Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache
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| City: |
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Durham |
| State: |
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North Carolina |
| Zip Code: |
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27705 |
| Conditions: |
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Migraine Headache |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- On a Monthly basis, at least four, and not more than a total of fourteen Headache
Days (Pain Score between one and ten) of which between four and nine are Migraine
Headache Days (Pain Score between five and ten). NOTE: For clarification, the
occurrence of Headaches is counted taking into account, and making no adjustments
for, the medications that the subjects are taking;
- 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 are pregnant, who have a history of cardiovascular disease, who work
night shifts or who have vestibular migraine, menstrual migraine, posttraumatic
migraine, a history of unstable mood disorder or unstable anxiety, moderate or
greater hearing loss or a history of traumatic brain injury will be excluded from the
Study.
- A history within the last six months of tobacco use, narcotic or barbiturates use or
experiencing one or more analgesic rebound headaches.
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| NCT ID: |
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NCT01630044 |
| Primary Contact: |
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Principal Investigator
Heather Adkins, MD
Duke University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Durham, North Carolina 27705
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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