safe option for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Time Variant Pulse Spinal Cord Stimulation (TVP-SCS) for chronic pain because it offers a new twist on spinal cord stimulation technology. Traditional spinal cord stimulators use constant electrical pulses to relieve pain, but TVP-SCS introduces varying pulse timings, which may more effectively mimic natural nerve signals, potentially leading to better pain relief. This innovative approach could offer hope for patients whose chronic pain hasn't responded well to existing treatments like opioids or conventional spinal cord stimulators.

What evidence suggests that this device is effective for chronic pain?

Research shows that spinal cord stimulation (SCS) using time-dynamic pulses (TDPs) can significantly reduce chronic pain. Studies have found that TDPs, used in a method called time variant pulse (TVP)-SCS, may provide longer-lasting pain relief compared to traditional methods. While both TDPs and regular stimulation ease pain, TDPs maintain effectiveness for a longer period before pain returns. Real-world data from thousands of patients support these findings, suggesting that TVP-SCS, which participants in this trial will receive, could be a promising option for individuals with chronic low back and leg pain. ^{1 2 4 6 7}

Who Is on the Research Team?

Natalie M Bloom Lyons

Principal Investigator

Boston Scientific Corporation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with persistent spinal pain syndrome (PSPS) Type I or II, including those with chronic back or leg pain lasting at least 6 months. Participants must be able to read and complete English questionnaires and have signed an approved consent form.

Inclusion Criteria

I can read and fill out questionnaires in English by myself.

I have chronic back pain not relieved by surgery or without having had surgery.

I have had chronic pain in my trunk or limbs for over 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive time variant pulse (TVP)-SCS treatment using Boston Scientific SCS Systems

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time Variant Pulse (TVP)-SCS

Trial Overview The study tests the effectiveness of time variant pulse (TVP)-SCS using Boston Scientific WaveWriter Alpha™ SCS Systems in managing chronic, intractable low back and/or leg pain.

How Is the Trial Designed?

Group I: Time Varied Pulse (TVP)-SCS settings Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014672/

Spinal cord stimulation using time-dynamic pulses ... Although TDPs and tonic stimulation comparably mitigated allodynia, TDPs exhibited slower rate of wash-out, suggesting longer-lasting analgesic effects.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05968664

Study Details | NCT05968664 | Novel Stimulation Patterns ... The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved ...

3. nature.com nature.com/articles/s41598-020-77212-w

Time-dynamic pulse modulation of spinal cord stimulation ... We tested the hypothesis that modulated SCS using novel time-dynamic pulses (TDPs) leads to improved analgesia and compared the effects of SCS using ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023004704

Real World Characterization of Chronic Pain, Success ... We present real-world data from 7,000 patients who underwent SCSeval while utilizing a mobile digital health platform for education, feedback, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10867969/

Exploratory evaluation of spinal cord stimulation with dynamic ... We conducted an acute exploratory study to evaluate the effects of SCS using time-dynamic pulses as compared to time-static (conventional tonic) stimulation ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ... This systematic review and network meta-analysis found that SCS therapies for treatment of chronic pain in back and/or lower extremities were associated with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6703564/

Spinal cord stimulation in chronic pain - PubMed Central - NIH Collectively, the emerging evidence shows P-SCS and PF-SCS may differentially correct dysfunctional neural networks ubiquitous in the chronic pain patient.