Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
NCT ID: NCT04166045
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2020-06-12
2021-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Sham
Treatment at the bicep location
Sham Treatment Location
The device applies transcutaneous electrical nerve stimulation to the bicep
Verum
Treatment at the hand location
Verum Treatment Location
The device applies transcutaneous electrical nerve stimulation to the hand
Interventions
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Sham Treatment Location
The device applies transcutaneous electrical nerve stimulation to the bicep
Verum Treatment Location
The device applies transcutaneous electrical nerve stimulation to the hand
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
* 4-14 migraine days per month
* Ability to provide informed consent
* Demonstrates no contraindication to the use of electrical nerve stimulation
* Capable and willing to follow all study-related procedures
Exclusion Criteria
* Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
* Any medical condition that would, in the opinion of the investigator, make the subject ineligible
* Has received botulinum toxin injections within the past 3 months
* Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
* Use of investigational drug/device therapy within the past 4 weeks
* Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy)
* No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study
18 Years
100 Years
ALL
No
Sponsors
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Theranova, L.L.C.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Scottsdale, Arizona, United States
Countries
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Other Identifiers
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CRD-01-1282-01
Identifier Type: -
Identifier Source: org_study_id
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