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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623000285651
Ethics application status
Approved
Date submitted
6/03/2023
Date registered
16/03/2023
Date last updated
31/08/2023
Date data sharing statement initially provided
16/03/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Quantifying stimulus evoked electroencephalographic variability in mild dementia
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Scientific title
A pilot study designed to compare differences in stimulus evoked electroencephalographic variability between participants assessed to be cognitively normal and participants diagnosed with mild dementia
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Secondary ID [1]
309135
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Nil known
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Universal Trial Number (UTN)
U1111-1289-3730
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Trial acronym
EEGVID
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Alzheimer's Disease
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Condition category
Condition code
Neurological
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0
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Dementias
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Neurological
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0
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Alzheimer's disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Twenty four participants diagnosed with mild dementia due to possible or probable Alzheimer's disease (MDAD), and 24 age matched controls (CN), will be recruited through a Cognitive Dementia and Memory Service (CADMS) Clinic.
All participants will have their time locked, 64 channel electroencephalogram (EEG), recorded in response to three simple cognitive tasks delivered by a laptop computer connected to headphones: an active visual semantic priming task, a passive visual memory repetition priming task and an active three level auditory oddball task. The active visual semantic priming task requires participants to indicate via button press whether a sequential pair of briefly presented images are semantically related. The passive visual memory repetition task involves the participant viewing a sequence of images that may be novel or repeated once or twice. The active three level auditory oddball task requires participants to listen to a sequence of randomly presented tones (drawn from one of three frequencies) and to indicate via button press when a defined target tone is heard.
EEG recordings will be performed by trained research staff. Tasks will be run consecutively in random order, with 2 minutes each of eyes-closed and eyes-open resting EEG recorded at the beginning of the testing session. The total testing time will be approximately 60 minutes.
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Intervention code [1]
325582
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Diagnosis / Prognosis
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Intervention code [2]
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Early Detection / Screening
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Comparator / control treatment
24 participants clinically assessed by a Neuropsychiatrist to be cognitively normal (CN group)
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Control group
Active
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Outcomes
Primary outcome [1]
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Time course of time locked changes in evoked EEG variability during the visual semantic priming task
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Assessment method [1]
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Timepoint [1]
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During the single EEG recording session
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Primary outcome [2]
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Time course of time locked changes in evoked EEG variability during the passive visual memory repetition priming task
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Assessment method [2]
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Timepoint [2]
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During the single EEG recording session
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Primary outcome [3]
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Time course of time locked changes in evoked EEG variability during the active three level auditory oddball task
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Assessment method [3]
334126
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Timepoint [3]
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During the single EEG recording session
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Secondary outcome [1]
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Eyes-open resting state EEG band powers
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Assessment method [1]
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Timepoint [1]
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During the single EEG recording session
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Secondary outcome [2]
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Eyes-closed resting state EEG band powers
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Assessment method [2]
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Timepoint [2]
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During the single EEG recording session
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Eligibility
Key inclusion criteria
Male and female participants 60 years or older
English speaking and basic levels of literacy in order to be able to give informed consent and to follow all instructions
Normal or corrected hearing and vision
CN group: Formally assessed to be cognitively normal by CADMS Neuropsychiatrist
MDAD group: Formal diagnosis by CADMS Neuropsychiatrist of possible or probable Alzheimer's Disease; Mild dementia as defined by Clinical Dementia Rating score of 0.5 - 1, Global Deterioration Scale score of 4, and Min-mental Status Examination score of 18 - 23
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Colour blindness
Any history of illness affecting cognitive function e.g., vitamin B12 deficiency, hypothyroidism, significant psychiatric disorders (such as major depression or schizophrenia), neurodegenerative disorders, ischaemic stroke, epilepsy, brain tumour, significant head trauma
Any episodes of unexplained loss of consciousness
History of substance or alcohol abuse
Taking an acetylcholinesterase inhibitor, or any other agent demonstrated to affect cognitive function, within the last 3 months
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/04/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
48
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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St Vincent's Hospital Melbourne
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Address [1]
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41 Victoria Parade
Fitzroy VIC 3065
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Melbourne
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Address
41 Victoria Parade
Fitzroy VIC 3065
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
315082
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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St Vincent's Hospital Melbourne HREC
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Ethics committee address [1]
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St Vincent's Hospital Melbourne HREC
Research Governance Unit
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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02/11/2022
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Approval date [1]
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13/12/2022
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Ethics approval number [1]
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St Vincent's HREC Ref: 240/22
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Summary
Brief summary
The study will assess a potential new method for the early detection of changes in brain function, referred to as Brain Function Fingerprinting or BFF. BFF involves the recording of brain waves (electroencephalogram or EEG) in response to sequences of simple visual or auditory stimuli and analysing the variability of their response. Changes in the variability of the response are hypothesised to indicate changes in brain function. We wish to test the hypothesis that BFF can detect differences between cognitively normal participants and participants suffering from mild dementia due to possible or probable Alzheimer’s Disease.
The study will aim to recruit, over 12 months, a maximum of 24 participants suffering from mild dementia due to possible or probable Alzheimer’s Disease, and 24 of their cognitively normal partners, from the St George’s Hospital. The partners' cognitively normal status will be confirmed by comprehensive clinical evaluation.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Patrick O'Brien
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Address
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Department of Neurology/Clinical Neurosciences
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
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Country
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Australia
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Phone
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+61 3 9231 8577
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Patrick O'Brien
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Address
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Department of Neurology/Clinical Neurosciences
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
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Country
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Australia
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Phone
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+61 3 9231 8577
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Patrick O'Brien
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Address
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Department of Neurology/Clinical Neurosciences
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
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Country
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Australia
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Phone
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+61 3 9231 8577
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Fax
125092
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results only
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When will data be available (start and end dates)?
Available after main trial publication with no end date determined
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Available to whom?
Only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
Any purpose
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How or where can data be obtained?
Dr Patrick O'Brien, Principal Investigator,
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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