Peripheral Nerve Stimulation for Headache

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: SPR Therapeutics, Inc.

Disqualifiers: Prior cervical surgery, Implanted device, Pregnant

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a device called the SPRINT® PNS System, which sends small electrical signals to nerves in the neck. It aims to help people who suffer from chronic or acute pain. The electrical signals work by blocking pain messages from reaching the brain, potentially reducing pain. This method has been used for decades to treat chronic pain and has seen significant advancements in technology and application in recent years.

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 data supports the effectiveness of the SPRINT Peripheral Nerve Stimulation System for treating headaches?

Peripheral nerve stimulation has been shown to help with chronic headaches related to occipital nerves and is considered useful for intractable headaches, although complications can occur. It is also emerging as an alternative for trigeminal pain, with some studies showing safety and effectiveness. ^{1 2 3 4 5}

Is peripheral nerve stimulation generally safe for humans?

Peripheral nerve stimulation (PNS) is generally considered safe, with most adverse events being minor. However, complications like skin erosion, infection, and lead migration have been reported, which can sometimes lead to stopping the treatment. ^{1 4 6 7 8}

How is the SPRINT Peripheral Nerve Stimulation treatment different from other headache treatments?

The SPRINT Peripheral Nerve Stimulation treatment is unique because it uses electrical stimulation to target peripheral nerves, which helps block pain signals, offering a non-drug alternative for chronic headaches. This approach is particularly useful for patients who have not found relief with less invasive treatments. ^{1 3 4 5 6}

Research Team

Eligibility Criteria

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.

It seems like there might be some information missing from your request. Can you provide more details or context so I can assist you better?

Exclusion Criteria

Pregnant

My diabetes is not well-managed.

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

Trial Timeline

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

Treatment Details

Interventions

• SPRINT Peripheral Nerve Stimulation (PNS) System (Other)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Pain Specialists of America - Cedar Park Cedar Park, TX

Center of Clinical Research Winston-Salem, NC

Pacific Research Institute Santa Rosa, CA

Institute of Precision Pain Medicine Corpus Christi, TX

More Trial Locations

Who Is Running the Clinical Trial?

SPR Therapeutics, Inc.

Lead Sponsor

Trials

14

Patients Recruited

850+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Outcome of Peripheral Nerve Stimulation for Chronic Headache and Complication Prevention. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Successful treatment of occipital neuralgia with implantable peripheral nerve stimulation in a pacemaker-dependent patient. [2021]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Using peripheral stimulation to reduce the pain of C2-mediated occipital headaches: a preliminary report. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety. [2023]