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

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Vestibular Disorders
• Intervention / Treatment: Device: rTMS group; Device: placebo rTMS group

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Hospitals
  • Cairo, Egypt
    • faculty of medicine , Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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; Other Names: repetitive transcranial magnetic stimulation
Placebo Comparator: Control (Group B) (placebo rTMS); Twenty eight randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.	Device: placebo rTMS group; Twenty eight randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.; Other Names: placebo rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2023
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: April 22, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Labyrinth Diseases; Vestibular Diseases; Dizziness
• Other Study ID Numbers: P.T.REC/012/002202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No