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rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients/ Chronic Labyrinthitis (rTMS)

Primary Purpose

Peripheral Vestibular Disorders

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
rTMS group
placebo rTMS group
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vestibular Disorders

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis with peripheral vestibular disorders from audiologist or neurologist. The patient's age will be ranged from forty to sixty five 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: 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). Alcohol abuse. Epilepsy.

Sites / Locations

  • Cairo University Hospitals
  • faculty of medicine , Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A (r TMS group)

Control (Group B) (placebo rTMS)

Arm Description

Twenty five randomly assigned patients with 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.

Twenty five randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.

Outcomes

Primary Outcome Measures

Postural stability
Computerized dynamic Posturography- Scores ranging zero min score and 100 max score

Secondary Outcome Measures

Berg balance scale
Balance 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56

Full Information

First Posted
April 22, 2023
Last Updated
August 27, 2023
Sponsor
Beni-Suef University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05871385
Brief Title
rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients/ Chronic Labyrinthitis
Acronym
rTMS
Official Title
rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients, Double Blinded RCT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2023 (Actual)
Primary Completion Date
August 27, 2023 (Actual)
Study Completion Date
August 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Falling is one of the most common consequences of vestibular dizziness. Most of patients with vestibular dysfunction suffer from balance disorders, postural instability and vertigo that may lead to life threating complications as fractures and brain injuries. 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. To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) added to supervised vestibular rehabilitation program on balance and postural stability in patients with vestibular dizziness
Detailed Description
The subjects of both genders with age 40 to 65 will be allocated randomly into two equal groups A and B. Group A Outcomes measure will include : Berg balance scale, computerized dynamic posturography (CDP) . Assessment will be done before and after treatment sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vestibular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (r TMS group)
Arm Type
Experimental
Arm Description
Twenty five randomly assigned patients with 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.
Arm Title
Control (Group B) (placebo rTMS)
Arm Type
Placebo Comparator
Arm Description
Twenty five randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.
Intervention Type
Device
Intervention Name(s)
rTMS group
Other Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
Twenty five randomly assigned patients with 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 Type
Device
Intervention Name(s)
placebo rTMS group
Other Intervention Name(s)
placebo rTMS
Intervention Description
Twenty five randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.
Primary Outcome Measure Information:
Title
Postural stability
Description
Computerized dynamic Posturography- Scores ranging zero min score and 100 max score
Time Frame
change from baseline to 8 weeks after intervention
Secondary Outcome Measure Information:
Title
Berg balance scale
Description
Balance 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56
Time Frame
change from baseline to 8 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis with peripheral vestibular disorders from audiologist or neurologist. The patient's age will be ranged from forty to sixty five 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: 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). Alcohol abuse. Epilepsy.
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
Country
Egypt
Facility Name
faculty of medicine , Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients/ Chronic Labyrinthitis

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