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Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.
This study has been completed.
Sponsor:
Thomas Jefferson University
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329771
First received: May 24, 2006
Last updated: March 14, 2014
Last verified: March 2014
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Purpose
Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. This study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. The results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.
| Condition | Intervention |
|---|---|
| Migraine | Other: No intervention: We are testing for the presence of allodynia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Brush Allodynia in Patients With Episodic Migraine During an Acute Attack. |
Resource links provided by NLM:
Further study details as provided by Thomas Jefferson University:
Primary Outcome Measures:
- Proportion of Subjects With Allodynia During a Migraine Attack [ Time Frame: allodynia assessed within 4 hours from onset of migraine head pain ]Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS).
| Enrollment: | 28 |
| Study Start Date: | March 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Episodic migraineurs
Eligible subjects with episodic migraine (with or without aura)
|
Other: No intervention: We are testing for the presence of allodynia
We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects with episodic migraine, as defined by the International Headache Society,recruited from our office practice and the communitiy
Criteria
Inclusion Criteria:
- Male and female patients aged 18-65, inclusive
- Diagnosis of episodic migraine with or without aura.
- Ability to read and understand an informed consent form and study procedures
Exclusion Criteria:
- Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
- Patients who suffer from headache (of any type) 15 or more days per month
- Patients who are cognitively impaired, as determined by investigator
- Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
- Patients who had taken any acute pain medication (e.g. triptans, ergots, NSAIDs, opioids, butalbital, acetaminophen) for any indication within 12 hours prior to allodynia testing.
- Patients with skin diseases that may cause abnormal skin sensation.
- Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00329771
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329771
Locations
| United States, Pennsylvania | |
| Jefferson Headache Center | |
| Philadelphia, Pennsylvania, United States, 19107 | |
Sponsors and Collaborators
Thomas Jefferson University
Investigators
| Principal Investigator: | Abraham A Ashkenazi, M.D. | Jefferson Headache Center |
More Information
| Responsible Party: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00329771 History of Changes |
| Other Study ID Numbers: |
EM-BA/AAA |
| Study First Received: | May 24, 2006 |
| Results First Received: | March 4, 2014 |
| Last Updated: | March 14, 2014 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on July 18, 2017