What is the mechanism of action of this treatment?

Peripheral Nerve Stimulation (PNS) and similar neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS) and Spinal Cord Stimulation (SCS), work by delivering electrical impulses to specific nerves or regions of the nervous system. These impulses modulate pain signals, either by inhibiting the transmission of pain or by altering the perception of pain in the brain. For Cervicogenic Headache patients, these treatments are significant because they target the underlying neural pathways responsible for pain, offering potential relief when traditional pharmacologic treatments are ineffective or contraindicated. By directly addressing the neural mechanisms of pain, PNS and similar therapies can provide targeted, non-invasive pain management options.

What side effects are associated with this type of intervention?

Peripheral nerve stimulation (PNS) for cervicogenic headache, such as the SPRINT® PNS System, generally has mild side effects. These can include sensations of warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in the area of stimulation. Serious adverse events are rare. Other neuromodulation techniques like transcranial magnetic stimulation (TMS) and spinal cord stimulation (SCS) also report mild side effects, with TMS potentially triggering seizures in patients with epilepsy and SCS having risks of lead migration and infection.

What prior FDA approvals exist?

The SPRINT® PNS System, which uses peripheral nerve stimulation for pain relief, is FDA-cleared for up to 60 days of use for chronic or acute pain. While specific FDA approvals for cervicogenic headache treatments are not detailed, similar neuromodulation techniques like transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS) have been approved for migraine treatment. These devices, such as the TMS device available in the U.S. and U.K., and the nVNS device, offer potential alternatives for managing headache-related pain through electrical stimulation.

What other types of research exist?

Promising, novel alternatives to the SPRINT® PNS System for cervicogenic headache patients in 2024 include high-frequency spinal cord stimulation (SCS), burst SCS, and closed-loop SCS. These advanced neuromodulation techniques have shown efficacy in managing chronic pain and may offer effective treatment options for cervicogenic headaches.

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Other

Peripheral Nerve Stimulation for Headache

N/A

Recruiting

Research Sponsored by SPR Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON)

Key

Must not have

Uncontrolled Diabetes mellitus Type I or II

Prior cervical or cranial occipital surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8-weeks after sot, 3-months after sot, 6-months after sot, 9-months after sot, 12-months after sot

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, skin irritation from adhesive pads, and possible nerve injury due to electrical stimulation. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cervicogenic headache or occipital neuralgia.

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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

You may be eligible for the trial if you check “No” for criteria below:

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My diabetes is not well-managed.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8-weeks after sot, 3-months after sot, 6-months after sot, 9-months after sot, 12-months after sot

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8-weeks after sot, 3-months after sot, 6-months after sot, 9-months after sot, 12-months after sot

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8-weeks after sot, 3-months after sot, 6-months after sot, 9-months after sot, 12-months after sot for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in average pain and/or reduction in pain interference.

Study-Related Adverse Events (AEs)

Secondary study objectives

Reduction in average pain intensity

Reduction in pain interference

Reduction in pain medication usage

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Peripheral Nerve StimulationExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SPRINT Peripheral Nerve Stimulation (PNS) System

2017

N/A

~280

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral Nerve Stimulation (PNS) and similar neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS) and Spinal Cord Stimulation (SCS), work by delivering electrical impulses to specific nerves or regions of the nervous system. These impulses modulate pain signals, either by inhibiting the transmission of pain or by altering the perception of pain in the brain. For Cervicogenic Headache patients, these treatments are significant because they target the underlying neural pathways responsible for pain, offering potential relief when traditional pharmacologic treatments are ineffective or contraindicated. By directly addressing the neural mechanisms of pain, PNS and similar therapies can provide targeted, non-invasive pain management options.