Nerivio Device for Treatment of New Daily Headache Persistence (NDHP)

Launched by CHILDREN'S NATIONAL RESEARCH INSTITUTE · Mar 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the Nerivio Device, a new treatment for adolescents aged 12 to 17 who suffer from New Daily Persistent Headache (NDPH). NDPH is a condition where headaches occur daily and can be difficult to treat with traditional medications. The Nerivio Device uses a technique called Remote Electrical Neuromodulation (REN), which sends electrical signals to the upper arm. These signals are believed to help reduce headache pain by activating the body's natural pain relief system. The main goal of the trial is to see if this device can provide effective headache relief without causing any unexpected side effects.

To participate in this study, adolescents must be between 12 and 17 years old and have had headaches for at least six months that meet the criteria for NDPH. They should also be stable on their current headache prevention medications for at least three months and have access to a smartphone. It's important that both the participants and their parents or guardians are willing to give consent to join the study. Participants will be monitored for safety and effectiveness while using the Nerivio Device, and they will have the chance to share their experiences throughout the trial. This study is currently recruiting participants, and it's an exciting opportunity for those looking for new options to manage their headaches.

Gender

ALL

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)