A Research Study to Examine Cutaneous Allodynia and Cluster Headache

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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Key information

Conditions

Cluster Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jefferson Headache Center/ Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: May 25, 2006
Registry last updated: Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed