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

Description

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). Pediatric patients with a diagnosis of new daily persistent headache are typically resistant to standard pharmacologic treatments and often experience systemic side effects related to medications; thus, REN offers the potential for an exciting new treatment option for patients with refractory headache disorders. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. Ultimately, the investigators hope to gain insights into the safety and efficacy of Nerivio™ for the acute treatment of NDPH in adolescents. The goal of this study is to demonstrate headache relief without unexpected device-related adverse effects

Conditions

New Daily Persistent Headache (NDPH)

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Study Overview

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Study Details

Study overview

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). Pediatric patients with a diagnosis of new daily persistent headache are typically resistant to standard pharmacologic treatments and often experience systemic side effects related to medications; thus, REN offers the potential for an exciting new treatment option for patients with refractory headache disorders. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. Ultimately, the investigators hope to gain insights into the safety and efficacy of Nerivio™ for the acute treatment of NDPH in adolescents. The goal of this study is to demonstrate headache relief without unexpected device-related adverse effects

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

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

Condition
New Daily Persistent Headache (NDPH)
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's National Research Institute,

Marc DiSabella, DO, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

2026-11-01