Migraine
Conditions
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.
Interventions
OTHERSounds
Sponsors
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Episodic Migraine Subjects with less than 8 distict migraine episodes per month. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Subjects With Episodic Migraine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
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.
Time frame: Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects With Episodic Migraine With Allodynia | Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine | 27 participants |
| Subjects With Episodic Migraine Without Allodynia | Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine | 6 participants |
Comparison: During the acute migraine attack, 90% of allodynic subjects and 75% of subjects without allodynia had phonophobia.p-value: 0.59Fisher Exact