Local Sensory Nerve Block in the Treatment of Vestibular Migraine

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Migraine
• Intervention / Treatment: Procedure: Botulinum toxin and bupivacain

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Pamukkale
    • Denizli, Pamukkale, Turkey, 20070
      • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: local anesthetic and botulinum toxin group; patients who have vestibular migraine and who accepted for study gruoup as local anesthetic and botulinum toxin group	Procedure: Botulinum toxin and bupivacain; Botulinum toxin A AND bupivacain( local anesthetic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MIDAS(Migraine Disability Assessment)	The 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%).	6 months
DHI(Dizziness Handicap Inventory)	The 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%).	6 months
VSS(Vertigo symptom sclae)	The 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%).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)	The 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	6 months
Allodynia Symptom Checklist	The 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.	6 months

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Fazıl N Ardıç, MD, Head of Department

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Acetylcholine Release Inhibitors; Bupivacaine; Botulinum Toxins
• Other Study ID Numbers: 12 (Israel lung Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No