Auditory and Vestibular Function in Parkinson's Disease
1 other identifier
observational
70
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedStudy Start
First participant enrolled
August 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedSeptember 5, 2021
August 1, 2021
4 months
August 9, 2021
August 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Auditory and vestibular functions in patients with Parkinson's disease
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
Interventions
* Clinical evaluation: All participants will undergo detailed medical and neurological histories and examinations. * The severity of manifestations of PD will be assessed using the Movement Disorder Society (MDS)-sponsored new version of Unified PD Rating Scale (MDS-UPDRS).
Eligibility Criteria
* 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.
You may qualify if:
- 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.
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Smith PF. Vestibular Functions and Parkinson's Disease. Front Neurol. 2018 Dec 11;9:1085. doi: 10.3389/fneur.2018.01085. eCollection 2018.
PMID: 30619045BACKGROUNDScarpa A, Cassandro C, Vitale C, Ralli M, Policastro A, Barone P, Cassandro E, Pellecchia MT. A comparison of auditory and vestibular dysfunction in Parkinson's disease and Multiple System Atrophy. Parkinsonism Relat Disord. 2020 Feb;71:51-57. doi: 10.1016/j.parkreldis.2020.01.018. Epub 2020 Jan 30.
PMID: 32032926BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
August 9, 2021
First Posted
September 5, 2021
Study Start
August 13, 2023
Primary Completion
December 1, 2023
Study Completion
April 1, 2024
Last Updated
September 5, 2021
Record last verified: 2021-08