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Local Sensory Nerve Block in the Treatment of Vestibular Migraine

Local Sensory Nerve Block in the Treatment of Vestibular Migraine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05472675
Enrollment
29
Registered
2022-07-25
Start date
2022-07-14
Completion date
2024-06-01
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Migraine

Brief summary

There is no standard approach to the treatment of vestibular migraine. Agents used in the treatment of migraine are frequently used. In treating migraine, local anesthetic agents, nerve-blocking methods, and botulinum toxin local injection is commonly applied, and successful results are obtained. Adapting the nerve-blocking method used in the treatment of migraine to the treatment of vestibular migraine is the purpose of the study.

Detailed description

Patients between 18-75 diagnosed with/without aura or chronic migraine according to IHCD-3 diagnostic criteria and who describe dizziness during or between attacks will be evaluated in the ENT clinic. Patients included in the study will be recorded as definite vestibular migraine or probable vestibular migraine according to criteria defined in the BARANY community and IHCD-3. Differential diagnosis of vertigo will be made with pure tone audiometry, Caloric test, VHIT, Videonystagmography, and cVEMP. MIDAS (migraine disability scale), DHI (dizziness handicap inventory), VSS (vertigo symptom scale), DASÖ-21 anxiety test, and Allodynia Symptom Checklist (ASKL) forms will be filled. Patients will be randomly divided into two groups. Patients in the control group will be given beta-blocker therapy, the standard treatment. The local anesthetic agent bupivacaine will be injected into the greater/small occipital nerves and supratrochlear/ supraorbital nerves. Patients in the study group will be asked to keep a diary of pain, dizziness, and painkiller use for one month. At the end of the 1st month, the scoring will be repeated, and the patients who show a decrease in half will be accepted to the next stage, botulinum toxin application. BoNT/A botulinum toxin A (botox; Allergan) will be injected bilaterally into the same regionns. All scoring will be repeated in the 1st, 3rd and 6th months.

Interventions

PROCEDUREBotulinum toxin and bupivacain

Botulinum toxin A AND bupivacain( local anesthetic)

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* vestibuler migraine(IHCD3) * probable vestibular migraine (IHCD3)

Exclusion criteria

* Systemic disorders unsuitable for injection administration * Keloidal scarring * Neuromuscular disorders * Botulinum toxin allergies * Body dysmorphic disorder * Pregnancy * Breastfeeding * Amyotrophic lateralizing sclerosis myopathies

Design outcomes

Primary

MeasureTime frameDescription
MIDAS(Migraine Disability Assessment)6 monthsThe MIDAS (Migraine Disability Assessment) questionnaire is used to measure the impact of headaches. It will be measured at baseline and 6 months after treatment to assess the effects of treatment on vestibular symptoms. Complete recovery will result in significant recovery (\>50%), moderate recovery (25-50% reduction), and minimal recovery (\<25%).
DHI(Dizziness Handicap Inventory)6 monthsThe DHI is a 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. It will be measured at baseline and 6 months after treatment to assess the effects of treatment on vestibular symptoms. Complete recovery will result in significant recovery (\>50%), moderate recovery (25-50% reduction), and minimal recovery (\<25%).
VSS(Vertigo symptom sclae)6 monthsThe VSS assesses patient-reported symptoms of vestibüler disease. Complete recovery will result in significant recovery (\>50%), moderate recovery (25-50% reduction), and minimal recovery (\<25%).

Secondary

MeasureTime frameDescription
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)6 monthsThe relationship between the improvement of vertiginous symptoms and the improvement of psychiatric symptoms will be observed. To evaluate this result, the difference between baseline and post-treatment DASS-21 will be compared
Allodynia Symptom Checklist6 monthsThe relationship between the improvement of vertiginous symptoms and cutaneous symptoms will be observed. To evaluate this result, the difference between baseline and post-treatment ASCL scores will be compared.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026