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Clinical Trials/NCT04010435
NCT04010435
Recruiting
Not Applicable

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

Cairo University1 site in 1 country60 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Vestibular Disorders
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Vestibular canal weakness
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reham Ali Mohamed Ali Ahmed

Assistant Lecturer

Cairo University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Postural stability(1 month)
  • Balance(1 month)
  • Vestibular disorders activities of daily living(1 month)

Study Sites (1)

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