Nerivio Device for New Daily Persistent Headache

Overseen by Marc DiSabella, DO

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's National Research Institute

Must be taking: Prophylaxis agents

Disqualifiers: Epilepsy, Congestive heart failure, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a wearable device that sends mild electrical pulses to help reduce headache pain in adolescents aged 12-17 with persistent headaches. The device is controlled by a smartphone app and works by triggering the brain's natural pain relief mechanisms. Data from several trials suggest that a device applying gentle electrical pulses can reduce headache pain.

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 data supports the effectiveness of the Nerivio treatment for New Daily Persistent Headache?

Nerivio, a wearable device using remote electrical neuromodulation, has been shown to be effective and safe for treating migraines, as supported by multiple clinical trials and real-world studies. While specific data for New Daily Persistent Headache is not available, its success in treating migraines suggests potential effectiveness for similar headache conditions. ^{1 2 3 4 5}

Is the Nerivio device safe for use in humans?

The Nerivio device has been shown to be safe for treating migraines, with studies reporting a high safety profile and very few mild adverse events. In a real-world analysis, only 0.48% of users reported any device-related adverse events, and none were severe. ^{1 2 3 5 6}

How is the Nerivio treatment different from other treatments for new daily persistent headache?

Nerivio is unique because it is a wearable device that uses remote electrical neuromodulation (stimulation of nerves) to treat headaches, unlike traditional medications that are taken orally or injected. This non-invasive approach offers an alternative for those who prefer not to use drugs or have not found relief with standard treatments. ^{7 8 9 10 11}

Research Team

Marc DiSabella, DO

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Nerivio (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Michelle Riley-Brown

Children's National Research Institute

Chief Executive Officer since 2023

MHA from Washington University School of Medicine in St. Louis, Bachelor's degree from Tulane University

Catherine Bollard

Children's National Research Institute

Chief Medical Officer

MBChB, MD

Theranica

Industry Sponsor

Trials

21

Recruited

41,700+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Nerivio&#174; remote electrical neuromodulation for acute treatment of chronic migraine. [2022]

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

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

3. England 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. [2023]

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

Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Using a graphical risk tool to examine willingness to take migraine prophylactic medications. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[The daily experience of the patient with an implantable cardioverter defibrillator]. [2010]

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

Detection of Recurrent Atrial Fibrillation Utilizing Novel Technology. [2022]

9. France pubmed.ncbi.nlm.nih.gov

New generations of implantable pacemaker defibrillators for ventricular and atrial tachyarrhythmias. [2009]

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

Application-Based Early Interventions of Hardware-Related Infection After Invasive Neuromodulation Prevent Implant Removal. [2022]

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

Description and evaluation of the Res-Q Arrhythmia Control Device. [2019]