Migraine Headache
Conditions
Keywords
caloric vestibular stimulation
Brief summary
This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.
Interventions
DEVICETNM device
Non-invasive neurostimulator, home-use treatment for up to 43 days.
Sponsors
Scion NeuroStim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (Note: Patients were permitted continued access to migraine abortive medications and were being treated at the Duke University headache clinic.) * A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently); * The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary. * Subject must be at least 18 years of age.
Exclusion criteria
* Individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury. * A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of migraine headache days | Length of the study, about 71 days | Daily Headache Diary will be used by subject. A headache day is defined as a twenty-four hour period which the subject has a headache. |
| Severity of each and of all headaches | Length of study, 71 days | Daily Headache Diary will be used by subject. Subject will assign the level of pain based on an eleven-point pain measurement scale from zero (no pain) to ten (most intense pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Monthly Headache Pain Score | Length of study, about 71 days | The monthly measure would be the cumulative maximal headache pain scores for all headache days (days on which the subject's head pain level is one or higher on the pain measurement scale) during the month. |
Countries
United States
Outcome results
None listed