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Vestibular MigraineNCT05508139

The Role Of Vestibular Rehabilitation Therapy In Management Of Vestibular Migraine Patients

An observational study of Vestibular Migraine, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

01098982464

About this study

  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 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted19 Aug 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

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)
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

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.

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