Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT04010435
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT04010435
Study Brief:
Protocol Section:
NCT04010435