Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders

NCT04010435 | Recruiting

• 1 other identifier: P.T.REC/012/002202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Vestibular disorders are disabling conditions that can have a major effect on functioning especially on daily activities and social participation. Latest epidemiological studies estimate that as many as 35% of adults aged 40 years or older had experienced some form of vestibular dysfunction. 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. The purpose of this study is to compare between rTMs stimulation and galvanic vestibular stimulation in patients with unilateral peripheral vestibular disorders.

Conditions

Peripheral Vestibular Disorders

Outcome Measures

Primary Outcomes (2)

• Vestibular canal weakness

  Videonystagmography- Scores ranging zero min score and 100 max score

  1 mounth

• Dizziness handicapped inventory

  identify difficulties that you may be experiencing because of your dizziness- 25 items with max score 100 and min score zero

  1 month

Secondary Outcomes (3)

• Postural stability

  1 month

• Balance

  1 month

• Vestibular disorders activities of daily living

  1 month

Study Arms (3)

Group A (r TMS group)

ACTIVE COMPARATOR

Twenty randomly assigned patients with unilateral 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

Group B (Galvanic stimulation)

ACTIVE COMPARATOR

Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo galvanic vestibular stimulation; in addition to designed vestibular rehabilitation exercises.

Device: Galvanic stimulation

Control (Group C)

NO INTERVENTION

Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises.

Interventions

repetitive transcranial magnetic stimulation DEVICE

high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.

Group A (r TMS group)

Galvanic stimulation DEVICE

galvanic stimulation of the vestibular apparatus

Group B (Galvanic stimulation)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Definite diagnosis with unilateral peripheral vestibular disorders from audiologist or neurologist.
• The patient's age will be ranged from thirty to sixty 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:

• Benign positional vertigo.
• 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

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Giza Governorate, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Reham A.M. Ahmed, Phd

CONTACT

00201285059796; rihamelsayed_pt@hotmail.com

Hesham M. S. Nafia, M.Sc

CONTACT

00201017713483; drhesham101@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: February 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

EG (1)