Clinical trial NCT04010435: Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders
Official title: Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Vestibular Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Definite diagnosis with unilateral peripheral vestibular disorders from audiologist or neurologist.
2. The patient's age will be ranged from thirty to sixty years old.
3. Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
4. Symptoms of vertigo and nystagmus lasting from seconds to one minute.
5. Vertigo that arises from changes in head position related to gravity.
6. Patients who experienced symptoms for more than three months (chronic patients)
7. Patients were selected to be ambulant.
8. Patients suffer from balance disturbance with low risk falling (41-56) and moderate risk falling ranges (21-40) according to berg balance scale.
9. 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:

1. Benign positional vertigo.
2. Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").
3. Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").
4. Previous surgery of the ear.
5. Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
6. Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension \>190/110...).
7. Pacemaker or other implanted electrically sensitive device.
8. Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests).
9. Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression....).
10. Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).
11. Alcohol abuse.
12. Epilepsy.

Primary outcomes:
measure: Vestibular canal weakness
timeFrame: 1 mounth
measure: Dizziness handicapped inventory
timeFrame: 1 month
Secondary outcomes:
measure: Postural stability
timeFrame: 1 month
measure: Balance
timeFrame: 1 month
measure: Vestibular disorders activities of daily living
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
state: Giza
Study officials:
References: