MigraineNCT00386880
Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs
An observational study of Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Sounds
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 2007
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult women and men with a diagnosis of episodic migraine
Who may be able to join
- 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.).
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- 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.).
Who cannot join
- 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).
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
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.
- Conditions
- Migraine
- Being tested
- Sounds
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoundsOther
| Study group | Role | What they receive |
|---|---|---|
| Subjects with episodic migraine with allodynia | These are subjects with episodic migraine with allodynia Receives: Other: Sounds | |
| Subjects with episodic migraine without allodynia | Subjects with episodic migraine without allodynia Receives: Other: Sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abraham A. Ashkenazi, M.D., Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386880
- Sponsor's protocol ID
- AA-Phono-CA
- Status last verified
- Aug 2014
- First submitted
- 11 Oct 2006
- Last updated
- 22 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20562466
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs
- ClinicalTrials.gov ID
- NCT00386880
- Acronym / sponsor ID
- AA-Phono-CA
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Oct 2006 (estimated)
- Results
- Posted 22 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with episodic migraine with allodynia | – | Other: SoundsThese are subjects with episodic migraine with allodynia |
| Subjects with episodic migraine without allodynia | – | Other: SoundsSubjects with episodic migraine without allodynia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women and men with a diagnosis of episodic migraine
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sounds | Other | Subjects with episodic migraine with allodynia, Subjects with episodic migraine without allodynia |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20562466Ashkenazi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham A. Ashkenazi, M.D. principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00386880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.