Local Sensory Nerve Block in the Treatment of Vestibular Migraine

Vestibular Migraine Clinical Trial

Official title:

Local Sensory Nerve Block in the Treatment of Vestibular Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472675
• Other study ID #: 12
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 29, 2024

Study information

• Verified date: January 2024
• Source: Pamukkale University
• Contact: Fazil N Ardic, MD
• Phone: 902582965799
• Email: fnardic[@]pau.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 29, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Vestibular Migraine

Intervention

Procedure:
• Botulinum toxin and bupivacain
Botulinum toxin A AND bupivacain( local anesthetic)

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli	Pamukkale

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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