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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNM device, active treatment | Experimental | This is an active-only assessment of the experimental neuromodulation device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM device | Device | Non-invasive neurostimulator, home-use treatment for up to 43 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of migraine headache 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. | Length of the study, about 71 days |
| Severity of each and of all headaches | 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). | Length of study, 71 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Monthly Headache Pain Score | 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. | Length of study, about 71 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Laskowitz, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medicine / Neurology | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27777829 | Background | Black RD, Rogers LL, Ade KK, Nicoletto HA, Adkins HD, Laskowitz DT. Non-Invasive Neuromodulation Using Time-Varying Caloric Vestibular Stimulation. IEEE J Transl Eng Health Med. 2016 Oct 7;4:2000310. doi: 10.1109/JTEHM.2016.2615899. eCollection 2016. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |