N/A
Completed N=285
RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks
Source: ClinicalTrials.gov NCT02686034 ↗Enrolled (actual)
285
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Number of Participants With Treatment Response - No Pain — 36; 26 Participants
Summary
This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine attacks
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Response - No Pain |
36; 26 | — |
| SECONDARY Number of Participants With Absence of Nausea/Vomiting, Photophobia, Phonophobia |
83; 86; 110; 109; 76; 72 | — |
| SECONDARY Number of Participants With Treatment Response - No Pain or Mild Pain |
62; 50 | — |
| SECONDARY Number of Participants With Treatment Response no Pain or Mild Pain at 24 and 48 Hours. |
46; 37; 43; 33 | — |
| SECONDARY Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 2 All Attacks |
43; 28; 69; 41; 93; 66 | — |
Eligibility Criteria
Inclusion Criteria
- Is 18-75 years old.
- Has been previously diagnosed with migraine (with or without aura) in accordance with the ICHD-3 Beta classification criteria.
- Age of onset of migraines 160, diastolic >100 after 3 repeated measurements within 24 hours).
- Has a history of syncope or seizure (within the last 5 years).
- Has a known history or suspicion of substance abuse or addiction (within the last 5 years).
- Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study.
- Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled, prisoner).
- Is pregnant or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use an accepted form of birth control.
- Is a relative or employee of the Investigator or the clinical study site.
- Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- Has previously used the gammaCore device.
Data sourced from ClinicalTrials.gov (NCT02686034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.