Nerivio Device for New Daily Persistent Headache

Recruiting at 1 trial location

Overseen By Emily McCracken

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Must be taking: Prophylaxis agents

Disqualifiers: Epilepsy, Congestive heart failure, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Nerivio device to determine if it can help teenagers with New Daily Persistent Headache (NDPH) feel better. The Nerivio device sends gentle electrical pulses to the upper arm, aiming to reduce headache pain without the side effects of regular medicines. Teens aged 12-17 who have experienced daily headaches for at least six months and have access to a smartphone might be suitable candidates. The researchers aim to determine if this device is safe and effective for treating headaches in these teens. As an unphased study, this trial offers a unique opportunity for teens to explore a new treatment option that could improve their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a stable dose of any preventive medications for at least three months before joining the study.

What prior data suggests that the Nerivio device is safe for adolescents with new daily persistent headache?

Research shows that the Nerivio device is safe for treating headaches. Previous studies found it effective for migraines in both adults and children. The FDA has approved the device, confirming its safety.

Most patients in these studies found the device easy to use. It involves no needles or pills, just a wearable device, making it a good choice for those who want to avoid medication side effects.

This study focuses on teenagers with new daily persistent headaches. The device's past use for migraines provides useful safety information. The researchers aim to determine its effectiveness for this specific type of headache without causing unexpected issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional medications for new daily persistent headache, which often involve oral drugs like NSAIDs or triptans, the Nerivio device offers a non-drug alternative. It uses remote electrical neuromodulation, a unique mechanism that targets nerve pathways to relieve pain. Researchers are excited because this wearable device provides a convenient, on-the-go treatment option that could reduce reliance on medications, potentially minimizing side effects and enhancing patient quality of life.

What evidence suggests that the Nerivio device is effective for New Daily Persistent Headache?

Research shows that the Nerivio device effectively treats migraines. Studies have found that it provides significant relief for people with chronic migraines. The device uses gentle electrical pulses on the upper arm to reduce headache pain. Strong evidence supports its safety and effectiveness over a year of use. In this trial, participants will use the Nerivio device to treat New Daily Persistent Headache. Although this trial focuses on adolescents with this condition, the device's success with migraines suggests it might be a promising option for these headaches as well. ^{1 3 6 7 8}

Who Is on the Research Team?

Marc DiSabella, DO

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 with New Daily Persistent Headache (NDPH) who haven't responded well to standard treatments. They must have had NDPH for at least six months, be on stable headache prevention medication for three months, and can operate a smartphone. It's not open to those with implanted devices like pacemakers, severe heart conditions, epilepsy, recent nerve blocks or Botox in the head/neck area, current participation in other trials, cognitive/motor issues affecting smartphone use, pregnancy/breastfeeding status or an arm circumference below 7.9 inches.

Inclusion Criteria

Parents/Guardians must be able and willing to provide written informed consent

I am willing and able to agree to participate in the study.

I have been on a stable dose of preventive medication for at least three months.

Exclusion Criteria

Current participation in any other clinical interventional study

I have epilepsy.

I have severe heart or brain blood vessel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Run-in

Participants complete a headache diary whenever they experience a new headache

4 weeks

1 visit (in-person)

Device Training

Participants receive the device and are trained on its use and intensity adjustment

1 week

1 visit (in-person)

Treatment

Participants use the device for headache treatment and report feedback through the app

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nerivio

Trial Overview The Nerivio device is being tested as a new treatment option for adolescent patients with NDPH. This non-drug therapy uses Remote Electrical Neuromodulation (REN) delivered through the upper arm to help relieve headaches by activating natural pain suppression pathways in the brain.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Participants will receive a device and will be asked to treat headaches with it and report in the app the characteristics of the attacks at the beginning of the attack as well as at 2 hours after the treatment.

Nerivio is already approved in European Union, United States for the following indications:

Approved in European Union as Nerivio for:

• Migraine treatment and prevention

Approved in United States as Nerivio for:

• Acute and preventive treatment of migraine with or without aura in individuals 8 years and older

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Theranica

Industry Sponsor

Trials

21

Recruited

41,700+

Published Research Related to This Trial

In a study of 42 adults with chronic migraine, the remote electrical neuromodulation (REN) device showed significant efficacy, with 73.7% of participants experiencing pain relief within 2 hours after treatment and 84.4% achieving sustained pain relief at 24 hours.

The REN device was well tolerated, with a low incidence of device-related adverse events (1.8%), suggesting it is a safe non-pharmacological option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. Nierenburg, H., Vieira, JR., Lev, N., et al.[2021]

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]

A 58-year-old patient with atrial fibrillation (AF) experienced recurrent episodes after multiple treatments, highlighting the challenges in detecting AF in real-world settings.

The use of a novel FDA-approved wireless ECG monitoring device allowed for timely detection of recurrent AF, demonstrating the potential of mobile health technology to improve patient care and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Recurrent Atrial Fibrillation Utilizing Novel Technology. Hickey, KT., Dizon, J., Frulla, A.[2022]

Patients with automatic defibrillators experience a complex daily life characterized by uncertainty and the need to adapt to significant changes, including renegotiating personal relationships and sexuality.

