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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010435
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Reham Ali Mohamed Ali Ahmed, Cairo University

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.

Condition or disease Intervention/treatment Phase
Peripheral Vestibular Disorders Device: repetitive transcranial magnetic stimulation Device: Galvanic stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Active Comparator: Group A (r TMS group)
Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises.
Device: repetitive transcranial magnetic stimulation
high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.

Active Comparator: Group B (Galvanic stimulation)
Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo galvanic vestibular stimulation; in addition to designed vestibular rehabilitation exercises.
Device: Galvanic stimulation
galvanic stimulation of the vestibular apparatus

No Intervention: Control (Group C)
Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises.



Primary Outcome Measures :
  1. Vestibular canal weakness [ Time Frame: 1 mounth ]
    Videonystagmography- Scores ranging zero min score and 100 max score

  2. 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 Outcome Measures :
  1. Postural stability [ Time Frame: 1 month ]
    Computerized dynamic Posturography- Scores ranging zero min score and 100 max score

  2. Balance [ Time Frame: 1 month ]
    Berg balance scale - 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56

  3. Vestibular disorders activities of daily living [ Time Frame: 1 month ]
    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)



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010435


Contacts
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Contact: Reham A.M. Ahmed, Phd 00201285059796 rihamelsayed_pt@hotmail.com
Contact: Hesham M. S. Nafia, M.Sc 00201017713483 drhesham101@gmail.com

Locations
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Egypt
Cairo university Recruiting
Cairo, Giza, Egypt, 12613
Contact: Reham A.M. Ahmed, phd    00201285059796    rihamelsayed_pt@hotmail.com   
Sponsors and Collaborators
Cairo University
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Responsible Party: Reham Ali Mohamed Ali Ahmed, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT04010435    
Other Study ID Numbers: P.T.REC/012/002202
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vestibular Diseases
Ear Diseases
Labyrinth Diseases
Otorhinolaryngologic Diseases