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

NCT05310227 | Withdrawn DMC FDA Device

• 1 other identifier: Pro00016835
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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). 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)

Keywords

New Daily Persistent Headache (NDPH); Nerivio Device

Outcome Measures

Primary Outcomes (5)

• Pain relief at 2 hours post-treatment

  The proportion of participants achieving pain relief at 2 hours post-treatment in the test treatment, with no use of rescue/abortive medication (Pain relief defined as a change from severe to moderate, mild or none, moderate to mild or none, or mild to none)

  2 hours post-treatment

• Within-patient consistency

  The repeatability of headache change, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks

  Before and at 1 Month after initiation of treatment with REN

• Disappearance of associated symptoms at 2 hours post-treatment

  Disappearance of nausea, photophobia and phonophobia at 2 hours post- treatment

  2 hours post-treatment

• Functional disability at 2 hours post-treatment

  The proportion of participants achieving a change of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication

  2 hours post-treatment

• Improve of quality of life assessed by PedsMIDAS questionnaire

  Change in average headache disability as measured by PedsMIDAS before and at 1 month after initiation of treatment with REN.

  Before and at 1 Month after initiation of treatment with REN

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Device: Nerivio

Interventions

Nerivio DEVICE

The device is a wireless wearable battery-operated stimulation unit controlled by a dedicated smartphone application. Treatments with Nerivio™ are self-administered by the user at the onset of a headache

Treatment

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's National Research Institute: lead
• Theranica: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Study Officials

• Marc DiSabella, DO

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The device is a wireless wearable battery-operated stimulation unit controlled by a dedicated smartphone application. Treatments with Nerivio™ are self-administered by the user at the onset of a headache. The Nerivio™ includes several main components: * A pair of electrodes covered with hydrogel and a removeable protective film * An electronic circuitry and a battery * A software that includes firmware and a software application for mobile platforms * An armband to secure the attachment of the device and enable a discreet treatment

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 4, 2022
• Study Start: February 1, 2022
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

US (1)