The study highlights the importance of integrating these patient experiences into nursing practice to improve post-discharge care, focusing on treatment management and the psychological impact of living with an automatic defibrillator.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The daily experience of the patient with an implantable cardioverter defibrillator]. Palacios-Ceña, D., Alonso-Blanco, C., Cachón-Pérez, JM., et al.[2010]

Nerivio® is a safe and effective noninvasive device for treating acute migraine attacks, supported by five clinical trials and two real-world studies, and is approved for use in individuals aged 12 and older.

The device is recommended as a tier 2 treatment option by the American Headache Society, highlighting its role as a viable alternative to traditional pharmacological treatments for migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerivio&#174; remote electrical neuromodulation for acute treatment of chronic migraine. Nierenburg, H., Stark-Inbar, A.[2022]

Implantable defibrillation devices are being enhanced to improve their technology and effectiveness, particularly in treating sustained ventricular tachyarrhythmias, with a focus on reducing defibrillation thresholds and simplifying lead systems.

New patient populations, including those with non-sustained ventricular tachycardia, long QT syndrome, and pediatric patients at risk for sudden death, are being identified for potential benefits from these devices, indicating a broader application of this therapy in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New generations of implantable pacemaker defibrillators for ventricular and atrial tachyarrhythmias. Saksena, S., Prakash, A., Madan, N., et al.[2009]

The use of a mobile health application for monitoring postdischarge patients significantly increased the rate of early interventions for hardware-related infections, from 20% in the control group to 83.3% in the group using the app.

Patients in the mobile app group had a much lower rate of infections at the time of intervention (8.3% vs. 60%) and a higher preservation rate of implantable pulse generators (75% vs. 16%), indicating the app's effectiveness in preventing severe complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application-Based Early Interventions of Hardware-Related Infection After Invasive Neuromodulation Prevent Implant Removal. Zhang, W., Li, J., Huang, S., et al.[2022]

The Res-Q Arrhythmia Control Device offers highly programmable features that allow for tailored therapies for various heart rhythm disorders, balancing efficacy and patient comfort with options like antitachycardia pacing and cardioversion.

While it shows promise as a competitive implantable cardioverter defibrillator (ICD) with a high implantation success rate, it currently lacks the ability to store electrograms, which could limit its utility in long-term monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description and evaluation of the Res-Q Arrhythmia Control Device. Miller, RE., Wilkoff, BL.[2019]

Nerivio, a wearable device that uses remote electrical neuromodulation, has been shown to be effective and safe for treating migraines, providing a non-addictive alternative to traditional medications.

The device is user-friendly, well-tolerated, and can be used without the need for additional medication, making it a valuable option for improving treatment adherence among migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of Nerivio for the acute and preventive treatment of episodic or chronic migraine in patients 12 years and older. Babaei, M., Rapoport, AM.[2023]

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]

In a study of 300 migraine sufferers, participants showed a low willingness to take prophylactic medications, even with a potential 50% reduction in headache frequency, primarily due to concerns about side effects.

Divalproex sodium was perceived as the least acceptable option due to its side effect profile, while gabapentin, propranolol, and topiramate were viewed more favorably, indicating that side effects significantly influence treatment choices among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a graphical risk tool to examine willingness to take migraine prophylactic medications. Turner, DP., Golding, AN., Houle, TT.[2022]

Citations

1. nerivio.com nerivio.com/clinical-trials/safety-and-efficacy-of-nerivio-for-the-preventive-treatment-of-migraine

Remote electrical neuromodulation for migraine prevention The findings of the study show that treatment with Nerivio every other day is significantly more effective than sham. There was a reduction of 3.97±0.41 Vs.

2. nerivio.com nerivio.com/clinical-trials/efficacy-and-safety-of-nerivio

Nerivio USA The findings of the study show that Nerivio is effective for the acute treatment of migraine in people with chronic migraine.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05310227

Nerivio Device for Treatment of New Daily Headache ... The purpose of this study is to assess the effect of the Nerivio device for treating New Daily persistent Headache (NDPH) in children. The Nerivio is a non- ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37855973/

One-Year Consistent Safety, Utilization, and Efficacy ... REN is a safe and well-tolerated acute migraine treatment, with stable efficacy and utilization over 1 year, making it an advantageous non-drug option.

5. nerivio.com nerivio.com/additional-research/chronic-migraine-comparison-to-acute-migraine-medications

A Post-Hoc Analysis Nerivio is an effective acute treatment for chronic migraine with non-inferior efficacy compared to current acute migraine therapies. Source: Grosberg B, Rabany ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04828707

Study Details | NCT04828707 | Assessment of Safety and ... Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days ...

7. nerivio.com nerivio.com/

#1 Prescribed Drug-Free Treatment For Migraine - Nerivio® FDA-authorized Nerivio REN wearable provides drug-free migraine relief or freedom for adults and kids 8+. Safe, effective, no pills, no needles.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8519197/

Safety and efficacy of remote electrical neuromodulation for ... The efficacy of REN was evaluated in patients with chronic migraine. Pain relief was achieved in 59.3% of participants and pain disappearance in 20.9% (2 hours ...