Local Sensory Nerve Block in the Treatment of Vestibular Migraine

NCT ID: NCT05472675

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2024-06-01

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.

Conditions

Vestibular Migraine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

local anesthetic and botulinum toxin group

patients who have vestibular migraine and who accepted for study gruoup as local anesthetic and botulinum toxin group

Group Type: EXPERIMENTAL

Botulinum toxin and bupivacain

Intervention Type: PROCEDURE

Botulinum toxin A AND bupivacain( local anesthetic)

Interventions

Botulinum toxin and bupivacain

Botulinum toxin A AND bupivacain( local anesthetic)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Fazıl Necdet Ardıç

Head of Department of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fazıl N Ardıç, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Department

Locations

Pamukkale University

Denizli, Pamukkale, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

12

Identifier Type: -

Identifier Source: org_study_id