Vestibular MigraineNCT03417596
Vestibular Rehabilitation in Patients With Vestibular Migraine
A study testing Vestibular Rehabilitation in people with Vestibular Migraine and Vestibular Disorder, run by Ege University.
Trial summary
Abstract: Introduction: Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients with or without migraine type headaches, when present accompanying the headaches. Its prevalence was found out as %1 in a study in Germany. It usually involves middle aged women. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vestibular Migraine, Vestibular Disorder, Migraine Variant
- What is being tested?
- Vestibular Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2015to 15 Apr 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1-Vestibular Migraine diagnosis according to International Classification of Headache Disorders (3 rd edition-Beta version) 2- No history of vestibular rehabilitation or exercises
Who cannot join
- History of psychiatric disorder which might interfere with compliance to study
- Other diagnosis that might possibly cause vestibular disorder(cerebellar disorders, Meniere disease etc)
- Anatomical defects of the inner ear or vestibular system
- Patients who are unable to stand up straight or walk
About this study
Official title: Efficacy of Vestibular Rehabilitation in Patients With Vestibular Migraine
Abstract: Introduction:
Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients with or without migraine type headaches, when present accompanying the headaches. Its prevalence was found out as %1 in a study in Germany. It usually involves middle aged women. VM can make a huge impact on quality of life, therefore advances in its diagnosis and management are valuable. While pharmacotherapy that is being used in migraine can be beneficial, vestibular rehabilitation(VR) programmes are predicted to be one of the most important types of treatment in management of VM. This study compares the results of pharmacological management options and vestibular rehabilitation programmes in the context of dizziness, balance problems and headache.
Read more
Material and methods:
77 patients with VM were included in study, and 60 of them completed it. While one group took only VR programme, and another took only pharmacological prophylaxis. The third group took a combined therapy, and the groups were consisted of 20 patients. Patients were assessed with caloric tests, audiometric studies, static posturography, Dizziness Handicap Inventory(DHI), and Activities Specific Balance Confidence(ABC) scales. All of the assessments were applied 3 times throughout the study, and the results were compared with relevant statistical tests.
- Conditions
- Vestibular Migraine, Vestibular Disorder, Migraine Variant
- Being tested
- Control, Vestibular Rehabilitation
- Medical subject headings
- Vestibular Diseases, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Routine treatment
Vestibular RehabilitationBehavioural
Exercise and rehabilitation programme was individualized
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation | Experimental | Adaptation Exercises The exercises were performed in horizontal and vertical planes, for a period of one minute each, three times a day.
Substitution Exercises Standing dynamic balance exercises: The patient stands and moves without walking. The patient might march in place, step forward or backward, step to the side, step up or down, or turn around.
Habituation exercises: These exercises that cause mild to moderate difficulty in daily life was given as an exercise to the patient. These exercises involved movements and positions sufficient to cause mild-to-moderate symptoms during the patient's daily activities Ambulation exercises: Exercises that include walking with head moving towards different sides.
The exercise program consisted of one session per week for a period of eight weeks. Each session lasted approximately 30-45 minutes and was conducted in the rehabilitation unit. Receives: Behavioral: Vestibular Rehabilitation |
| Vestibular Rehabilitation+Pharmacological Therapy | Experimental | Same exercises that were applied in first group were also applied to this group.
For pharmacological therapy, patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated. Receives: Other: Control; Behavioral: Vestibular Rehabilitation |
| Pharmacological Therapy only | Other | Patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory
A standardized inventory to assess the impact of dizziness in patients' life.
Measured: 6 months
Activities-specific balance confidence scale
A scale which is used to evaluate balance confidence of patients in some specific activities. Confidence in daily activities requiring balance is rated by subject as percentage(from %0 to %100). Higher percentage relates to better confidence in balance.
Measured: 6 months
Static Posturography
Static posturography was performed using the NeuroCom System Version 8.0.3 (NeuroCom International Inc., Clackamas, OR, USA). Mean center of gravity (COG) sway velocity (°/s) was recorded on a static platform with eyes open (ST-EO) and closed (ST-EC) and on foam with eyes open (FO-EO) and closed (FO-EC)
Measured: 6 months
Secondary outcomes (1)
Vertigo attack severity
Self reported outcome in which patients give insight about their vertigo attack severity
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 posted31 Jan 2018
- Study start10 Jan 2015
- Primary completion10 Apr 2016
- Study completion15 Apr 2016
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 Ege 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen Gökçay, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417596
- Sponsor's protocol ID
- VM-Rehab
- Status last verified
- Jan 2018
- First submitted
- 14 Jan 2018
- Last updated
- 31 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vestibular Rehabilitation in Patients With Vestibular Migraine
- ClinicalTrials.gov ID
- NCT03417596
- Acronym / sponsor ID
- VM-Rehab
- Conditions
- Vestibular Migraine, Vestibular Disorder, Migraine Variant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 10 Apr 2016 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 31 Jan 2018 (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.
