Spinal Cord Stimulation for Chronic Pain
(DYNAMO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 by current standard of care SCS.
Will I have to stop taking my current medications?
The trial requires that you keep your pain-related medications stable for 4 weeks before starting and during the study, meaning you shouldn't increase or add new pain medications during this time.
Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is generally considered safe for treating chronic pain, with common complications including lead migration, lead breakage, infection, and pain over the implant. It is a reversible surgical treatment, and while the exact mechanisms are not fully understood, it has been used for various conditions with success rates between 50-75% when performed by experienced professionals.12345
How is the WaveWriter Alpha Spinal Cord Stimulator treatment different from other treatments for chronic pain?
What data supports the effectiveness of the treatment Boston Scientific WaveWriter Alpha Spinal Cord Stimulator for chronic pain?
Research shows that spinal cord stimulation, including advanced systems like the WaveWriter Alpha, is effective for managing chronic pain. Studies highlight that multi-channel devices and new stimulation waveforms can provide significant pain relief and improve daily activities for many patients.1011121314
Who Is on the Research Team?
Ashwin Viswanathan, MD
Principal Investigator
Baylor College of Medicine
Are You a Good Fit for This Trial?
This trial is for adults over 22 with chronic pain in the trunk or limbs, lasting at least 6 months and scoring above a 6 on the pain scale. Participants must have tried multiple treatments without success, be stable on current medications, not had recent back surgery, and pass psychological screening. Women of childbearing age must use contraception. Exclusions include high surgical risk patients, those with cognitive impairments or certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive spinal cord stimulation using either time invariant pulse (TIP) or time variant pulse (TVP) stimulation patterns
Follow-up
Participants are monitored for therapy efficacy and safety through long-term follow-up, using multiple pain assessments and at-home digital data collection
What Are the Treatments Tested in This Trial?
Interventions
- Boston Scientific WaveWriter Alpha Spinal Cord Stimulator
Boston Scientific WaveWriter Alpha Spinal Cord Stimulator is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ashwin Viswanathan
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Boston Scientific Corporation
Industry Sponsor
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