Clinical trial NCT00386880: Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs
Official title: Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2006-10-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women and men with a diagnosis of episodic migraine

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.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for migraine subjects:

* 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.).

Inclusion criteria for control subjects:

* 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.).

Exclusion criteria for migraine subjects:

* Any other headache diagnosis (e.g. cluster headache, hemicrania continua, post traumatic headache, etc.) except for episodic tension type headache (ETTH) with an average of no more than 10 ETTH headache days per month for the 6 months prior to enrollment (note: average \<15 total HA days is specified in inclusion)
* 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.

Exclusion criteria for control subjects:

* 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.
* 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.

Primary outcomes:
measure: Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine
timeFrame: Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Abraham A. Ashkenazi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.