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Completed

NCT Number: NCT05871385

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

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

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Key information

Conditions

Peripheral Vestibular Disorders

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals, Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis with peripheral vestibular disorders from audiologist or neurologist.
  • The patient's age will be ranged from forty five to seventy 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.

Treatment and study plan

rTMS group

Device

Twenty eight 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

Other names: repetitive transcranial magnetic stimulation

placebo rTMS group

Device

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

Other names: placebo rTMS

Primary outcomes

  1. Postural stability

    Time frame: change from baseline to 8 weeks after intervention

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

  2. Visual Vertigo Analogue Scale

    Time frame: change from baseline to 8 weeks after intervention

    Indicate the amount of dizziness you experience in different situations

Secondary outcomes

  1. Berg balance scale

    Time frame: change from baseline to 8 weeks after intervention

    Balance

    • 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • Cairo University

Registry information

Official study title

rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients, Double Blinded RCT

Acronym: rTMS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 23, 2023
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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