Peripheral Nerve Stimulation for Headache

Not currently recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SPR Therapeutics, Inc.

Disqualifiers: Prior cervical surgery, Implanted device, Pregnant

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a device delivering small electrical pulses can relieve pain in individuals with headaches originating from neck issues. The treatment uses the SPRINT® PNS System, which stimulates nerves at the top of the neck. Individuals diagnosed with cervicogenic headache (headaches caused by neck problems) or occipital neuralgia (sharp pain at the base of the skull) might be suitable for this study. Those who have undergone neck or head surgery or have an implanted electronic device may not qualify. As an unphased trial, this study offers an opportunity to contribute to innovative research that could lead to new pain relief options.

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 trial coordinators or your doctor.

What prior data suggests that this device is safe for peripheral nerve stimulation?

Research shows that the SPRINT® Peripheral Nerve Stimulation (PNS) System has FDA approval for use up to 60 days to relieve chronic or acute pain, indicating it has undergone safety testing in people. The system treats various types of pain, such as post-surgical or injury-related pain.

The system reduces pain through electrical signals. While most people tolerate it well, it is crucial to note that it is not safe for use in MRI machines. The system is labeled "MR Unsafe," meaning it cannot be used during MRI scans. Overall, studies have shown that the treatment is safe for short-term use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional headache treatments that often include medication or invasive procedures, the SPRINT Peripheral Nerve Stimulation (PNS) System offers a unique, non-invasive approach. This system uses electrical stimulation through leads placed at the back of the neck, targeting the nerves associated with headaches directly. Researchers are excited because this method could provide relief without the side effects commonly associated with medications, offering a new avenue of hope for headache sufferers looking for effective, drug-free options.

What evidence suggests that the SPRINT PNS System is effective for headache relief?

Research has shown that the SPRINT Peripheral Nerve Stimulation (PNS) System, used by participants in this trial, can greatly reduce headache pain. One study found that 90% of participants experienced at least a 30% decrease in their pain. Another study reported that most people using the PNS system for 60 days noticed less pain and fewer disruptions to their daily activities. Real-world data from over 6,100 patients also supports these findings, demonstrating significant pain relief with the SPRINT PNS System. This device is approved to provide relief for up to 60 days for both long-term and short-term pain. These results suggest that the SPRINT PNS System could help manage headache pain by sending small electrical signals to specific nerves. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with specific head pain conditions like cervicogenic headache or occipital neuralgia. It's not suitable for those with uncontrolled diabetes, pregnant women, people who've had prior neck or back-of-the-head surgery, or those with certain implanted electronic devices.

Inclusion Criteria

I have been diagnosed with cervicogenic headache or occipital neuralgia.

Exclusion Criteria

Pregnant

My diabetes is not well-managed.

I have had surgery on my neck or the base of my skull.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive electrical stimulation using the SPRINT® PNS System for up to 60 days

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• SPRINT Peripheral Nerve Stimulation (PNS) System

Trial Overview The study tests the SPRINT Peripheral Nerve Stimulation System to see if it can relieve head pain by delivering electrical stimulation to nerves in the upper neck. The device is FDA-cleared for up to 60 days of use for chronic or acute pain relief.

How Is the Trial Designed?

Group I: Peripheral Nerve Stimulation Experimental Treatment 1 Intervention

All study subjects will have up to 2 leads placed in the back of their neck, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

SPRINT Peripheral Nerve Stimulation (PNS) System is already approved in United States for the following indications:

Approved in United States as SPRINT PNS System for:

• Symptomatic relief of chronic, intractable pain
• Post-surgical and post-traumatic acute pain
• Symptomatic relief of post-traumatic pain
• Symptomatic relief of post-operative pain

Who Is Running the Clinical Trial?

SPR Therapeutics, Inc.

Lead Sponsor

Trials

14

Recruited

850+

Published Research Related to This Trial

In a 12-week pilot study involving 11 patients, peripheral nerve stimulation (PNS) significantly reduced occipital headache pain, with patients reporting a 64% decrease in pain scores on the Short-Form McGill Pain Questionnaire and a 67% decrease on the Visual Analog Scale.

Most patients experienced fewer headaches and reduced medication use, indicating that PNS not only alleviates pain but also improves overall quality of life, despite two minor adverse events related to the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using peripheral stimulation to reduce the pain of C2-mediated occipital headaches: a preliminary report. Melvin, EA., Jordan, FR., Weiner, RL., et al.[2015]

Implanting the pulse generator (IPG) closer to the lead location, such as in the infraclavicular region, significantly reduces the incidence of adverse events (AEs) related to peripheral nerve stimulation (PNS) for chronic migraine management, indicating a safer surgical approach.

Increased experience of the implanter, measured by the number of prior PNS implants performed, is associated with a lower rate of stimulation- and hardware-related AEs, suggesting that skill and precision improve with practice, leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Sharan, A., Huh, B., Narouze, S., et al.[2022]

Peripheral nerve stimulation (PNS) shows level II evidence for effectively treating refractory peripheral nerve injury, with about two-thirds of patients experiencing at least 50% sustained pain relief, based on a systematic review of 102 studies.

