Local Sensory Nerve Block in the Treatment of Vestibular Migraine

NCT05472675 | Completed

• 1 other identifier: 12
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Migraine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

  6 months

• Allodynia Symptom Checklist

  6 months

Study Arms (1)

local anesthetic and botulinum toxin group

EXPERIMENTAL

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

Procedure: Botulinum toxin and bupivacain

Interventions

Botulinum toxin and bupivacain PROCEDURE

Botulinum toxin A AND bupivacain( local anesthetic)

local anesthetic and botulinum toxin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• vestibuler migraine(IHCD3)
• probable vestibular migraine (IHCD3)

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20070, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Fazıl N Ardıç, MD

  Head of Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Otolaryngology

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 25, 2022
• Study Start: July 14, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)