Neurostimulation Device for Treatment of Migraine Headache
This is a prospective, non-randomized and unblinded study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator to treat migraine headaches in patients with episodic migraine headaches.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache|
- Number of migraine headache days [ Time Frame: Length of the study, about 71 days ] [ Designated as safety issue: No ]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 [ Time Frame: Length of study, 71 days ] [ Designated as safety issue: No ]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).
- Total Monthly Headache Pain Score [ Time Frame: Length of study, about 71 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Device: ThermoNeuroModulation (TNM) Device
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630044
|United States, North Carolina|
|Duke Medicine / Neurology|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Daniel Laskowitz, MD||Duke University|