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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)

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of recruitment rate

Secondary outcome measures

Adverse events

Discharged from the emergency department with no further intervention

Freedom from most bothersome symptom

+7 more

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

Placebo

1995

Completed Phase 3

~2670

Metoclopramide

2016

Completed Phase 4

~29230

Ketorolac

2014

Completed Phase 4

~1760

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

791 Previous Clinical Trials

868,712 Total Patients Enrolled

2 Trials studying Migraine

50 Patients Enrolled for Migraine

Serena L Orr, MD, MSc, FRCPCPrincipal InvestigatorUniversity of Calgary

Media Library

Active Remote Electrical Neuromodulation Device (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05102591 — Phase 3

Migraine Research Study Groups: Standard-of-Care IV Group, REN Group

Migraine Clinical Trial 2023: Active Remote Electrical Neuromodulation Device Highlights & Side Effects. Trial Name: NCT05102591 — Phase 3

Active Remote Electrical Neuromodulation Device (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05102591 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment only consider young participants?

"As per the requirements for this clinical trial, eligible participants must be aged between 8 and 18 years old."

Answered by AI

To whom does this study give the opportunity to participate?

"This trial is looking for 40 participants that fit the following criteria: a diagnosis of sick headache by a physician, age between 8 and 18, unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity, nausea and/or vomiting, photophobia and phonophobia, E. Not better accounted for by another diagnosis, B. Headache attacks lasting at least 2 hours, Criterion A is not being used in this study, the patient and their caregiver will also be required to understand spoken and written English, an upper arm circumference of at least 20 cm."

Answered by AI

How many people are eligible for this phase of the medical study?

"That is accurate. The most recent information available on clinicaltrials.gov suggests that this study is still looking for patients. It was originally posted on February 22nd, 2022 and updated on March 1st, 2022. So far, 40 patients have been recruited from 1 medical site."

Answered by AI

What are the main conditions that this medication is used to ameliorate?

"This treatment is not only useful for gastroparesis patients, but can also help those with pupil, pharmacotherapy, and miosis disorders."

Answered by AI

Can you give me some more information about this treatment and how it has been studied in the past?

"There are currently 51 ongoing clinical trials for this treatment, 10 of which are in Phase 3. Most of these studies are situated in Boston, Massachusetts; however, there are a total of 70 locations running trials for this treatment."

Answered by AI

Has this particular drug been greenlit by the FDA?

"This is a Phase 3 trial, which means that there is already some evidence supporting the efficacy of the treatment and that the treatment has been through multiple rounds of testing for safety. Our team at Power rate the safety of the treatment as a 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Serena Orr, MD, MSc, FRCPC 2022. "A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05102591.

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