Parkinson DiseaseNCT05034094
Auditory and Vestibular Function in Parkinson's Disease
An observational study of Parkinson Disease, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- VEMP recording
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- - 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Auditory and Vestibular Functions in Patients With Parkinson's Disease
The aims of this study are to:
- Evaluate peripheral and central auditory and vestibular function in group of adults with idiopathic PD.
- Determine the relationship between the presence of significant auditory and vestibular dysfunctions to patients' demographic, clinical (motor and non-motor manifestations) and treatment variables
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- VEMP recording
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEMP recordingOther
- 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start13 Aug 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Kamal Sabrah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034094
- Sponsor's protocol ID
- parkinson
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith PF. Vestibular Functions and Parkinson's Disease. Front Neurol. 2018 Dec 11;9:1085. doi: 10.3389/fneur.2018.01085. eCollection 2018.
PubMed 30619045Scarpa 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.
PubMed 32032926
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory and Vestibular Functions in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05034094
- Acronym / sponsor ID
- parkinson
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 13 Aug 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are to:
- Evaluate peripheral and central auditory and vestibular function in group of adults with idiopathic PD.
- Determine the relationship between the presence of significant auditory and vestibular dysfunctions to patients' demographic, clinical (motor and non-motor manifestations) and treatment variables
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEMP recording* 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). | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 30619045Smith PF. Vestibular Functions and Parkinson's Disease. Front Neurol. 2018 Dec 11;9:1085. doi: 10.3389/fneur.2018.01085. eCollection 2018.
- Background: PubMed 32032926Scarpa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed kamal, master (01010110373, bdewimo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory and vestibular functions in patients with Parkinson's disease (time frame: 16 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034094, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.