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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05871385
Acronym
rTMS
Enrollment
56
Registered
2023-05-23
Start date
2023-04-23
Completion date
2023-12-27
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vestibular Disorders

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.

Interventions

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

DEVICEplacebo rTMS group

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

Sponsors

Cairo University
CollaboratorOTHER
Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosis with peripheral vestibular disorders from audiologist or neurologist. 2. The patient's age will be ranged from forty five to seventy 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. Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome PICA). 2. Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency VBI). 3. Previous surgery of the ear. 4. Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness. 5. Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension \>190/110…). 6. Pacemaker or other implanted electrically sensitive device. 7. Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests). 8. Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression….). 9. Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic). 10. Alcohol abuse. 11. Epilepsy.

Design outcomes

Primary

MeasureTime frameDescription
Postural stabilitychange from baseline to 8 weeks after interventionComputerized dynamic Posturography- Scores ranging zero min score and 100 max score
Visual Vertigo Analogue Scalechange from baseline to 8 weeks after interventionIndicate the amount of dizziness you experience in different situations

Secondary

MeasureTime frameDescription
Berg balance scalechange from baseline to 8 weeks after interventionBalance * 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026