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Nerivio Device for Treatment of New Daily Headache Persistence (NDHP)
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)
🗓️ Study Start (Actual) 1 February 2022
🗓️ Primary Completion (Estimated) 1 December 2025
✅ Study Completion (Estimated) 1 November 2026
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 12 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 March 2022
  • First Submitted that Met QC Criteria 31 March 2022
  • First Posted 4 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 August 2023
  • Last Update Posted 5 September 2023
  • Last Verified August 2023
I'm interested ...!!