Status:
WITHDRAWN
Nerivio Device for Treatment of New Daily Headache Persistence (NDHP)
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Theranica
Conditions:
New Daily Persistent Headache (NDPH)
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
The goal of this study is to examine the effects of the Remote Electrical Neuromodulation (REN) device on adolescents ages 12-17 who have been diagnosed with New Daily Persistent Headache (NDPH). Pedi...
Detailed Description
This is a research study to evaluate a new non-invasive drug-free acute treatment of headache in adolescents aged 12-17 years old. Participants are being asked to take part in this study because they ...
Eligibility Criteria
Inclusion
- Participants age 12-17 years old at the time of informed consent, inclusive.
- Participants have at least a 6-month history of headaches that meet the diagnostic criteria for New Daily Persistent Headache (NDPH)
- Participants who are on stable dosing of prophylaxis agents for at least three months.
- Participants have personal access to a smartphone (24/7)
- Participants must be able and willing to comply with the protocol
- Parents/Guardians must be able and willing to provide written informed consent
- Participants must be able and willing to provide informed assent
Exclusion
- Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with epilepsy.
- 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.
- Current participation in any other clinical interventional study
- Participants without basic cognitive and motor skills required for operating a smartphone.
- Pregnant or breastfeeding females
- Participants who have previous experience with the device
- Participants with arm circumference below 7.9 inches (20 cm)
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05310227
Start Date
February 1 2022
End Date
September 11 2023
Last Update
July 24 2025
Active Locations (1)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010