A Research Study to Examine Cutaneous Allodynia and Cluster Headache

NCT00329836 | Completed Results

• 1 other identifier: CA/CH/01
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of Allodynia in Subjects With Cluster Headache

  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.

  Allodynia was assessed at the screening visit

Study Arms (1)

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.

Interventions

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

Subjects with cluster headache

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with cluster headache

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Headache Center/ Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Abraham Ashkenazi, M.D./ Prinicpal Investigator
• Organization: Doylestown Hospital

aashkenazi@yahoo.com

215-625-2894

Study Officials

• Abraham A. Ashkenazi, M.D.

  Jefferson Headache Center/ thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 25, 2006
• Study Start: August 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 28, 2025
• Results First Posted: August 16, 2011

Record last verified: 2025-02

Locations

US (1)