Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

NCT00386880 | Completed Results

• 1 other identifier: AA-Phono-CA
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about the occurrence of phonophobia (increased sensitivity to sound) and allodynia may help us understand how the pain system works in migraine. It is hoped that the knowledge gained from this trial may enable us to more effectively treat patients with migraine headache.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine

  Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.

  Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.

Study Arms (2)

Subjects with episodic migraine with allodynia

These are subjects with episodic migraine with allodynia

Other: Sounds

Subjects with episodic migraine without allodynia

Subjects with episodic migraine without allodynia

Other: Sounds

Interventions

Sounds OTHER

Subjects with episodic migraine with allodynia; Subjects with episodic migraine without allodynia

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

Adult women and men with a diagnosis of episodic migraine

You may qualify if:

• Age: 18 - 65 years, inclusive.
• Gender: male or female
• Diagnosis: Episodic migraine with or without aura, as defined by the International Headache Society (IHS), for at least 6 months prior to enrollment.
• An average of ≥1 migraine attack per month over the 6-month period prior to enrollment.
• An average of \<15 headache (of any type) days per month for the 6 months prior to enrollment.
• Normal audiogram. (A hearing threshold of 20 dB or less at the frequency range of 200-8000Hz.).
• Age: 18 - 65 years, inclusive.
• Gender: male or female
• Non-headache sufferers with the exception of infrequent ETTH according to IHS criteria (lifetime occurrence of at least 10 episodes occurring on \<1 day per month on average and \<12 days per year)
• Normal audiogram, (A hearing threshold of 20 dB or less at the frequency range of 200-8000Hz.).

You may not qualify if:

• Use of any headache preventive drug (determined by investigator) in the 90 days prior to screening.
• Treatment with botulinum toxin (for any indication) within the 90 day period prior to enrollment.
• Treatment with occipital nerve block or block, or block of any other nerve in the head or neck area, within the 30 day period prior to enrollment.
• Any dermatological disease that may affect skin sensation.
• Any neurological disease that may affect sensory functions (e.g stroke, multiple sclerosis, peripheral neuropathy).
• Cognitive disturbance that may affect the subject's ability to understand the study procedure.
• Significant psychiatric disturbance that may impair the subject from co-operating with the study procedures.
• Use of acute pain medications on a daily or frequent pattern (for any indication) as defined by the IHS.
• Any other headache diagnosis except for IHS-defined infrequent ETTH.
• Use of any headache preventive drug (determined by investigator) in the 90 days prior to screening.
• Treatment with botulinum toxin (for any indication) within the 90 day period prior to enrollment.
• Treatment with occipital nerve block or block, or block of any other nerve in the head or neck area, within the 30 day period prior to enrollment.
• Any dermatological disease that may affect skin sensation.
• Any neurological disease that may affect sensory functions (e.g stroke, multiple sclerosis, peripheral neuropathy).
• Cognitive disturbance that may affect the subject's ability to understand the study procedure.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Ashkenazi A, Yang I, Mushtaq A, Oshinsky ML. Is phonophobia associated with cutaneous allodynia in migraine? J Neurol Neurosurg Psychiatry. 2010 Nov;81(11):1256-60. doi: 10.1136/jnnp.2009.198481. Epub 2010 Jun 20.

  PMID: 20562466 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sound

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Abraham A. Ashkenazi, MD-Principal Investigator
• Organization: Doylestown Hospital

aashkenazi2001@yahoo.com

215-625-2894

Study Officials

• Abraham A. Ashkenazi, M.D.

  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: SPONSOR

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 12, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 22, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08

Locations

US (1)