FAST Spinal Cord Stimulation for Chronic Pain
(FAST Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Boston Scientific WaveWriter SCS System for chronic pain?
Spinal cord stimulation (SCS) has been shown to be effective in managing chronic pain conditions like failed back surgery syndrome and complex regional pain syndrome, providing pain relief and improving quality of life. The technology, including programmable implanted devices, has advanced significantly, making it a reliable option for patients with chronic pain.12345
Is spinal cord stimulation generally safe for humans?
How does the Boston Scientific WaveWriter SCS System treatment differ from other treatments for chronic pain?
The Boston Scientific WaveWriter SCS System is unique because it offers a customizable spinal cord stimulation (SCS) approach, allowing for individual current control across multiple channels, which can be adjusted based on patient feedback. This system is designed to provide significant pain relief without the systemic side effects or addiction risks associated with some other chronic pain treatments.311121314
What is the purpose of this trial?
This trial is testing a new pain relief treatment that acts quickly and doesn't cause tingling. It targets patients with chronic pain who don't respond well to regular treatments. The treatment uses a device that sends electrical signals to the spine to block pain.
Research Team
Natalie Bloom Lyons
Principal Investigator
Boston Scientific Corporation
Eligibility Criteria
This trial is for adults over 22 with chronic pain, specifically neuropathic pain in the trunk or limbs that's lasted at least 6 months. Participants must be able to read and understand English, complete questionnaires, and have signed an informed consent form. It excludes those with conditions that could affect study results, significant cognitive impairments, pregnant or breastfeeding individuals not using contraception, or anyone in another conflicting clinical trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FAST-SCS and other SCS therapies using WaveWriter systems
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Boston Scientific WaveWriter SCS System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead 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