Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-011981
NCT ID: NCT04166045
Sponsor Protocol Number: CRD-01-1282-01
About this study
The study sponsor has developed a non-invasive treatment for reducing migraine pain. The Theranova Migraine Treatment System uses electrical stimulation applied to the skin.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 18-100 years, inclusive.
- 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:
- Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Amaal Starling, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available