AVPI Device for Migraine

(NC06 Trial)

Recruiting at 2 trial locations

Overseen By Melissa Walker, MS RAC FRAPS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nocira, LLC

Must be taking: Prophylactic migraine medication

Must not be taking: Opioids, Barbiturates

Disqualifiers: Pregnancy, Hypertension, Ear disorders, others

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

Compensation: Varies

Number of Visits: 1

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the Nocira AVPI Device, a gadget for quick migraine relief, on people who suffer from migraines. The device aims to reduce or stop migraine pain through a specific type of treatment.

Will I have to stop taking my current medications?

If you are on preventive migraine medication, you must have been on a stable dose for at least 3 months before joining the study and continue with the same dose during the study. If you use acute migraine medication, you should not have taken it via IV infusion within two weeks before screening, and you should not use it within 24 hours before each treatment.

What data supports the effectiveness of the AVPI Device treatment for migraines?

The AVPI Device may be similar to vagus nerve stimulation (VNS), which has shown effectiveness in reducing seizures in epilepsy patients. VNS has been used for many years and has helped improve the quality of life for patients with drug-resistant epilepsy, suggesting potential benefits for other conditions like migraines. ^{1 2 3 4 5}

Is the AVPI Device generally safe for use in humans?

The AVPI Device, similar to other noninvasive neuromodulation devices like Nerivio™, has been shown to have a high safety profile with very few mild adverse events reported in studies. In a real-world analysis, only 0.48% of users reported device-related adverse events, most of which were mild, indicating it is generally safe for human use. ^{6 7 8 9 10}

How does the AVPI Device treatment for migraine differ from other treatments?

The AVPI Device treatment for migraine is unique because it involves compressing the temporal arteries on the scalp to block or reduce migraine pain, which is different from typical drug treatments. This method is non-invasive and does not involve medication, offering an alternative for those who may not tolerate or prefer to avoid drugs. ^{8 9 11 12 13}

Eligibility Criteria

Adults aged 18-75 with a history of migraines, experiencing 2-10 attacks per month. Participants must not be in other trials, should have stable migraine medication for 3 months if applicable, and need internet access via mobile device. Excluded are pregnant individuals, those unable to distinguish migraine types or follow instructions, with certain ear conditions or significant medical issues that could affect the study.

Inclusion Criteria

Subjects must have wireless access to the internet via mobile computing or smartphone device for audio and/or video contacts

Subjects on prophylactic migraine medication must have been on a stable dose for at least 3 months prior to study entry and must remain on the same therapy with stable dosing during the study

Willingness, ability, and commitment to participate in baseline and follow-up evaluations without concurrent participation in another clinical trial

Exclusion Criteria

Failure to meet any of the inclusion criteria

Unwilling or unable to provide informed consent

Pregnancy or intent to become pregnant over the course of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase I - Clinic Treatment

Initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator

45 days

Multiple visits (in-person)

Phase II - Home Treatment

Further evaluation of the device when used in the home (non-clinical) environment

45 days

Home-based treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AVPI Device

Trial Overview The AVPI Device is being tested for its effectiveness in treating acute migraines. The trial has two phases: an initial screening (Phase I) where the device's operation is checked under supervision and a home-use evaluation (Phase II). It's a double-blind study meaning neither participants nor researchers know who gets the real treatment versus a sham (fake) one.

Participant Groups

Group I: Group 2 Home Treatment Experimental Treatment 1 Intervention

Randomized active or sham for first home treatment followed by open-label treatments in the home environment.

Group II: Group 1b Clinic & Home Treatment Experimental Treatment 1 Intervention

Open-label, active treatment for subjects treated in prior clinical trials for this device, followed by open-label treatments in the home environment.

Group III: Group 1a Clinic Treatment Experimental Treatment 1 Intervention

Randomized, active or sham in-clinic treatment during a migraine, followed by open-label treatments in the home environment.

Who Is Running the Clinical Trial?

Nocira, LLC

Lead Sponsor

Trials

2

Recruited

160+

Findings from Research

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]

Remote electrical neuromodulation (REN) is an effective and safe treatment for acute migraine, with 66.5% of patients achieving pain relief in at least half of their treatments, based on data from 23,151 treatments across 2,514 patients.

The device was primarily used as a standalone treatment (66.5% of cases), and adverse events were rare, with only 0.48% of users reporting device-related issues, mostly mild in nature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. Ailani, J., Rabany, L., Tamir, S., et al.[2022]

Nerivio™, a noninvasive remote electrical neuromodulation device, has shown high efficacy and a favorable safety profile in treating acute migraine, as supported by two randomized trials.

The device works by applying electrical stimulation to peripheral nerves in the upper arm, offering a novel mechanism of action that may reduce the risk of medication overuse headaches and improve the quality of life for migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the Nerivio™ for acute migraine treatment: overview of its efficacy and safety. Rapoport, AM., Lin, T.[2020]

References

1. Israel pubmed.ncbi.nlm.nih.gov

[Vagus nerve stimulation for partial seizures]. [2006]

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

Vagal nerve stimulation in children. [2019]

3. France pubmed.ncbi.nlm.nih.gov

[Vagus nerve stimulation for the treatment of refractory epilepsy]. [2008]

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

Vagus nerve stimulation (VNS) therapy update. [2019]

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

Preliminary experience with a new system for vagus nerve stimulation for the treatment of refractory focal onset seizures. [2013]

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

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

7. Italy pubmed.ncbi.nlm.nih.gov

Is the Migraid device an asset in the non-pharmacologic treatment of migraine? [2007]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Device profile of the Nerivio™ for acute migraine treatment: overview of its efficacy and safety. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Tolerability of sumatriptan: clinical trials and post-marketing experience. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study. [2022]

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

Treatment of migraine attacks by compression of temporal superficial arteries using a device. [2009]

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

Compression of superficial temporal arteries by a handmade device: a simple way to block or attenuate migraine attacks in children and adolescents. [2009]