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

NCT ID: NCT05871385

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-23
• Study Completion Date: 2023-12-27

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.

Conditions

Peripheral Vestibular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (r TMS group)

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.

Group Type: EXPERIMENTAL

rTMS group

Intervention Type: 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

Control (Group B) (placebo rTMS)

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

Group Type: PLACEBO_COMPARATOR

placebo rTMS group

Intervention Type: DEVICE

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

Interventions

rTMS group

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

Intervention Type: DEVICE

placebo rTMS group

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

Intervention Type: DEVICE

Other Intervention Names

repetitive transcranial magnetic stimulation; placebo rTMS

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samir Abdelkhalik Youssef

lecturer at faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University Hospitals

Cairo, , Egypt

faculty of medicine , Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002202

Identifier Type: -

Identifier Source: org_study_id