A Research Study to Examine Cutaneous Allodynia and Cluster Headache - Full Text View

Sponsor:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00329836

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 IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Headache

U.S. FDA Resources

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 February 09, 2012