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

Primary Purpose

Peripheral Vestibular Disorders

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

repetitive transcranial magnetic stimulation

Galvanic stimulation

About this trial

This is an interventional treatment trial for Peripheral Vestibular Disorders

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Group A (r TMS group)

Group B (Galvanic stimulation)

Control (Group C)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Vestibular canal weakness

Videonystagmography- Scores ranging zero min score and 100 max score

Dizziness handicapped inventory

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

Secondary Outcome Measures

Postural stability

Computerized dynamic Posturography- Scores ranging zero min score and 100 max score

Balance

Berg balance scale - 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56

Vestibular disorders activities of daily living

The Vestibular Disorders Activities of Daily Living (VADL) scale assesses the impact of vestibular impairment on everyday activities. The 28 items are grouped into three dimensions: functional (self-care and intimate activities), ambulation (walking and stair climbing), and instrumental (home management and leisure activities).Each item is rated with zero (min score) to 10 (max score)

Full Information

NCT ID

NCT04010435

First Posted

July 3, 2019

Last Updated

September 5, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04010435

Brief Title

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

Official Title

Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

A pilot study has been recruited to calculate sample size and determine rTMs protocol that will be utilized during the study were two protocols has been compared and according to pilot study results collaborated with literature review a established protocol has been utilized. The subjects of both genders with age 30 to 60 will be allocated randomly into three equal groups A, B and C. Group A Outcomes measure will include : VNG (videonystagmography), Dizziness handicapped inventory, Berg balance scale, Vestibular disorders activities of daily living scale(VADL). Assessment will be done before and after treatment sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vestibular Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A (r TMS group)

Arm Type

Active Comparator

Arm Description

Arm Title

Group B (Galvanic stimulation)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control (Group C)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

repetitive transcranial magnetic stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Galvanic stimulation

Intervention Description

galvanic stimulation of the vestibular apparatus

Primary Outcome Measure Information:

Title

Vestibular canal weakness

Description

Videonystagmography- Scores ranging zero min score and 100 max score

Time Frame

1 mounth

Title

Dizziness handicapped inventory

Description

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

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Postural stability

Description

Computerized dynamic Posturography- Scores ranging zero min score and 100 max score

Time Frame

1 month

Title

Balance

Description

Berg balance scale - 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56

Time Frame

1 month

Title

Vestibular disorders activities of daily living

Description

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Reham A.M. Ahmed, Phd

Phone

00201285059796

rihamelsayed_pt@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hesham M. S. Nafia, M.Sc

Phone

00201017713483

drhesham101@gmail.com

Facility Information:

Facility Name

Cairo university

City

Cairo

State/Province

Giza

ZIP/Postal Code

12613

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Reham A.M. Ahmed, phd

Phone

00201285059796

rihamelsayed_pt@hotmail.com

12. IPD Sharing Statement

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

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