Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Subjects with episodic migraine without allodynia	Sounds	Subjects with episodic migraine without allodynia
Subjects with episodic migraine with allodynia	Sounds	These are subjects with episodic migraine with allodynia

Primary Outcome Measures

Name	Time	Method
Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine	Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.	Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.

Secondary Outcome Measures