What side effects are associated with this type of intervention?

The most common treatments for New Daily Persistent Headache (NDPH) similar to Remote Electrical Neuromodulation (REN) include transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS). Known side effects of these treatments are generally mild. For REN, side effects include a warm sensation, arm or hand numbness, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. TMS may cause mild discomfort at the stimulation site and, in rare cases, can theoretically trigger seizures in patients with epilepsy. Overall, these treatments are considered safe with no serious adverse events reported.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for treatments specifically targeting New Daily Persistent Headache (NDPH) using methods similar to the Remote Electrical Neuromodulation (REN) device. However, the REN device itself, which delivers transcutaneous electrical stimulation to induce conditioned pain modulation, is being studied as a potential treatment for NDPH. This suggests that while the REN device is under investigation, there may not yet be established FDA-approved treatments using this specific mechanism for NDPH.

What other types of research exist?

Promising novel alternatives to Remote Electrical Neuromodulation (REN) for New Daily Persistent Headache (NDPH) patients include: 1) Spinal Cord Stimulation (SCS), which has shown efficacy in various pain conditions including headaches, 2) Transcutaneous Trigeminal Nerve Stimulation (TNS), which has been effective in reducing headache days in migraine patients, and 3) High-frequency (10-kHz) Spinal Cord Stimulation, which has demonstrated significant pain relief in diabetic neuropathy and may be applicable to headache management. These alternatives offer potential benefits in terms of efficacy and safety for NDPH patients.

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Behavioural Intervention

Nerivio Device for New Daily Persistent Headache

N/A

Recruiting

Led By Marc DiSabella, DO

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants age 12-17 years old at the time of informed consent, inclusive.

Participants age 12-17 years old at the time of informed consent, inclusive

Must not have

Participants with epilepsy

Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and at 1 month after initiation of treatment with ren

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a wearable device that sends mild electrical pulses to help reduce headache pain in adolescents aged 12-17 with persistent headaches. The device is controlled by a smartphone app and works by triggering the brain's natural pain relief mechanisms. Data from several trials suggest that a device applying gentle electrical pulses can reduce headache pain.

Who is the study for?

This trial is for adolescents aged 12-17 with New Daily Persistent Headache (NDPH) who haven't responded well to standard treatments. They must have had NDPH for at least six months, be on stable headache prevention medication for three months, and can operate a smartphone. It's not open to those with implanted devices like pacemakers, severe heart conditions, epilepsy, recent nerve blocks or Botox in the head/neck area, current participation in other trials, cognitive/motor issues affecting smartphone use, pregnancy/breastfeeding status or an arm circumference below 7.9 inches.

What is being tested?

The Nerivio device is being tested as a new treatment option for adolescent patients with NDPH. This non-drug therapy uses Remote Electrical Neuromodulation (REN) delivered through the upper arm to help relieve headaches by activating natural pain suppression pathways in the brain.

What are the potential side effects?

While this study aims to confirm safety and effectiveness of Nerivio without unexpected adverse effects, potential side effects may include local discomfort where the device attaches or skin irritation from electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

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I am between 12 and 17 years old.

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I have had daily headaches for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have epilepsy.

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I have severe heart or brain blood vessel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and at 1 month after initiation of treatment with ren

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and at 1 month after initiation of treatment with ren

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and at 1 month after initiation of treatment with ren for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disappearance of associated symptoms at 2 hours post-treatment

Functional disability at 2 hours post-treatment

Improve of quality of life assessed by PedsMIDAS questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nerivio

2022

N/A

~1160

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for New Daily Persistent Headache (NDPH) that are similar to Remote Electrical Neuromodulation (REN) involve transcutaneous electrical stimulation techniques. These treatments work by inducing conditioned pain modulation (CPM) and activating descending endogenous analgesic mechanisms. CPM helps to reduce pain by triggering the body's natural pain-relief pathways, while the activation of descending analgesic mechanisms involves the release of neurotransmitters that inhibit pain signals. This is particularly important for NDPH patients, who often do not respond well to standard pharmacologic treatments and may experience significant side effects. By leveraging the body's own pain control systems, these neuromodulation techniques offer a promising alternative for managing persistent headaches without the adverse effects associated with medications.

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society.