PNS has a safety advantage over spinal cord stimulation, as it carries no risk of central cord injury, and adverse events are generally minor, making it a promising option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety. Helm, S., Shirsat, N., Calodney, A., et al.[2023]

Peripheral nerve stimulation (PNS) is an effective technique for managing various types of chronic and acute pain by using electrical stimulation to inhibit pain signal transmission in both central and peripheral pathways.

PNS works by inhibiting specific pain fibers in the central nervous system and downregulating inflammatory mediators and neurotransmitters involved in pain signaling, making it a versatile option for treating conditions like post-surgical pain, headaches, and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

A systematic review of 14 randomized controlled trials (RCTs) found moderate to strong evidence supporting the effectiveness of peripheral nerve stimulation (PNS) for treating various types of pain, including headaches, back pain, and pelvic pain.

The study highlights the need for more prospective trials to better identify which patient populations and specific pain conditions would benefit most from PNS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain. Deer, TR., Esposito, MF., McRoberts, WP., et al.[2021]

An 86-year-old woman with chronic cervicogenic headaches and a pacemaker successfully received a peripheral nerve stimulator, remaining pain-free for one year post-implantation, indicating potential efficacy for patients with similar conditions.

Precautions, such as placing the nerve stimulator leads away from the pacemaker, can help minimize the risk of device interference, suggesting that simultaneous implantation of these devices may be safe with proper monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of occipital neuralgia with implantable peripheral nerve stimulation in a pacemaker-dependent patient. Chaiban, G., Tolba, R., Eissa, H., et al.[2021]

Peripheral neurostimulation (PNS) for trigeminal pain showed a significant mean pain reduction of 52.3% in 80% of patients after at least 14 months of follow-up, indicating its efficacy as a treatment option.

The procedure was found to be safe and well-tolerated, with no cases of erosion or migration of the implanted systems, although there were high rates of infection and revision, suggesting careful patient selection is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation for Refractory Trigeminal Pain: Recent Single-Institution Case Series With Long-Term Follow-Up and Review of the Literature. Bina, RW., Palsma, RS., Weinand, ME., et al.[2022]

In a study of 24 patients with chronic headaches over 9 years, subcutaneous peripheral nerve stimulation (PNS) significantly reduced headache intensity, duration, and frequency, with a mean total pain index dropping from 516 to 74.8 after treatment.

The modified surgical technique used in the implantation of PNS minimized complications, as there were no acute post-operative infections, and a high percentage of patients reported excellent to good satisfaction with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Outcome of Peripheral Nerve Stimulation for Chronic Headache and Complication Prevention. Zhou, L., Ashkenazi, A., Smith, JW., et al.[2020]

Citations

1. sprpainrelief.com sprpainrelief.com/press-releases/sprint-pns-first-publication-multicenter-monarch-study

SPRINT® PNS meets primary endpoint of reduction in head ... In the prospective study, 90 percent (18/20) of participants met the primary endpoint with clinically significant (≥30 percent) reductions in ...

2. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/full/10.1111/head.14948

A multicenter, prospective, single‐arm study of 60‐day ... Most participants reported significant reductions in pain and/or pain interference following 60-day PNS targeting the occipital nerves. Outcomes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11801347/

Real-world long-term outcomes of peripheral nerve stimulation Patients report clinically meaningful long-term pain relief after receiving PNS through both 60-day and permanent implant systems.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05491915

NCT05491915 | The MONARCH Case Series Study ... The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves at the ...

5. relievepaincenter.com relievepaincenter.com/real-world-data-from-over-6100-patients-corroborates-significant-pain-reduction-from-prior-prospective-studies-for-patients-treated-with-sprint-pns/

Real-World Data from Over 6100 Patients Corroborates ... The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic ...

6. sprpainrelief.com sprpainrelief.com/hcp/sprint-pns-system/safety-information

Safety Information - SPR The SPRINT PNS System is MR Unsafe. – All MRI procedures, no matter the anatomic site, are contraindicated for patients with SPRINT PNS System.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11234914/

A review of prospective studies regarding percutaneous ... Percutaneous peripheral nerve stimulation is a US FDA-cleared treatment that can be implanted for up to 60 days. Data from prospective clinical studies have ...

8. mayo.edu mayo.edu/research/clinical-trials/cls-20542848

SPRINT® Peripheral Nerve Stimulation (PNS) System to ... The purpose of this study is to collect additional data on the safety and effiectiveness of the SPRINT PNS System for the treatment of head pain.

9. neurosurgeryone.com neurosurgeryone.com/treatment/sprint-peripheral-nerve-stimulation/

Sprint Peripheral Nerve Stimulator | Back Pain The device is FDA-cleared for the treatment of acute and chronic pain, including post-operative and post-traumatic pain. Real-world data from a survey of 252 ...