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

NCT05871385 | Completed

• 1 other identifier: P.T.REC/012/002202
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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

Conditions

Peripheral Vestibular Disorders

Outcome Measures

Primary Outcomes (2)

• Postural stability

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

  change from baseline to 8 weeks after intervention

• Visual Vertigo Analogue Scale

  Indicate the amount of dizziness you experience in different situations

  change from baseline to 8 weeks after intervention

Secondary Outcomes (1)

• Berg balance scale

  change from baseline to 8 weeks after intervention

Study Arms (2)

Group A (r TMS group)

EXPERIMENTAL

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. Device: repetitive transcranial magnetic stimulation high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.

Device: rTMS group

Control (Group B) (placebo rTMS)

PLACEBO COMPARATOR

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

Device: placebo rTMS group

Interventions

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

Also known as: repetitive transcranial magnetic stimulation

Group A (r TMS group)

placebo rTMS group DEVICE

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

Also known as: placebo rTMS

Control (Group B) (placebo rTMS)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead
• Cairo University: collaborator

Study Sites (2)

Cairo University Hospitals

Cairo, Egypt

Location

faculty of medicine , Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at faculty of physical therapy

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 23, 2023
• Study Start: April 23, 2023
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

EG (2)