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Neuromodulation Device

Neuromodulation Therapy for Migraine in Children and Adolescents

Phase 3

Waitlist Available

Led By Serena L Orr, MD, MSc, FRCPC

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Patients aged 8-18 years visiting the Alberta Children's Hospital Emergency Department (ED) with an acute attack of migraine as per criteria B-E of the International Classification of Headache Disorders-3 criteria (ICHD-3)

Headache attacks lasting at least 2 hours (untreated or unsuccessfully treated)

Must not have

Allergy or contraindication to metoclopramide, ketorolac, or non-steroidal anti-inflammatories

Current secondary headache

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study)

Awards & highlights

Pivotal Trial

Summary

This trial will study whether a remote electrical neuromodulation device is a feasible and acceptable treatment option for children and adolescents visiting the emergency department with acute migraine attacks.

Who is the study for?

This trial is for children and adolescents aged 8-18 who experience acute migraine attacks, understand English, and have an upper arm circumference of at least 20 cm. They can't participate if they're pregnant, lactating, have severe heart or brain conditions, allergies to certain meds, recent head trauma, fever at triage, abnormal skin on arms or implanted electrical devices.

What is being tested?

The study tests a new Remote Electrical Neuromodulation Device against standard IV treatments (metoclopramide/ketorolac) in the emergency department setting. If initial treatment fails during the trial phase, participants will switch to the other treatment method.

What are the potential side effects?

Standard IV treatments may cause significant side effects like pain from catheter use and reactions to neuroleptics. The neuromodulation device's side effects are not detailed but could include discomfort or skin irritation where it's applied.

Eligibility Criteria

Inclusion Criteria

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

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I am between 8-18 years old and have a migraine, as diagnosed by specific criteria.

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My headaches last 2 hours or more, even with treatment.

Exclusion Criteria

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

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I am allergic to or cannot take metoclopramide, ketorolac, or NSAIDs.

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I am experiencing headaches caused by another health condition.

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I do not have severe heart or brain blood vessel diseases.

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I have been diagnosed with congestive heart failure.

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I have epilepsy with more than 2 seizures a year.

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I have skin issues or implants on both upper arms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assessment of recruitment rate

Secondary study objectives

Adverse events

Discharged from the emergency department with no further intervention

Freedom from most bothersome symptom

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard-of-Care IV GroupExperimental Treatment3 Interventions

Patients randomised to the standard of care IV group will receive a single, 45-minute stimulation from a sham remote electrical neuromodulation (REN) device, which will not administer the typical electrical stimulation (modulated frequency of \~ 0.083 Hz and a modulated pulse width of 40-550 µs), and will be given a single dose IV ketorolac and IV metoclopramide, at a dose of 0.5 mg/kg (for a maximum 30 mg) and 0.15 mg/kg (for a maximum 10mg), respectively. Metoclopramide will be infused over 15-30 minutes and ketorolac will be administered as a direct IV push over 1-5 minutes.

Group II: REN GroupExperimental Treatment2 Interventions

Patients randomised to the REN group will receive a single 45-minutes stimulation from the REN device (modulated frequency of 100-120 Hz and a pulse width of 400 µs) and will also receive two doses of normal saline though an IV. Two doses of saline will be used to match the dosage, route of administration, and duration to ketorolac and metoclopramide, as described above in the standard-of-care IV group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metoclopramide

2016

Completed Phase 4

~29230

Placebo

1995

Completed Phase 3

~2670