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}

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.

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

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

References

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

Long-Term Clinical Outcome of Peripheral Nerve Stimulation for Chronic Headache and Complication Prevention. [2020] Subcutaneous peripheral nerve stimulation (PNS) has emerged as a useful tool in the treatment of intractable headaches. However, complications such as skin erosion, infection and lead migration have adversely affected clinical outcome, and occasionally led to treatment cessation.

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

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain. [2021] To conduct a systematic literature review of peripheral nerve stimulation (PNS) for pain.

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

Successful treatment of occipital neuralgia with implantable peripheral nerve stimulation in a pacemaker-dependent patient. [2021] Peripheral nerve stimulation has been used to treat patients with occipital nerve-related chronic headaches who have been unsuccessful with less invasive therapeutic approaches. Patients with pacemaker-dependent cardiac conduction abnormalities require unique consideration prior to the implantation of peripheral nerve stimulators because the placement of the devices may lead to failure of the systems secondary to electromagnetic interference or crosstalk between the devices.

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] Peripheral neurostimulation (PNS) for medically refractory trigeminal pain is an emerging alternative to traditional surgical approaches, with safety and efficacy demonstrated in several retrospective series and a prospective trial currently in progress. Many existing studies suffer from relatively small numbers and short or inconsistent follow-up, making balanced treatment assessment difficult.

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

Using peripheral stimulation to reduce the pain of C2-mediated occipital headaches: a preliminary report. [2015] Peripheral nerve stimulation (PNS) is an accepted treatment for neuropathic pain. Recent studies have focused on its potential for relieving headache pain.

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

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023] Peripheral nerve stimulation (PNS) refers to the technique of utilizing electrical stimulation of peripheral nerves to inhibit the transmission of pain signals. PNS is used to treat chronic intractable pain and post-surgical or post-traumatic pain alongside a variety of other pain conditions, including headaches, facial pain, pelvic and urogenital pain, chest wall pain, residual limb or phantom limb pain, and back pain.

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

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. [2022] In this study, we analyze device- and procedure-related adverse events (AEs) from a recent prospective, multicenter, double-blinded controlled study that utilized peripheral nerve stimulation (PNS) of occipital nerves for management of chronic migraine.

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

Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety. [2023] Peripheral nerve stimulation (PNS) was the first application of neuromodulation. Widespread application of PNS was limited by technical concerns. Recent advances now allow the percutaneous placement of leads with ultrasound or fluoroscopic guidance, while the transcutaneous powering of these leads removes the need for leads to cross major joints. This systematic review was written to assess the current status of high-quality evidence supporting the use of PNS for pain conditions treated by interventional pain physicians. The available literature on PNS, limited to conditions treated by interventional pain physicians, was reviewed and the quality assessed. Literature from 1966 to June 2021 was reviewed. The outcome measures were pain relief and functional improvement. One hundred and two studies were identified. Five randomized controlled trials (RCT) and four observational studies, all case series, met the inclusion criteria. One RCT was of high quality and four were of moderate quality; all four case series were of moderate quality. Three of the RCTs and all four case series evaluated peripheral nerve neuropathic pain. Based upon these studies, there is level II evidence supporting the use of PNS to treat refractory peripheral nerve injury. One moderate-quality RCT evaluated tibial nerve stimulation for pelvic pain, providing level III evidence for this indication. One moderate-quality RCT evaluated surgically placed cylindrical leads for cluster headaches, providing level III evidence for this indication. The evidence suggests that approximately two-thirds of patients with peripheral neuropathic pain will have at least 50% sustained pain relief. Adverse events from PNS are generally minor. A major advantage of PNS over spinal cord stimulation is the absence of any risk of central cord injury. The study was limited by the paucity of literature for some indications. No studies dealt with joint-related osteoarthritic pain.