What side effects are associated with this type of intervention?

Common treatments for chronic pain, such as spinal cord stimulation (SCS), can have side effects including infection at the implant site, lead migration, and hardware malfunction. Patients may also experience pain at the implant site, and in some cases, neurological complications. Other neuromodulation techniques, like transcutaneous electrical nerve stimulation (TENS), may cause skin irritation or discomfort at the electrode sites. Overall, while these treatments can be effective, they are not without risks and should be discussed thoroughly with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of chronic pain, including Spinal Cord Stimulation (SCS). SCS involves the use of electrical impulses to relieve pain by modifying pain signal transmission in the spinal cord. The FAST-SCS study focuses on a paresthesia-free form of SCS, which aims to provide pain relief without the tingling sensation typically associated with traditional SCS. Other related FDA-approved treatments include transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical nerve stimulation (PENS), which also use electrical impulses to manage pain. These therapies offer alternative options for patients with chronic pain, particularly those who do not respond to conventional treatments.

What other types of research exist?

Promising novel alternatives to FAST-SCS for chronic pain patients include: 1) Remote electrical neuromodulation, which has shown significant pain relief in migraine patients and is approved in the US. 2) Transcranial magnetic stimulation (TMS), effective for migraine and potentially useful for other pain conditions, available in the US and UK. 3) Noninvasive vagus nerve stimulation (nVNS), beneficial for episodic migraine and under investigation for other pain conditions. These therapies offer non-invasive options with demonstrated efficacy and safety profiles.

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SCS System

FAST Spinal Cord Stimulation for Chronic Pain (FAST Trial)

N/A

Waitlist Available

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.

Must not have

Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-activation

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical side effects from similar spinal cord stimulation systems can include discomfort at the implant site, tingling sensations due to electrical pulses (paresthesia), infection risk from surgery, and potential equipment malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It seems like the criterion is incomplete. Could you provide more details or context so I can assist you better?

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I have had chronic pain in my back or limbs for at least 6 months, with back pain being the most severe.

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I am 22 years old or older.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not breastfeeding, planning to become pregnant, or not using birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-activation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-activation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-activation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Targeted Pain Responder Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: WaveWriter SettingsExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Spinal Cord Stimulation (SCS) works by delivering electrical impulses to the spinal cord to modulate pain signals before they reach the brain, effectively inhibiting pain transmission and activating inhibitory pathways. The FAST-SCS, a newer approach, aims to provide pain relief without the tingling sensation (paresthesia) associated with traditional SCS. This is significant for chronic pain patients as it offers a more comfortable and potentially more effective pain management option, enhancing their quality of life without the discomfort of paresthesia.

Italian multicentric study on pain treatment with epidural spinal cord stimulation.Spinal Cord Stimulation for Neuropathic Pain: Current Trends and Future Applications.Spinal cord stimulation modulates descending pain inhibition and temporal summation of pricking pain in patients with neuropathic pain.