177 Participants Needed

FAST Spinal Cord Stimulation for Chronic Pain

(FAST Trial)

Recruiting at 13 trial locations
AL
DK
Overseen ByDiane Keesey
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Scientific Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered a safe treatment for chronic pain conditions, with studies showing it is effective and has a good safety profile. However, specific risks associated with certain procedures, like paddle lead removal, are not well defined in the literature.12345

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.678910

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.811121314

Who Is on the Research Team?

NB

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Corporation

Are You a Good Fit for This Trial?

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

I have had chronic pain in my back or limbs for at least 6 months, with back pain being the most severe.
I am 22 years old or older.
I have had chronic pain in my back or limbs for at least 6 months, with back pain being as bad or worse than leg pain.
See 2 more

Exclusion Criteria

I am not breastfeeding, planning to become pregnant, or not using birth control.
You have any medical or psychological conditions that could make it difficult to accurately report how you are feeling during the study.
Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FAST-SCS and other SCS therapies using WaveWriter 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

  • Boston Scientific WaveWriter SCS System
Trial Overview The effectiveness of a new therapy called FAST-SCS (fast-acting paresthesia-free) is being tested using the Boston Scientific WaveWriter SCS System on patients with chronic pain. The study will also look into additional SCS therapy options provided by this system.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: WaveWriter SettingsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

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 profile image

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

Published Research Related to This Trial

Burst spinal cord stimulation (SCS) provides greater pain relief compared to traditional tonic stimulation, as shown in multiple blinded, sham-controlled, randomized trials.
Patients prefer burst SCS due to its effectiveness in alleviating pain without causing uncomfortable sensations (paresthesias) and its positive impact on both physical and emotional aspects of pain.
Burst Spinal Cord Stimulation: A Clinical Review.Kirketeig, T., Schultheis, C., Zuidema, X., et al.[2020]
Spinal cord stimulation (SCS) is a low-risk, reversible technique that effectively manages chronic, intractable pain when patients are carefully selected, as shown by multicenter prospective studies.
Recent advancements in electrode placement and programmable electronics have enhanced the implementation of SCS, and ongoing innovations are expected to further improve its efficacy.
Spinal cord stimulation for failed back surgery syndrome and other disorders.Nicholson, CL., Korfias, S., Jenkins, A.[2019]
Spinal cord stimulation has become a low-morbidity technique for managing chronic pain, with recent advancements allowing for easier implantation and adjustment of the system in patients.
A new computerized system for patient interaction has been clinically tested in 25 patients, proving to be safe and effective, and allows for quicker adjustments to the stimulator compared to traditional methods, enhancing the overall management of pain relief.
Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment.North, RB., Fowler, K., Nigrin, DJ., et al.[2004]

Citations

Burst Spinal Cord Stimulation: A Clinical Review. [2020]
Spinal cord stimulation for failed back surgery syndrome and other disorders. [2019]
Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment. [2004]
Spinal cord stimulation for chronic pain. [2020]
Factors associated with the success of trial spinal cord stimulation in patients with chronic pain from failed back surgery syndrome. [2021]
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. [2022]
High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. [2022]
Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. [2022]
Spinal cord stimulation in deafferentation pain. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
A new spinal cord stimulation system effectively relieves chronic, intractable pain: a multicenter prospective clinical study. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Current and future trends in spinal cord stimulation for chronic pain. [2022]
Efficacy of 10 kHz spinal cord stimulation in complex regional pain syndrome: A retrospective analysis. [2023]
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