A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
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: 16-009955
NCT ID: NCT02991430
Sponsor Protocol Number: SNS-MIG-02
About this study
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
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:
- Diagnosed with episodic migraine at least 6 months before study
- At least 3 consecutive months of stable migraine headaches before study
- At least 4-14 headache days per month, of which 4-14 may be migraines
- Must not have failed on more than 2 classes of migraine preventatives
Exclusion Criteria:
- Previous use of the experimental device
- Pregnant
- Using more than 1 concurrent migraine preventive
- History of cardiovascular disease
- Work night shifts
- Diagnosed with vestibular migraine
- Menstrual migraines exclusively
- Diagnosed with post-traumatic migraine
- Have a history of unstable mood or anxiety disorder
- Use a hearing aid
- Have a cochlear implant
- Have chronic tinnitus
- Have temporomandibular joint disease
- Diagnosed with traumatic brain injury
- Diagnosed with neurological disease other than headaches
- Diagnosed vestibular and/or balance dysfunction
- History of abusing alcohol or other drugs
- Are experiencing medication overuse headaches
- Have had eye surgery in the previous 3 months
- Have had ear surgery in the previous 6 months
- Have active ear infections or a perforated tympanic membrane
- Have participated in another clinical trial in the last 30 days
- Are currently participating in another clinical trial
- Using Botulinum toxin-based treatments for migraines or cosmetic reasons
- Taking anti-emetics more than 2 times per week (consistently)
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 Rashmi Halker Singh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available