NCT05034094

Brief Summary

The aims of this study are to:

  1. 1.Evaluate peripheral and central auditory and vestibular function in group of adults with idiopathic PD.
  2. 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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

August 9, 2021

Last Update Submit

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

Age55 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsold age
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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: 30619045BACKGROUND
  • Scarpa 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

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Mohamed kamal, master

CONTACT

sherifa hamed, professor

CONTACT

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