A Research Study to Examine Cutaneous Allodynia and Cluster Headache

NCT ID: NCT00329836

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-02-29

Brief Summary

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.

Conditions

Cluster Headache

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects with cluster headache

Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.

There are no interventions in the observational study. The symptom of allodynia was measured.

Intervention Type: OTHER

No intervention. Description of allodynia testing appears elsewhere in this document

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Stephen D. Silberstein

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abraham A. Ashkenazi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Jefferson Headache Center/ thomas Jefferson University

Locations

Jefferson Headache Center/ Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CA/CH/01

Identifier Type: -

Identifier Source: org_study_id