Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders

Peripheral Vestibular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04010435
• Other study ID #: P.T.REC/012/002202
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Reham A.M. Ahmed, Phd
• Phone: 00201285059796
• Email: rihamelsayed_pt[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ear Diseases
• Peripheral Vestibular Disorders
• Vestibular Diseases

Intervention

Device:
• repetitive transcranial magnetic stimulation
high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.
• Galvanic stimulation
galvanic stimulation of the vestibular apparatus

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vestibular canal weakness	Videonystagmography- Scores ranging zero min score and 100 max score	1 mounth
Primary	Dizziness handicapped inventory	identify difficulties that you may be experiencing because of your dizziness- 25 items with max score 100 and min score zero	1 month
Secondary	Postural stability	Computerized dynamic Posturography- Scores ranging zero min score and 100 max score	1 month
Secondary	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	1 month
Secondary	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)	1 month