Nerivio Device for Treatment of New Daily Headache Persistence (NDHP)
Launched by CHILDREN'S NATIONAL RESEARCH INSTITUTE · Mar 31, 2022
Trial Information
Current as of July 09, 2025
Recruiting
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)
About Children's National Research Institute
Children's National Research Institute is a leading pediatric research organization dedicated to advancing the understanding and treatment of childhood diseases. As an integral part of Children's National Hospital, the institute focuses on innovative clinical trials and translational research that aim to improve health outcomes for children. Through collaborations with academic institutions, industry partners, and community organizations, the institute fosters a multidisciplinary approach to research, emphasizing safety, ethical standards, and the integration of cutting-edge technology in pediatric care. With a commitment to addressing the unique health challenges faced by children, Children's National Research Institute strives to translate research findings into effective therapies and interventions that enhance the quality of life for young patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
Patients applied
Trial Officials
Marc DiSabella, DO
Principal Investigator
Children's National Research Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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