Spinal Cord Stimulation for Chronic Pain

(MED Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Nevro Corp

Disqualifiers: Psychiatric disorders, Neurological diseases, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called MED HF10™ Spinal Cord Stimulation for individuals with persistent back and/or leg pain unresponsive to other treatments. Researchers aim to identify the optimal settings for the device already implanted in patients, focusing on effectiveness with minimal stimulation. Participants must have had a Nevro SCS device implanted for at least three months, experience chronic back pain, and have achieved at least 30% pain relief in the targeted area using their device. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires that you stay on your stable chronic pain medications without changing the dose until the study is completed or you withdraw from it.

What is the safety track record for MED HF10™ Spinal Cord Stimulation?

Research has shown that the MED HF10™ Spinal Cord Stimulation (SCS) is generally safe for people. In one study, over 70% of patients experienced effective and lasting pain relief with this treatment. Another review found that HF10 SCS uses a special type of electrical signal, proven safe in both animal and human studies.

Various studies over time have examined the safety of HF10 SCS. One analysis demonstrated that the treatment is well-tolerated in the long run. As this trial is in a later phase, extensive safety information is available. This indicates that MED HF10™ SCS has been tested in many studies, confirming its general safety for people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike traditional treatments for chronic pain that often rely on medication or physical therapy, the MED HF10™ Spinal Cord Stimulation offers a unique approach by using pulse dosing to target pain signals in the spinal cord directly. Most treatments tend to mask pain without addressing the neural pathways involved. Researchers are excited about MED HF10™ because it works by delivering high-frequency electrical pulses to the spinal cord, potentially providing significant pain relief without the side effects commonly associated with pain medications. This method could offer more consistent and long-lasting relief for chronic pain sufferers.

What is the effectiveness track record for MED HF10™ Spinal Cord Stimulation in treating chronic pain?

Research has shown that the MED HF10™ Spinal Cord Stimulation (SCS) effectively treats chronic pain. Studies indicate that over 70% of patients using HF-SCS experienced lasting pain relief. In one study, after 24 months, 60% of patients reported their back pain reduced by more than half, and 71% noted similar reductions in leg pain. Additionally, patients observed a significant drop in pain intensity and a reduced need for opioids. These findings highlight the effectiveness of HF10 SCS in providing long-term relief for back and leg pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Mayank Gupta, MD

Principal Investigator

Neuroscience Research Center

Are You a Good Fit for This Trial?

This trial is for individuals with chronic, intractable back and/or leg pain (sciatica) who already have Nevro Spinal Cord Stimulation (SCS) devices implanted. Specific eligibility details are not provided, but typically participants must meet certain health criteria to be included.

Inclusion Criteria

Be compliant in using the patient programmer and recharger as determined by the Investigator

I have long-lasting back pain that doesn’t go away, with or without leg pain.

I have been on stable pain medication for at least 28 days and can keep the dose the same during the study.

Exclusion Criteria

I have a progressive neurological disease.

I had surgery or a procedure for back or leg pain, not including Senza HF10, in the last month.

Have a condition currently requiring or likely to require diathermy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulse dosing adjustments to find the lowest preferred pulse dose setting

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MED HF10™ Spinal Cord Stimulation

Trial Overview The study explores the effectiveness of different program settings on the MED HF10™ SCS device in managing chronic pain. It's a single-center, non-randomized exploratory study focusing on patients' preferred pulse dose settings and their response to them during an observational period.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 1 Intervention

Pulse Dosing

Who Is Running the Clinical Trial?

Nevro Corp

Lead Sponsor

Trials

11

Recruited

1,800+

Published Research Related to This Trial

HF10 spinal cord stimulation (SCS) therapy provides effective pain relief for chronic back and leg pain without causing paresthesia, making it a unique option for patients.

Clinical trials and reports indicate that HF10 SCS is safe and effective, even for patients who have not found relief with other neuromodulation therapies, suggesting it could be an important early treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

10-kHz High-Frequency SCS Therapy: A Clinical Summary. Russo, M., Van Buyten, JP.[2022]

In a study of 18 patients with chronic pain who did not respond to conventional spinal cord stimulation (SCS), 61% were successfully treated with 10-kHz high-frequency (HF10) stimulation, showing significant pain relief in both low-back and limb pain after 12 months.

The study suggests that HF10-SCS can effectively rescue patients from conventional SCS failure without needing additional surgery, although factors like obesity and gender may influence treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation as rescue therapy for chronic pain patients with failure of conventional spinal cord stimulation. Cordero Tous, N., Sánchez Corral, C., Ortiz García, IM., et al.[2021]

In a study of 256 patients with chronic intractable pain, 73% reported successful trials with high frequency spinal cord stimulation (HF10 therapy), particularly those with back and leg pain, showing its effectiveness as a treatment option.

Patients experienced a sustained mean pain reduction of 50% up to 6 months post-implant, with significant improvements in functional outcomes, making HF10 a promising alternative to traditional spinal cord stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience. Russo, M., Verrills, P., Mitchell, B., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6414485/

A multicenter real‐world review of 10 kHz SCS outcomes for ... Sustained and effective pain relief was experienced by >70% of our HF‐SCS‐treated patients, consistent with the findings of a previously ...

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

Spinal Cord Stimulation vs Medical Management for ... Analysis results suggest statistical superiority of conventional and novel SCS therapies over CMM in 5 of the 6 outcomes evaluated at 6-month ...

3. academic.oup.com academic.oup.com/painmedicine/article/15/3/347/1844840

24-Month Results of a Prospective Multicenter Study | Pain ... After 24 months of HF10 SCS, 60% of patients reported reductions from baseline back pain of greater than 50%, and 71% of patients reported reductions in leg ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772594424000220

A single-center real-world review of 10 kHz high-frequency ... Our results demonstrate a >70% long-term efficacy for HF-SCS treatment. This is consistent with data reported from the two most comprehensive HF-SCS studies to ...

5. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/31891

10 kHz Spinal Cord Stimulation for the Treatment of Non ... The average pain intensity, on the VAS pain intensity scale, decreased from 79 ± 12 mm to 10 ± 12 mm and the use of opioids decreased from 18 ...

6. academic.oup.com academic.oup.com/painmedicine/article/16/5/934/2460708

10-kHz High-Frequency SCS Therapy: A Clinical Summary HF10 SCS uses a charge-balanced stimulation waveform that has been shown to be safe in both animal and human studies. Data from a multicenter, prospective ...

7. hca.wa.gov hca.wa.gov/assets/program/SCS-final-evidence-report-October-2023.pdf

Spinal Cord Stimulation Rereview: Final Evidence Report This technology assessment report is based on research conducted by a contracted technology assessment center, with updates as contracted by ...

8. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-016-0657-2

Safety and efficacy of cervical 10 kHz spinal cord stimulation ... We report the results of a retrospective analysis assessing the long-term safety, tolerability and efficacy of HF10 SCS in a group of patients ...