Migraine

REN Migraine Study

A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents Visiting the Emergency Department

Study Summary

One in ten children and adolescents suffer from migraine and often come to the emergency department (ED) with migraine attacks. There is little evidence on how to treat migraine in children and adolescents in the ED. The evidence is limited to intravenous (IV) interventions, which are associated with high complication rates, costs, and patient fears about pain. Remote electrical neuromodulation (REN) has a scientifically valid mechanism of action and promising clinical data in adolescents and adults showing that REN can safely treat migraine very effectively when used at home (~70% of patients achieved pain relief which is comparable to rates observed with first-line ED interventions: IV metoclopramide and IV ketorolac). We will be recruiting children and adolescents with migraine attacks to determine the feasibility and acceptability of using a REN device for treatment in the ED.

The REN Migraine Study will be a pilot, double-dummy, randomized controlled trial. A total of 40 children and adolescents presenting to the ED with migraine attacks between 8 and 18 years old will be enrolled in the study. Study participants will be randomized to receive either:

  1. IV ketorolac (0.5mg/kg, max 30 mg), IV metoclopramide (0.15mg/kg, max 10 mg) and stimulation from a sham REN device, OR
  2. IV placebo (i.e. matched normal saline) and electrical stimulation from an active REN device

Objectives

  1. To determine the feasibility of comparing REN to the standard of care IV intervention (a combination of metoclopramide and ketorolac) for the treatment of children and adolescents visiting the ED with acute attacks of migraine
  2. To determine the acceptability of the study design and of using REN to treat children and adolescents visiting the ED with acute attacks of migraine
  3. To gather preliminary efficacy and safety data on the use of REN to treat children and adolescents visiting the ED with acute attacks of migraine

Principal Study Investigator: Dr. Serena Orr

Leading Institution: University of Calgary

PERT Site Investigator: Dr. Stephen Freedman

Study Team: Dr. Adam Kirton, Dr. Katie Birnie, Dr. Tolulope Sajobi, Dr. Samina Ali, Dr. Andrew Hershey

REN Migraine study publications