Neurostimulation Device for Treatment of Migraine Headache
|ClinicalTrials.gov Identifier: NCT01630044|
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Device: TNM device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: TNM device, active treatment
This is an active-only assessment of the experimental neuromodulation device
Device: TNM device
Non-invasive neurostimulator, home-use treatment for up to 43 days.
- Number of migraine headache days [ Time Frame: 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 [ Time Frame: 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).
- Total Monthly Headache Pain Score [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630044
|United States, North Carolina|
|Duke Medicine / Neurology|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Daniel Laskowitz, MD||Duke University|