Vestibular MigraineNCT05508139
The Role Of Vestibular Rehabilitation Therapy In Management Of Vestibular Migraine Patients
An observational study of Vestibular Migraine, run by Assiut University.
Trial summary
1. To assess the criteria of positional vertigo in vestibular migraine patients 2. To assess the effect of vestibular rehabilitation therapy in management of positional vertigo in vestibular migraine patients Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Vestibular Migraine
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Adult
Study population: age from age 20 to 50 both male and femele
Who may be able to join
- Age: from 20 years to 50 years old.
- Sex: male or female.
- Vestibular migraine
Who cannot join
- Evidence of neurological or psychiatric illness.
- Patients with other types of headache.
- Evidence of active middle ear disease.
- History of head trauma, surgery or ototoxic drug therapy
- Exclude other causes of vestibular disorder
Trial locations and contacts
No sites are listed yet.
mohammad elmorsy contact
About this study
- To assess the criteria of positional vertigo in vestibular migraine patients
- To assess the effect of vestibular rehabilitation therapy in management of positional vertigo in vestibular migraine patients
Read the detailed description
Vestibular migraine(VM) is a variant of migraine where the patient reports recurrent vertigo lasting minutes to days. The migraine headache component may be present with associated light and sound sensitivity but the vestibular symptoms are usually prominent . Migraine prophylaxis has been shown to provide some benefit to help to prevent or abort acute attacks of vertigo .
Vestibular migraine has a life time prevalence of about 1 % and a 1-year prevalence of 0.9 % in the general population and accounts for about 7% of patients seen in dizziness clinics and 9 % of patients seen in migraine clinics .
The International Headache Society and the International Barany Society for Neuro-otology have developed a consensus document with diagnostic criteria for VM . This diagnosis was included in the appendix of the new international classification of headache disorders (ICHD)-3 beta version of headache classification .
Diagnostic criteria The criteria for VM combine the typical signs and symptoms of migraine with the exclusion criteria of other disorders that also elicit vestibular signs . As in migraine without aura, a diagnosis of VM mainly depends on the patient history, for so far there are no clinically useful biomarkers.
Vestibular migraine diagnostic criteria International Bárány Society for Neuro-Otology and the International Headache Society (2012):- A. At least five episodes fulfilling criteria C and D B. A current or past history of migraine without aura or migraine with aura C. Vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours D. At least 50 % of episodes are associated with at least one of the following three migrainous features
- Headache with at least two of the following four characteristics
- Unilateral location
- Pulsating quality
- Moderate or severe intensity
- Aggravation by routine physical activity
- Photophobia and phonophobia
- Visual aura The mechanisms underlying vestibular dysfunction that are related to migraine still need further study and clarification. One explanation proposed is a parallel activation of vestibular and cranial nociceptive pathways.
Experimental studies have demonstrated that trigeminal and vestibular ganglion cells share neurochemical properties and express serotonin, capsaicin, and purinergic receptors. Nociceptive and vestibular afferents with neurochemical similarities converge in brainstem structures like the parabrachial nucleus, the raphe nuclei, and the locus coeruleus. All of these structures play an important role in modulating the sensitivity of pain pathways.
The vestibular rehabilitation become one of the main treatment modalities for patients suffering from vestibular dysfunction, patients are referred for vestibular rehabilitation therapy with aim of helping to relieve them of symptoms of dizziness ,gaze instability, disequilibrium and to improve their functional status.
- Conditions
- Vestibular Migraine
What is being measured
The primary outcome is the main question the study is designed to answer.
The Role Of Vestibular Rehabilitation Therapy In Management Of Vestibular Migraine Patients
quantify the effects of vestibular migrine some of them are as following dizzness handicap inventory
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Dec 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelmawla hammad abdelmawla kassem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508139
- Sponsor's protocol ID
- vestibular rehablitation
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Vestibular Rehabilitation Therapy In Management Of Vestibular Migraine Patients
- ClinicalTrials.gov ID
- NCT05508139
- Acronym / sponsor ID
- vestibular rehablitation
- Conditions
- Vestibular Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To assess the criteria of positional vertigo in vestibular migraine patients
- To assess the effect of vestibular rehabilitation therapy in management of positional vertigo in vestibular migraine patients
Detailed description
Vestibular migraine(VM) is a variant of migraine where the patient reports recurrent vertigo lasting minutes to days. The migraine headache component may be present with associated light and sound sensitivity but the vestibular symptoms are usually prominent . Migraine prophylaxis has been shown to provide some benefit to help to prevent or abort acute attacks of vertigo .
Vestibular migraine has a life time prevalence of about 1 % and a 1-year prevalence of 0.9 % in the general population and accounts for about 7% of patients seen in dizziness clinics and 9 % of patients seen in migraine clinics .
The International Headache Society and the International Barany Society for Neuro-otology have developed a consensus document with diagnostic criteria for VM . This diagnosis was included in the appendix of the new international classification of headache disorders (ICHD)-3 beta version of headache classification .
Diagnostic criteria The criteria for VM combine the typical signs and symptoms of migraine with the exclusion criteria of other disorders that also elicit vestibular signs . As in migraine without aura, a diagnosis of VM mainly depends on the patient history, for so far there are no clinically useful biomarkers.
Vestibular migraine diagnostic criteria International Bárány Society for Neuro-Otology and the International Headache Society (2012):- A. At least five episodes fulfilling criteria C and D B. A current or past history of migraine without aura or migraine with aura C. Vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours D. At least 50 % of episodes are associated with at least one of the following three migrainous features
- Headache with at least two of the following four characteristics
- Unilateral location
- Pulsating quality
- Moderate or severe intensity
- Aggravation by routine physical activity
- Photophobia and phonophobia
- Visual aura The mechanisms underlying vestibular dysfunction that are related to migraine still need further study and clarification. One explanation proposed is a parallel activation of vestibular and cranial nociceptive pathways.
Experimental studies have demonstrated that trigeminal and vestibular ganglion cells share neurochemical properties and express serotonin, capsaicin, and purinergic receptors. Nociceptive and vestibular afferents with neurochemical similarities converge in brainstem structures like the parabrachial nucleus, the raphe nuclei, and the locus coeruleus. All of these structures play an important role in modulating the sensitivity of pain pathways.
The vestibular rehabilitation become one of the main treatment modalities for patients suffering from vestibular dysfunction, patients are referred for vestibular rehabilitation therapy with aim of helping to relieve them of symptoms of dizziness ,gaze instability, disequilibrium and to improve their functional status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- age from age 20 to 50 both male and femele
Key inclusion criteria (3 listed)
- Age: from 20 years to 50 years old.
- Sex: male or female.
- Vestibular migraine
Key exclusion criteria (5 listed)
- Evidence of neurological or psychiatric illness.
- Patients with other types of headache.
- Evidence of active middle ear disease.
- History of head trauma, surgery or ototoxic drug therapy
- Exclude other causes of vestibular disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Role Of Vestibular Rehabilitation Therapy In Management Of Vestibular Migraine Patients
Time frame: through study completion, an average of 1 year
quantify the effects of vestibular migrine some of them are as following dizzness handicap inventory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Background: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
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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.
mohammad elmorsy contact
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Migraine, run by Assiut University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelmawla kassem (01019319054, Abelmawla.Hammad@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Role Of Vestibular Rehabilitation Therapy In Management Of Vestibular Migraine Patients (time frame: through study completion, an average of 1 year). 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 NCT05508139, 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 19 Aug 2022.