A Research Study to Examine Cutaneous Allodynia and Cluster Headache
This study has been completed.
Sponsor:
Thomas Jefferson University
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329836
First received: May 24, 2006
Last updated: July 21, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cluster Headache |
Other: There are no interventions in the observational study. The symptom of allodynia was measured. |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Thomas Jefferson University:
Primary Outcome Measures:
- Prevalence of Allodynia in Subjects With Cluster Headache [ Time Frame: Allodynia was assessed at the screening visit ] [ Designated as safety issue: No ]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.
| Enrollment: | 41 |
| Study Start Date: | August 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Subjects with cluster headache
Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
|
Other: There are no interventions in the observational study. The symptom of allodynia was measured.
No intervention. Description of allodynia testing appears elsewhere in this document
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects with cluster headache
Criteria
Inclusion Criteria:
- Male and female patients aged 18-75, inclusive
- Diagnosis of cluster headache, episodic or chronic.
- Patients with episodic CH can be either in active cluster period or not.
- Ability to read and understand an informed consent form, where the study protocol is described.
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 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 an acute pain medication within 24 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329836
Locations
| United States, Pennsylvania | |
| Jefferson Headache Center/ Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
Sponsors and Collaborators
Thomas Jefferson University
Investigators
| Principal Investigator: | Abraham A. Ashkenazi, M.D. | Jefferson Headache Center/ thomas Jefferson University |
More Information
No publications provided
| Responsible Party: | Abraham A. Ashkenazi, MD, Doylestown Hospital |
| ClinicalTrials.gov Identifier: | NCT00329836 History of Changes |
| Other Study ID Numbers: | CA/CH/01 |
| Study First Received: | May 24, 2006 |
| Results First Received: | July 21, 2011 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cluster Headache Headache Trigeminal Autonomic Cephalalgias Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013