Peripheral Vestibular DisordersNCT04010435
Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders
A study testing repetitive transcranial magnetic stimulation and Galvanic stimulation in people with Peripheral Vestibular Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
Vestibular disorders are disabling conditions that can have a major effect on functioning especially on daily activities and social participation. Latest epidemiological studies estimate that as many as 35% of adults aged 40 years or older had experienced some form of vestibular dysfunction. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Peripheral Vestibular Disorders
- What is being tested?
- repetitive transcranial magnetic stimulation and Galvanic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 Dec 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definite diagnosis with unilateral peripheral vestibular disorders from audiologist or neurologist.
- The patient's age will be ranged from thirty to sixty years old.
- Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
- Symptoms of vertigo and nystagmus lasting from seconds to one minute.
- Vertigo that arises from changes in head position related to gravity.
- Patients who experienced symptoms for more than three months (chronic patients)
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- Patients were selected to be ambulant.
- Patients suffer from balance disturbance with low risk falling (41-56) and moderate risk falling ranges (21-40) according to berg balance scale.
- All patients were medically stable, controlled with medical drugs for at least three months and failed to medical treatment with no other physical, mental or cognitive disorders.
Who cannot join
- Benign positional vertigo.
- Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").
- Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").
- Previous surgery of the ear.
- Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
- Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension >190/110…).
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- Pacemaker or other implanted electrically sensitive device.
- Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests).
- Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression….).
- Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).
- Alcohol abuse.
- Epilepsy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo, Giza Governorate, 12613
Reham A.M. Ahmed, phd, 00201285059796, rihamelsayed_pt@hotmail.com
About this study
Official title: Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders
Vestibular disorders are disabling conditions that can have a major effect on functioning especially on daily activities and social participation. Latest epidemiological studies estimate that as many as 35% of adults aged 40 years or older had experienced some form of vestibular dysfunction. Non invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been investigated as therapeutic interventions for various neurological disorders like motor deficits and balance disorders after various neurological deficits. The purpose of this study is to compare between rTMs stimulation and galvanic vestibular stimulation in patients with unilateral peripheral vestibular disorders.
Read the detailed description
A pilot study has been recruited to calculate sample size and determine rTMs protocol that will be utilized during the study were two protocols has been compared and according to pilot study results collaborated with literature review a established protocol has been utilized. The subjects of both genders with age 30 to 60 will be allocated randomly into three equal groups A, B and C. Group A Outcomes measure will include : VNG (videonystagmography), Dizziness handicapped inventory, Berg balance scale, Vestibular disorders activities of daily living scale(VADL). Assessment will be done before and after treatment sessions.
- Conditions
- Peripheral Vestibular Disorders
- Being tested
- repetitive transcranial magnetic stimulation, Galvanic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.
Galvanic stimulationDevice
galvanic stimulation of the vestibular apparatus
| Study group | Role | What they receive |
|---|---|---|
| Group A (r TMS group) | Active comparator | Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises. Receives: Device: repetitive transcranial magnetic stimulation |
| Group B (Galvanic stimulation) | Active comparator | Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo galvanic vestibular stimulation; in addition to designed vestibular rehabilitation exercises. Receives: Device: Galvanic stimulation |
| Control (Group C) | No intervention | Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular canal weakness
Videonystagmography- Scores ranging zero min score and 100 max score
Measured: 1 mounth
Dizziness handicapped inventory
identify difficulties that you may be experiencing because of your dizziness- 25 items with max score 100 and min score zero
Measured: 1 month
Secondary outcomes (3)
Postural stability
Computerized dynamic Posturography- Scores ranging zero min score and 100 max score
Measured: 1 month
Balance
Berg balance scale - 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56
Measured: 1 month
Vestibular disorders activities of daily living
The Vestibular Disorders Activities of Daily Living (VADL) scale assesses the impact of vestibular impairment on everyday activities. The 28 items are grouped into three dimensions: functional (self-care and intimate activities), ambulation (walking and stair climbing), and instrumental (home management and leisure activities).Each item is rated with zero (min score) to 10 (max score)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Feb 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vestibular DisordersStudies of the same condition, open and under way.
- More trials run by Cairo 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, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ali Mohamed Ali Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010435
- Sponsor's protocol ID
- P.T.REC/012/002202
- Status last verified
- Feb 2024
- First submitted
- 3 Jul 2019
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders
- ClinicalTrials.gov ID
- NCT04010435
- Acronym / sponsor ID
- P.T.REC/012/002202
- Conditions
- Peripheral Vestibular Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Jul 2019 (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.
Vestibular disorders are disabling conditions that can have a major effect on functioning especially on daily activities and social participation. Latest epidemiological studies estimate that as many as 35% of adults aged 40 years or older had experienced some form of vestibular dysfunction. Non invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been investigated as therapeutic interventions for various neurological disorders like motor deficits and balance disorders after various neurological deficits. The purpose of this study is to compare between rTMs stimulation and galvanic vestibular stimulation in patients with unilateral peripheral vestibular disorders.
Detailed description
A pilot study has been recruited to calculate sample size and determine rTMs protocol that will be utilized during the study were two protocols has been compared and according to pilot study results collaborated with literature review a established protocol has been utilized. The subjects of both genders with age 30 to 60 will be allocated randomly into three equal groups A, B and C. Group A Outcomes measure will include : VNG (videonystagmography), Dizziness handicapped inventory, Berg balance scale, Vestibular disorders activities of daily living scale(VADL). Assessment will be done before and after treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (r TMS group) | Active comparator | Device: repetitive transcranial magnetic stimulationTwenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises. |
| Group B (Galvanic stimulation) | Active comparator | Device: Galvanic stimulationTwenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo galvanic vestibular stimulation; in addition to designed vestibular rehabilitation exercises. |
| Control (Group C) | No intervention | –Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Definite diagnosis with unilateral peripheral vestibular disorders from audiologist or neurologist.
- The patient's age will be ranged from thirty to sixty years old.
- Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
- Symptoms of vertigo and nystagmus lasting from seconds to one minute.
- Vertigo that arises from changes in head position related to gravity.
Key exclusion criteria (12 listed)
- Benign positional vertigo.
- Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").
- Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").
- Previous surgery of the ear.
- Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationhigh frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere. | Device | Group A (r TMS group) |
| Galvanic stimulationgalvanic stimulation of the vestibular apparatus | Device | Group B (Galvanic stimulation) |
Primary outcome
Vestibular canal weakness
Time frame: 1 mounth
Videonystagmography- Scores ranging zero min score and 100 max score
Dizziness handicapped inventory
Time frame: 1 month
identify difficulties that you may be experiencing because of your dizziness- 25 items with max score 100 and min score zero
3 secondary outcomes
Postural stability
Time frame: 1 month
Balance
Time frame: 1 month
Vestibular disorders activities of daily living
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation and Galvanic stimulation in people with Peripheral Vestibular Disorders, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham A.M. Ahmed, Phd (00201285059796, rihamelsayed_pt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular canal weakness (time frame: 1 mounth). The study lists 2 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 14 Feb 2024.