Using the Nerivio Device to Treat New Daily Persistent Headaches in Teens

A Prospective, Single Arm, Open Label Study of the Safety and Efficacy of Nerivio™ for the Acute Treatment of New Daily Headache Persistence (NDHP) in Adolescents

This study is testing if the Nerivio device can help teens aged 12-17 with New Daily Persistent Headaches feel better when they use it during their headaches.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Children's National Research Institute (other)
• Locations: 1 site (Washington, District of Columbia)
• Trial ID: NCT05310227 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Nerivio device, a non-invasive Remote Electrical Neuromodulation (REN) treatment, for adolescents aged 12-17 diagnosed with New Daily Persistent Headache (NDPH). Participants will self-administer the device during headache episodes and report their experiences through a smartphone app. The study aims to assess both the safety and efficacy of this innovative treatment option, particularly for patients who have not responded well to traditional medications. Over an 8-week period, participants will attend three clinic visits to monitor their progress and headache characteristics.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-17 with a history of New Daily Persistent Headache lasting at least six months.

Not a fit: Patients with implanted electrical devices, severe cardiac conditions, epilepsy, or those who have received certain prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a drug-free option for adolescents suffering from persistent headaches, reducing reliance on medications and their side effects.

How similar studies have performed: While the Nerivio device has been approved for migraine treatment, this specific application for New Daily Persistent Headache in adolescents is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Participants age 12-17 years old at the time of informed consent, inclusive.
2. Participants have at least a 6-month history of headaches that meet the diagnostic criteria for New Daily Persistent Headache (NDPH)
3. Participants who are on stable dosing of prophylaxis agents for at least three months.
4. Participants have personal access to a smartphone (24/7)
5. Participants must be able and willing to comply with the protocol
6. Parents/Guardians must be able and willing to provide written informed consent
7. Participants must be able and willing to provide informed assent

Exclusion Criteria:

1. Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
2. Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
3. Participants with epilepsy.
4. Participants who have undergone nerve block (occipital or other) in the head or neck, or treatment with onabotulinum toxin A (Botox) to the head and/or neck in the prior four months.
5. Current participation in any other clinical interventional study
6. Participants without basic cognitive and motor skills required for operating a smartphone.
7. Pregnant or breastfeeding females
8. Participants who have previous experience with the device
9. Participants with arm circumference below 7.9 inches (20 cm)

Where this trial is running

Washington, District of Columbia

• Children's National Medical Center — Washington, District of Columbia, United States (RECRUITING)

Study contacts

• Principal investigator: Marc DiSabella, DO — Children's National Research Institute
• Study coordinator: Emily McCracken

Conditions: New Daily Persistent Headache, Nerivio Device