WITHDRAWN

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-02-01
Study Completion:2023-09-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT05310227

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.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Participants age 12-17 years old at the time of informed consent, inclusive.
  2. 2. Participants have at least a 6-month history of headaches that meet the diagnostic criteria for New Daily Persistent Headache (NDPH)
  3. 3. Participants who are on stable dosing of prophylaxis agents for at least three months.
  4. 4. Participants have personal access to a smartphone (24/7)
  5. 5. Participants must be able and willing to comply with the protocol
  6. 6. Parents/Guardians must be able and willing to provide written informed consent
  7. 7. Participants must be able and willing to provide informed assent
  1. 1. Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
  2. 2. Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
  3. 3. Participants with epilepsy.
  4. 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. 5. Current participation in any other clinical interventional study
  6. 6. Participants without basic cognitive and motor skills required for operating a smartphone.
  7. 7. Pregnant or breastfeeding females
  8. 8. Participants who have previous experience with the device
  9. 9. Participants with arm circumference below 7.9 inches (20 cm)

Contacts and Locations

Principal Investigator

Marc DiSabella, DO
PRINCIPAL_INVESTIGATOR
Children's National Research Institute

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Children's National Research Institute

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

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

Study Start Date2022-02-01
Study Completion Date2023-09-11

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2023-09-11

Terms related to this study

Keywords Provided by Researchers

  • New Daily Persistent Headache (NDPH)
  • Nerivio Device

Additional Relevant MeSH Terms

  • New Daily Persistent Headache (NDPH)