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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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). 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: No
View:

• 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

Locations
United States
Washington, D.c.
Children's National Medical Center
Recruiting
Washington
Contact Information
Primary
Emily McCracken
emccracken@childrensnational.org
202-476-4975
Backup
Marc DiSabella, DO
mdisabel@childrensnational.org
202-476-2120
Time Frame
Start Date: February 1, 2022
Estimated Completion Date: November 1, 2026
Participants
Target number of participants: 100
Treatments
Experimental: Treatment
Participants will receive a device and will be asked to treat headaches with it and report in the app the characteristics of the attacks at the beginning of the attack as well as at 2 hours after the treatment.
Authors
Sponsors
Collaborators: Theranica
Leads: Children's National Research Institute

This content was sourced from clinicaltrials.gov

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