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This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with cluster headache | Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There are no interventions in the observational study. The symptom of allodynia was measured. | Other | No intervention. Description of allodynia testing appears elsewhere in this document |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Allodynia in Subjects With Cluster Headache | Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale. | Allodynia was assessed at the screening visit |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with cluster headache
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| Name | Affiliation | Role |
|---|---|---|
| Abraham A. Ashkenazi, M.D. | Jefferson Headache Center/ thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Headache Center/ Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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Subjects with cluster headache recruited from Jefferson Headache Center office practice or community. First subject enrolled 7/5/05. Last subject enrolled 6/9/06.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Cluster Headache | Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Cluster Headache | Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of Allodynia in Subjects With Cluster Headache | Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale. | All enrolled subjects were analyzed | Posted | Number | participants | Allodynia was assessed at the screening visit |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Cluster Headache | Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abraham Ashkenazi, M.D./ Prinicpal Investigator | Doylestown Hospital | 215-625-2894 | aashkenazi@yahoo.com |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
|
|
| 0 |
| 41 |
| 0 |
| 41 |
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| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |