search
Back to results

Local Sensory Nerve Block in the Treatment of Vestibular Migraine

Primary Purpose

Vestibular Migraine

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Botulinum toxin and bupivacain
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Migraine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

local anesthetic and botulinum toxin group

beta-blocker control group

Arm Description

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

patients who have vestibular migraine and who have standard migraine treatment as beta-blocker

Outcomes

Primary Outcome Measures

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%).
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%).
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%).

Secondary Outcome Measures

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
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.

Full Information

First Posted
July 14, 2022
Last Updated
January 1, 2023
Sponsor
Pamukkale University
search

1. Study Identification

Unique Protocol Identification Number
NCT05472675
Brief Title
Local Sensory Nerve Block in the Treatment of Vestibular Migraine
Official Title
Local Sensory Nerve Block in the Treatment of Vestibular Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local anesthetic and botulinum toxin group
Arm Type
Experimental
Arm Description
patients who have vestibular migraine and who accepted for study gruoup as local anesthetic and botulinum toxin group
Arm Title
beta-blocker control group
Arm Type
No Intervention
Arm Description
patients who have vestibular migraine and who have standard migraine treatment as beta-blocker
Intervention Type
Procedure
Intervention Name(s)
Botulinum toxin and bupivacain
Intervention Description
Botulinum toxin A AND bupivacain( local anesthetic)
Primary Outcome Measure Information:
Title
MIDAS(Migraine Disability Assessment)
Description
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%).
Time Frame
6 months
Title
DHI(Dizziness Handicap Inventory)
Description
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%).
Time Frame
6 months
Title
VSS(Vertigo symptom sclae)
Description
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%).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Description
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
Time Frame
6 months
Title
Allodynia Symptom Checklist
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fazil N Ardic, MD
Phone
902582965799
Email
fnardic@pau.edu.tr
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fazıl N Ardıc, MD
Phone
+902582965799
Email
fnardic@pau.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Local Sensory Nerve Block in the Treatment of Vestibular Migraine

We'll reach out to this number within 24 hrs