Abstract: Introduction:
Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients with or without migraine type headaches, when present accompanying the headaches. Its prevalence was found out as %1 in a study in Germany. It usually involves middle aged women. VM can make a huge impact on quality of life, therefore advances in its diagnosis and management are valuable. While pharmacotherapy that is being used in migraine can be beneficial, vestibular rehabilitation(VR) programmes are predicted to be one of the most important types of treatment in management of VM. This study compares the results of pharmacological management options and vestibular rehabilitation programmes in the context of dizziness, balance problems and headache.
Material and methods:
77 patients with VM were included in study, and 60 of them completed it. While one group took only VR programme, and another took only pharmacological prophylaxis. The third group took a combined therapy, and the groups were consisted of 20 patients. Patients were assessed with caloric tests, audiometric studies, static posturography, Dizziness Handicap Inventory(DHI), and Activities Specific Balance Confidence(ABC) scales. All of the assessments were applied 3 times throughout the study, and the results were compared with relevant statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation | Experimental | Behavioral: Vestibular RehabilitationAdaptation Exercises The exercises were performed in horizontal and vertical planes, for a period of one minute each, three times a day. Substitution Exercises Standing dynamic balance exercises: The patient stands and moves without walking. The patient might march in place, step forward or backward, step to the side, step up or down, or turn around. Habituation exercises: These exercises that cause mild to moderate difficulty in daily life was given as an exercise to the patient. These exercises involved movements and positions sufficient to cause mild-to-moderate symptoms during the patient's daily activities Ambulation exercises: Exercises that include walking with head moving towards different sides. The exercise program consisted of one session per week for a period of eight weeks. Each session lasted approximately 30-45 minutes and was conducted in the rehabilitation unit. |
| Vestibular Rehabilitation+Pharmacological Therapy | Experimental | Other: Control, Behavioral: Vestibular RehabilitationSame exercises that were applied in first group were also applied to this group. For pharmacological therapy, patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated. |
| Pharmacological Therapy only | Other | Other: ControlPatients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1-Vestibular Migraine diagnosis according to International Classification of Headache Disorders (3 rd edition-Beta version) 2- No history of vestibular rehabilitation or exercises
Key exclusion criteria (4 listed)
- History of psychiatric disorder which might interfere with compliance to study
- Other diagnosis that might possibly cause vestibular disorder(cerebellar disorders, Meniere disease etc)
- Anatomical defects of the inner ear or vestibular system
- Patients who are unable to stand up straight or walk
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 |
|---|---|---|
| ControlRoutine treatment | Other | Pharmacological Therapy only, Vestibular Rehabilitation+Pharmacological Therapy |
| Vestibular RehabilitationExercise and rehabilitation programme was individualized | Behavioural | Vestibular Rehabilitation, Vestibular Rehabilitation+Pharmacological Therapy |
Primary outcome
Dizziness Handicap Inventory
Time frame: 6 months
A standardized inventory to assess the impact of dizziness in patients' life.
Activities-specific balance confidence scale
Time frame: 6 months
A scale which is used to evaluate balance confidence of patients in some specific activities. Confidence in daily activities requiring balance is rated by subject as percentage(from %0 to %100). Higher percentage relates to better confidence in balance.
Static Posturography
Time frame: 6 months
Static posturography was performed using the NeuroCom System Version 8.0.3 (NeuroCom International Inc., Clackamas, OR, USA). Mean center of gravity (COG) sway velocity (°/s) was recorded on a static platform with eyes open (ST-EO) and closed (ST-EC) and on foam with eyes open (FO-EO) and closed (FO-EC)
1 secondary outcome
Vertigo attack severity
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 31 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Vestibular Migraine
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation in people with Vestibular Migraine and Vestibular Disorder, run by Ege University.
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 1 inclusion and 4 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Dizziness Handicap Inventory (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 31 Jan 2018.