Vestibular MigraineNCT05472675
Local Sensory Nerve Block in the Treatment of Vestibular Migraine
A study testing Botulinum toxin and bupivacain in people with Vestibular Migraine, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vestibular Migraine
- What is being tested?
- Botulinum toxin and bupivacain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- vestibuler migraine(IHCD3)
- probable vestibular migraine (IHCD3)
Who cannot join
- Systemic disorders unsuitable for injection administration
- Keloidal scarring
- Neuromuscular disorders
- Botulinum toxin allergies
- Body dysmorphic disorder
- Pregnancy
- Breastfeeding
- Amyotrophic lateralizing sclerosis myopathies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20070
About this study
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.
Read the 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
- Being tested
- Botulinum toxin and bupivacain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin and bupivacainProcedure or surgery
Botulinum toxin A AND bupivacain( local anesthetic)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Botulinum toxin and bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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%).
Measured: 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%).
Measured: 6 months
Secondary outcomes (2)
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
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start14 Jul 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazıl N Ardıç, MD, Principal investigator, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472675
- Sponsor's protocol ID
- 12
- Status last verified
- Jun 2025
- First submitted
- 14 Jul 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Sensory Nerve Block in the Treatment of Vestibular Migraine
- ClinicalTrials.gov ID
- NCT05472675
- Acronym / sponsor ID
- 12
- Conditions
- Vestibular Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| local anesthetic and botulinum toxin group | Experimental | Procedure: Botulinum toxin and bupivacainpatients who have vestibular migraine and who accepted for study gruoup as local anesthetic and botulinum toxin group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- vestibuler migraine(IHCD3)
- probable vestibular migraine (IHCD3)
Key exclusion criteria (8 listed)
- Systemic disorders unsuitable for injection administration
- Keloidal scarring
- Neuromuscular disorders
- Botulinum toxin allergies
- Body dysmorphic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin and bupivacainBotulinum toxin A AND bupivacain( local anesthetic) | Procedure or surgery | local anesthetic and botulinum toxin group |
Primary outcome
MIDAS(Migraine Disability Assessment)
Time frame: 6 months
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)
Time frame: 6 months
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)
Time frame: 6 months
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%).
2 secondary outcomes
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time frame: 6 months
Allodynia Symptom Checklist
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Vestibular Migraine
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
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Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
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Acute Treatment of Vestibular Migraine by Rimegepant
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Efficacy of Cognitive Behavioral Therapy at Vestibular Migraine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazıl N Ardıç, MD principal investigator
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin and bupivacain in people with Vestibular Migraine, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIDAS(Migraine Disability Assessment) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.