Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.

NCT00329771 | Completed Results

• 1 other identifier: EM-BA/AAA
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. This study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. The results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Allodynia During a Migraine Attack

  Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS). After each series of brushes the patient will be asked to rate the level of discomfort from "normal sensation" to "extremely painful or unpleasant" using a 100 mm visual analog scale (VAS).

  allodynia assessed within 4 hours from onset of migraine head pain

Study Arms (1)

Episodic migraineurs

Eligible subjects with episodic migraine (with or without aura)

Other: No intervention: We are testing for the presence of allodynia

Interventions

No intervention: We are testing for the presence of allodynia OTHER

We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.

Episodic migraineurs

Eligibility Criteria

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

Study Population

Subjects with episodic migraine, as defined by the International Headache Society,recruited from our office practice and the communitiy

You may qualify if:

• Male and female patients aged 18-65, inclusive
• Diagnosis of episodic migraine with or without aura.
• Ability to read and understand an informed consent form and study procedures

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 suffer from headache (of any type) 15 or more days per month
• 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 any acute pain medication (e.g. triptans, ergots, NSAIDs, opioids, butalbital, acetaminophen) for any indication within 12 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

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Abraham A. Ashkenazi, M.D./Principal Investigator
• Organization: Doylestown Hospital, Pennsylvania

aashkenzai2001@yahoo.com

215-625-2894

Study Officials

• Abraham A Ashkenazi, M.D.

  Jefferson Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 25, 2006
• Study Start: March 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: March 1, 2008
• Last Updated: March 27, 2024
• Results First Posted: April 21, 2014

Record last verified: 2024-03

Locations

US (1)