Comparing two types of stimulation for treating peripheral vestibular disorders

Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders

This study is testing two different brain stimulation methods to see which one helps people with balance and dizziness problems caused by inner ear issues feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 30 Years to 60 Years
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Locations: 1 site (Cairo, Giza)
• Trial ID: NCT04010435 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of two non-invasive brain stimulation techniques, repetitive transcranial magnetic stimulation (rTMS) and galvanic vestibular stimulation, in patients with unilateral peripheral vestibular disorders. Participants aged 30 to 60 will be randomly assigned to one of three groups, with outcomes measured using various balance and dizziness assessment tools before and after treatment. The study seeks to determine which stimulation method provides better relief from symptoms associated with vestibular dysfunction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 to 60 with a confirmed diagnosis of unilateral peripheral vestibular disorders experiencing chronic symptoms.

Not a fit: Patients with benign positional vertigo or central vestibular disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from peripheral vestibular disorders.

How similar studies have performed: Previous studies have shown promise in using rTMS for neurological disorders, suggesting potential success for this approach in vestibular disorders.

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.

Where this trial is running

Cairo, Giza

• Cairo university — Cairo, Giza, Egypt (Recruiting)

Study contacts

• Study coordinator: Reham A.M. Ahmed, Phd

Conditions Peripheral Vestibular Disorders