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A Research Study to Examine Cutaneous Allodynia and Cluster Headache

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329836
First Posted: May 25, 2006
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Thomas Jefferson University
  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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abraham A. Ashkenazi, MD, Doylestown Hospital
ClinicalTrials.gov Identifier: NCT00329836     History of Changes
Other Study ID Numbers: CA/CH/01
First Submitted: May 24, 2006
First Posted: May 25, 2006
Results First Submitted: July 21, 2011
Results First Posted: August 16, 2011
Last Update Posted: August 16, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases