Auditory and Vestibular Function in Parkinson's Disease

August 30, 2021 updated by: Mohammed Kamal Sabrah, Assiut University

Auditory and Vestibular Functions in Patients With Parkinson's Disease

The aims of this study are to:

  1. Evaluate peripheral and central auditory and vestibular function in group of adults with idiopathic PD.
  2. Determine the relationship between the presence of significant auditory and vestibular dysfunctions to patients' demographic, clinical (motor and non-motor manifestations) and treatment variables

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease (PD) is a progressive neurodegenerative disease of central nervous system that mainly affects the motor system . The worldwide data showed a rising prevalence of PD with age. Meta-analysis showed a prevalence of 41/100,000 in 40-49 years old; 107/100,000 in 50-59 years; 173/100,000 in 55-64 years; 428/10,000 in 60-69 years; 425/10,000 in 65-74 years; 1087/10,000 in 70-79 years; and 1903/100,000 in >80 years. Some differences in prevalence have been observed in different geographic location and in relation to sex . Patients with PD have multiple non-motor symptoms (NMSs) including fatigue, sensory symptoms, autonomic disturbance. sleep disorders, neuropsychiatric abnormalities etc . In the last decade and even in early stages of PD, studies reported hearing and/or vestibular dysfunctions in patients with PD with an estimated frequency of 25-50% . In the last decade and even in early stages of PD, studies reported vestibular dysfunctions in patients with PD with an estimated frequency of 14-25% compared to 5 -7.4% of the general population matched for age.

The pathophysiologic mechanisms of NMSs with PD are complex. Experimental as well as functional neuroimaging (e.g. SPECT and functional MRI) studies found that outputs from basal ganglia are directed to the inferior colliculus, medial geniculate nucleus, and temporal cortex. Motor or NMSs, occur due to loss not only of dopaminergic neurons in the substantia nigra but also in other dopaminergic and non-dopaminergic areas of the brain including serotoninergic, noradrenergic, and cholinergic systems. Lewy bodies and neurites consisting of α-synuclein, the main pathological features of PD, were observed in brain hemispheres as well as, spinal cord, brainstem nuclei and fiber tracts including vestibular nuclei and efferent neuronal system within the inner ear .

Diagnostic basic audiologic and vestibular evaluation and electrophysiological testing as brainstem auditory evoked potential (BAEP), videonystagmography (VNG) and cervical (cVEMP) and ocular (oVEMP) vestibular evoked myogenic potentials are easily available and applicable in many parts of the world as diagnostic tests to objectively evaluate peripheral and central auditory and vestibular dysfunctions for many disease including PD . This may provide early drug intervention and rehabilitation for patients and improve their qualities of life.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Patients with PD will be recruited from the Department of Neurology and Psychiatry and its out-patient clinic, Assiut University Hospital, Assiut, Egypt.
  • All patients will be encoded to confidentiality.

Description

Inclusion Criteria:

  • Adults with age range 55-65 years old from both gender.
  • Patients have to fulfil the criteria for diagnosis of idiopathic PD [Postuma et al., 2015]. and age, sex and socioeconomic matched healthy subjects recruited from the general population as controls for statistical comparisons.

Exclusion Criteria:

  • - Concomitant medical and metabolic illnesses.
  • Secondary or atypical parkinsonism
  • Evidence of concomitant cerebrovascular stroke temporally related to the onset of the disease.
  • Major psychiatric disorder known to affect cognition.
  • Dementia (i.e. mini mental score examination or MMSE score <24)
  • Major language disturbance
  • MRI brain showing structural lesion
  • Severe known auditory (hearing thresholds >50 dBnHL) or visual impairment affecting their ability to complete testing before participation of the study.
  • Improper neck movements that interfere with assessment.
  • Middle ear diseases, ear infection, ear trauma, or acoustic trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory and vestibular functions in patients with Parkinson's disease
Time Frame: 16 month
1.1 basic audiological evaluation this include otoscopic examination , screening audiogram,stapedial reflex testing 1.2 vestibular evaluation by VNG recording ,VEMP recording ,cVEMP recording ,oVEMP recording
16 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 13, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parkinson

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on VEMP recording

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe