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出境医 / 临床实验 / Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders

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

Study Description
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.
Study Design
Layout table for study information
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 : May 30, 2021
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
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.
Outcome Measures
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)


Eligibility Criteria
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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.
Contacts and Locations

Contacts
Layout table for location contacts
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
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Vertigo [ Time Frame: 6 months followup ]
    visual vertigo analogue scale
  • Balance and postural stability [ Time Frame: 6 months follow up ]
    Berg balance scale- A
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Postural stability [ Time Frame: 1 month ]
    Computerized dynamic Posturography- Scores ranging zero min score and 100 max score
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019) 		Activities of daily living [ Time Frame: 6 months follow up ]
Vestibular disorders activities of daily living- Dizziness handicapped inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders
Official Title  ICMJE Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Vestibular Disorders
Intervention  ICMJE
  • Device: repetitive transcranial magnetic stimulation
    high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.
  • Device: Galvanic stimulation
    galvanic stimulation of the vestibular apparatus
Study Arms  ICMJE
  • 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.
    Intervention: Device: repetitive transcranial magnetic stimulation
  • 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.
    Intervention: Device: Galvanic stimulation
  • No Intervention: Control (Group C)
    Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2019) 		60
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		45
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reham A.M. Ahmed, Phd 00201285059796 rihamelsayed_pt@hotmail.com
Contact: Hesham M. S. Nafia, M.Sc 00201017713483 drhesham101@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010435
Other Study ID Numbers  ICMJE P.T.REC/012/002202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reham Ali Mohamed Ali Ahmed, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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