25 Participants Needed

Spinal Cord Stimulation for Chronic Pain

(MED Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Nevro Corp
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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 data supports the effectiveness of the treatment MED HF10™ Spinal Cord Stimulation for chronic pain?

Research shows that the HF10 Spinal Cord Stimulation treatment is effective in reducing chronic pain in the back and legs, with benefits lasting up to 24 months. It has also been successful as a backup option for patients who did not find relief with other spinal cord stimulation methods.12345

Is spinal cord stimulation at 10 kHz safe for humans?

Research on 10 kHz spinal cord stimulation (HF10 SCS) shows it is generally safe for humans, with studies reporting long-term safety and tolerability in treating chronic pain and headaches.13467

How is the MED HF10™ Spinal Cord Stimulation treatment different from other treatments for chronic pain?

The MED HF10™ Spinal Cord Stimulation treatment is unique because it uses high-frequency (10 kHz) stimulation to relieve pain without causing paresthesia (a tingling sensation), which is common in other spinal cord stimulation therapies. This treatment is also effective for patients who did not benefit from conventional spinal cord stimulation.12345

What is the purpose of this trial?

This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.

Research Team

MG

Mayank Gupta, MD

Principal Investigator

Neuroscience Research Center

Eligibility Criteria

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.
See 5 more

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
See 13 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Pulse Dosing

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nevro Corp

Lead Sponsor

Trials
11
Recruited
1,800+

Findings from Research

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

References

Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. [2022]
High-frequency spinal cord stimulation as rescue therapy for chronic pain patients with failure of conventional spinal cord stimulation. [2021]
High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience. [2019]
10-kHz High-Frequency SCS Therapy: A Clinical Summary. [2022]
High-frequency spinal cord stimulation at 10 kHz for widespread pain: a retrospective survey of outcomes from combined cervical and thoracic electrode placements. [2019]
Safety and efficacy of cervical 10 kHz spinal cord stimulation in chronic refractory primary headaches: a retrospective case series. [2018]
Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. [2022]
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