Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders
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ClinicalTrials.gov Identifier: NCT04010435 |
Recruitment Status :
Recruiting
First Posted : July 8, 2019
Last Update Posted : January 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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Peripheral Vestibular Disorders | Device: repetitive transcranial magnetic stimulation Device: Galvanic stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders |
Actual Study Start Date : | February 1, 2019 |
Estimated Primary Completion Date : | May 30, 2021 |
Estimated Study Completion Date : | June 30, 2021 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Group A (r TMS group)
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.
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Device: repetitive transcranial magnetic stimulation
high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere. |
Active Comparator: Group B (Galvanic stimulation)
Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo galvanic vestibular stimulation; in addition to designed vestibular rehabilitation exercises.
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Device: Galvanic stimulation
galvanic stimulation of the vestibular apparatus |
No Intervention: Control (Group C)
Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises.
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- 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
- Postural stability [ Time Frame: 1 month ]Computerized dynamic Posturography- Scores ranging zero min score and 100 max score
- Balance [ Time Frame: 1 month ]Berg balance scale - 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56
- Vestibular disorders activities of daily living [ Time Frame: 1 month ]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)

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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
- 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.
Exclusion Criteria:
- 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…).
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010435
Contact: Reham A.M. Ahmed, Phd | 00201285059796 | rihamelsayed_pt@hotmail.com | |
Contact: Hesham M. S. Nafia, M.Sc | 00201017713483 | drhesham101@gmail.com |
Egypt | |
Cairo university | Recruiting |
Cairo, Giza, Egypt, 12613 | |
Contact: Reham A.M. Ahmed, phd 00201285059796 rihamelsayed_pt@hotmail.com |
Responsible Party: | Reham Ali Mohamed Ali Ahmed, Assistant Lecturer, Cairo University |
ClinicalTrials.gov Identifier: | NCT04010435 |
Other Study ID Numbers: |
P.T.REC/012/002202 |
First Posted: | July 8, 2019 Key Record Dates |
Last Update Posted: | January 14, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vestibular Diseases Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases |