Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001052628
Ethics application status
Approved
Date submitted
18/09/2014
Date registered
2/10/2014
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Date results information initially provided
26/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain stimulation, aging and cognition: Investigating neuroplasticity and cognitive enhancement following brain stimulation in healthy ageing and amnestic mild cognitive impairment.
Scientific title
Effect of transcranial direct current stimulation on neuroplasticity and cognitive performance in younger adults, older adults and adults with amnestic mild cognitive impairment
Secondary ID [1] 285366 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 293093 0
Aging 293094 0
Cognitive performance in healthy younger adults 293095 0
Condition category
Condition code
Mental Health 293368 293368 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 293369 293369 0 0
Studies of the normal brain and nervous system
Neurological 293444 293444 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation (tDCS) involves the application of a weak electric current to the scalp to non-invasively increase cortical excitability.

Anodal transcranial direct current stimulation (tDCS) at 1mA intensity will be applied to the left dorsolateral prefrontal cortex (LDLPFC) for 20 minutes in a single session.
Intervention code [1] 290280 0
Treatment: Devices
Comparator / control treatment
Performance will be compared pre- and post-tDCS across the three groups (younger adults, older adults and adults with a-MCI)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293194 0
N-back task (accuracy and reaction time)
Timepoint [1] 293194 0
30 minutes post-stimulation
Primary outcome [2] 293195 0
TMS-EEG evoked potential amplitudes
Timepoint [2] 293195 0
5 and 20 minutes post-stimulation
Secondary outcome [1] 310559 0
EEG oscillations
Timepoint [1] 310559 0
5 and 20 minutes post-stimulation

Eligibility
Key inclusion criteria
a) Diagnosis of amnestic mild cognitive impairment (56 - 75 years) OR
b) Healthy adults aged between 18 - 35 years OR 56 - 75 years with no cognitive complaints.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of seizures or neurological disorders
* Current psychiatric diagnoses, alcohol or substance dependence
* Left-handed
* Presence of metal in head
* Women who are currently pregnant or lactating
* Individuals taking benzodiazepines or acetyl cholinesterase inhibitors

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/10/2014
Actual
13/11/2014
Date of last participant enrolment
Anticipated
Actual
19/08/2016
Date of last data collection
Anticipated
Actual
19/08/2016
Sample size
Target
60
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289979 0
University
Name [1] 289979 0
Monash University
Country [1] 289979 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton
VIC 3800
Country
Australia
Secondary sponsor category [1] 288665 0
None
Name [1] 288665 0
Address [1] 288665 0
Country [1] 288665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291689 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 291689 0
Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 291689 0
Australia
Date submitted for ethics approval [1] 291689 0
Approval date [1] 291689 0
12/08/2014
Ethics approval number [1] 291689 0

Summary
Brief summary
Amnestic mild cognitive impairment (a-MCI) is believed to represent a transition period between normal aging and Alzheimer's disease. People with a-MCI experience problems with their memory without it impacting on their daily functioning. As a-MCI represents a stage prior to irreversible neurodegeneration, it is important from a therapeutic perspective that neural changes occurring in a-MCI are determined in order to see if there remains potential for response to treatment.

Neuroplasticity refers to the brains ability to re-organize its function in response to the environment. One aspect of this is known as long-term potentiation (LTP), which is imperative in learning and memory. LTP-like plasticity can be induced through brain stimulation techniques including transcranial direct current stimulation (tDCS). Application of tDCS through a gentle electrical current can increase brain activity as measured through electroencephalography (EEG) and behavioural outcomes. When transcranial magnetic stimulation (TMS) is applied in combination with EEG, the cortical excitability of the stimulated and surrounding brain regions can be determined. This provides information about the LTP-like plasticity that is present. Together with cognitive performance, this information can help to determine the changes occurring in a-MCI compared to younger and older adults, and the relationships between plasticity and cognition.

The aim of our study is to investigate whether LTP can be induced in a-MCI and if there are differences in LTP-like plasticity compared to younger and older healthy adults, and the relationship of plasticity to cognitive performance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51226 0
Ms Melanie Emonson
Address 51226 0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne 3004
VIC
Country 51226 0
Australia
Phone 51226 0
+61 3 9076 9823
Fax 51226 0
Email 51226 0
[email protected]
Contact person for public queries
Name 51227 0
Ms Melanie Emonson
Address 51227 0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne 3004
VIC
Country 51227 0
Australia
Phone 51227 0
+61 3 9076 9823
Fax 51227 0
Email 51227 0
[email protected]
Contact person for scientific queries
Name 51228 0
Ms Melanie Emonson
Address 51228 0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne 3004
VIC
Country 51228 0
Australia
Phone 51228 0
+61 3 9076 9823
Fax 51228 0
Email 51228 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Emonson, M. R. L., Fitzgerald, P. B., Rogasch, N. ... [More Details]

Documents added automatically
No additional documents have been identified.