Migraine
Conditions
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.
Interventions
OTHERNo intervention: We are testing for the presence of allodynia
We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.
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
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Allodynia During a Migraine Attack | allodynia assessed within 4 hours from onset of migraine head pain | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Episodic Migraineurs Eligible subjects with episodic migraine (with or without aura) | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Episodic Migraineurs |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
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).
Time frame: allodynia assessed within 4 hours from onset of migraine head pain
Population: Participants who completed allodynia test
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Episodic Migraineurs | Proportion of Subjects With Allodynia During a Migraine Attack | 15 participants |