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Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386880
First Posted: October 12, 2006
Last Update Posted: August 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University
  Purpose
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.

Condition Intervention
Migraine Other: Sounds

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine [ Time Frame: 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.


Enrollment: 38
Study Start Date: August 2006
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult women and men with a diagnosis of episodic migraine
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386880


Locations
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Abraham A. Ashkenazi, M.D. Thomas Jefferson University
  More Information

Publications:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00386880     History of Changes
Other Study ID Numbers: AA-Phono-CA
First Submitted: October 11, 2006
First Posted: October 12, 2006
Results First Submitted: August 5, 2012
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Hyperalgesia
Hyperacusis
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases