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

Peripheral Vestibular Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871385
• Other study ID #: P.T.REC/012/002202
• Status: Completed
• Phase: N/A
• Start date: April 23, 2023
• Est. completion date: December 27, 2023

Study information

• Verified date: March 2024
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diagnosis with peripheral vestibular disorders from audiologist or neurologist.

2. The patient's age will be ranged from forty to sixty five 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.

Related Conditions & MeSH terms

• Dizziness
• Peripheral Vestibular Disorders
• Vestibular Diseases

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo
Egypt	faculty of medicine , Cairo University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural stability	Computerized dynamic Posturography- Scores ranging zero min score and 100 max score	change from baseline to 8 weeks after intervention
Secondary	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	change from baseline to 8 weeks after intervention