- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04575623
Auditory Functions in Patients With Migraine
Central Auditory and Cognitive Functions in Patients Suffering From Migraine
Study Overview
Status
Conditions
Intervention / Treatment
- Diagnostic test: Duration Pattern test (DPT) /Dichotic Digits Test (DDT) /Auditory fusion test-revised (ART-R)/
- Device: Dual band pure tone audiometer (Orbiter 992). -Impedance audiometer (AT 235h). -Sound treated booth (industrial acoustic company IAC model 1602-A-t) -Panasonic stereo CD player SA-AK 240.
Detailed Description
The definition of central auditory processing CAP is based on auditory functions . Central auditory processing CAP involves a large number of skills which are highly dependent on a set integrity of the auditory pathways, from the outer ear to the auditory cortex. These skills include auditory selective attention, sound detection, and localization, discrimination of isolated and sequential sounds, as well as speech recognition, auditory comprehension and memory .
central auditory processing CAP is an indispensable tool for the investigation of the function of the central nervous system . The impairment of auditory processing could cause difficulties in complex listening situations, such as understanding speech in back-ground noise, rapid or degraded speech, and problems with comprehending verbal instructions.
Central auditory perception (CAP) can be assessed by Behavioral tests, which demonstrate good correlations with electrophysiological measures . Recording of event-related potentials (ERPs), because of its objectivity and noninvasive characteristics, presents one of the most useful tools in investigating neural substrates and cerebral regions involved in specific cognitive function. It implies recording of brain activity during a cognitive task .
Among the components of ERPs, theP300 is undoubtedly the most studied cerebral wave in evaluating cerebral information processing during the course of various neurological diseases because of its easy recording and reliability . The P300 develops if the subject is actively engaged in the task of detecting the targets.
Amplitude of the wave varies with the improbability of the targets and latency with the difficulty of discriminating the target stimulus from the standard stimuli . Typical peak latency P300 latency reflects timing of mental processes and the increase of latency represents prolongation of the processing time
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- It will consist of 100 patients suffering from migraine according to international classification of headache.
- Their age range from (18-40) years old which considered the most common affected age group ,
- Both sexes will be included.
- The study group will be further classified into two main categories migraine with and without aura.
Exclusion Criteria:
- Patients with history of systemic, neurologic or psychiatric illness.
- Patients with other types of headache.
- Patients with hearing loss.
- Patients with history of head trauma, surgery or ototoxic drug therapy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group
It will consist of 120 patients suffering from migraine according to international classification of headache
|
Central auditory function evaluation including:
Cognitive function evaluation including: -Recording of event-related potentials (ERPs) by using odd ball paradigm auditoryP300 wave in evaluating cerebral information processing. Equipment:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of central auditory processing in patients with migraine
Time Frame: One year
|
Evaluation of auditory functions in patients with migraine by using Duration Pattern test (DPT) designed to test temporal ordering abilities. Dichotic Digits Test (DDT) it assesses binaural integration skills. Auditory fusion test-revised (ART-R) to measure temporal resolution. speech in test to assess central auditory function. |
One year
|
Determination of cognitive functions in patients with migraine
Time Frame: One year
|
Evaluation of cognitive functions in patients with migraine by Recording of event-related potentials (ERPs) by using odd ball paradigm auditoryP300 wave in evaluating cerebral information processing
|
One year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Patients with migraine
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
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Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
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Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
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The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States