Partial Rebreathing in the Treatment of Migraine With Aura

Overview

A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: September 2017

Interventions

  • Device: Active partial rebreathing device
  • Device: Dummy partial rebreathing device

Arms, Groups and Cohorts

  • Active Comparator: Active partial rebreathing device
  • Sham Comparator: Dummy partial rebreathing device

Clinical Trial Outcome Measures

Primary Measures

  • Headache Intensity Difference at 0 vs 2 hours post-treatment
    • Time Frame: 2 hours
    • 0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

Secondary Measures

  • Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale)
    • Time Frame: 1 hour
    • 0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
  • Pain reduction/relief at 1 hour
    • Time Frame: 1 hour
    • percentage of study participants reporting no or mild pain 1 hour after first using the device
  • Pain reduction/relief at 2 hours
    • Time Frame: 2 hours
    • percentage of study participants reporting no or mild pain 2 hours after first using the device
  • Nausea Intensity Difference 0 vs 1 hour post-treatment
    • Time Frame: 1 hour
    • 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
  • Nausea Intensity Difference 0 vs 2 hours post-treatment
    • Time Frame: 2 hours
    • 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
  • Photo – and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment
    • Time Frame: 1 hour
    • 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
  • Photo – and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment
    • Time Frame: 2 hours
    • 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
  • Functional Disability Difference 0 vs 1 hour post-treatment
    • Time Frame: 1 hour
    • 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
  • Functional Disability Difference 0 vs 2 hours post-treatment
    • Time Frame: 2 hours
    • 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
  • Sustained pain freedom at 24 hours
    • Time Frame: 24 hours
    • percentage of study participants who are pain free 24 hours after device use
  • Treatment preference vs. patient’s normal treatment
    • Time Frame: 24 hours
    • -2 to +2 scale ((-2 = much worse than normal treatment, – 1 = somewhat worse, 0 = no difference, +1 = somewhat better, +2 = much better))
  • Aura symptoms aborted after one use of device
    • Time Frame: 20 minutes
    • yes/no
  • Side effects
    • Time Frame: through study completion (1 to 10 months)
    • Qualitative analysis
  • Adverse events
    • Time Frame: through study completion (1 to 10 months)
    • Qualitative analysis
  • Medicine use in 24 hours after device use
    • Time Frame: 24 hours
    • qualitative comparison

Participating in This Clinical Trial

Inclusion Criteria

  • – Migraine with aura – Attack frequency of between one and six migraine-with-aura attacks per month over the last six months – Adults (18-60 years) – Age at onset of migraine < 50 years – If taking migraine prophylactic drugs, the dosis must have been stable for > 3 months – Must speak and understand Danish Exclusion Criteria:

  • – Cardiovascular disease, pulmonary disease, metabolic acid/base disorder, cancer, moderate and severe depression, anemia or other blood disease – Chronic migraine, i.e. more than 15 headache days per month over the last three months – Medication overuse headache – More than six migraine-with-aura attacks per month – Non-migraine headache on more than six days per month – A typical duration between migraine-with-aura attacks of less than 48 hours

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Collaborator
    • Aarhus University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Flemming W Bach, MD, PhD, Principal Investigator, Aarhus University Hospital

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