Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12619000182190
Ethics application status
Approved
Date submitted
19/10/2018
Date registered
8/02/2019
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Brain stimulation for the improvement of thinking and memory skills in Mild Cognitive Impairment
Query!
Scientific title
A longitudinal investigation of the neurophysiological changes related to cognitive performance and the effects of neuromodulation in Mild Cognitive Impairment
Query!
Secondary ID [1]
296334
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment
310050
0
Query!
Memory difficulties
310051
0
Query!
Condition category
Condition code
Neurological
308803
308803
0
0
Query!
Other neurological disorders
Query!
Mental Health
308804
308804
0
0
Query!
Studies of normal psychology, cognitive function and behaviour
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Transcranial alternating current stimulation (tACS) involves the application of a weak alternating electrical current to the scalp to non-invasively increase cortical excitability.
A stimulation course of active gamma-tACS at 40Hz will be applied to the left prefrontal cortex at 1mA for 20-minutes per treatment during two Acute Phases (4 weeks) of treatment. Each Acute Phase is separated by a period of 6 months. . This treatment sequence will be repeated each year for a total of three years. Participants will self-administer treatments in their own home following supervised training at the Monash Alfred Psychiatry research centre. Treatment adherence will be monitored using device analytics.
Query!
Intervention code [1]
312700
0
Treatment: Devices
Query!
Comparator / control treatment
A stimulation course of sham gamma-tACS will be applied to the left prefrontal cortex at 1mA. Sham tACS sensations are similar to active tACS but without an active current. Neuropsychosocial outcomes and cognitive performance will be compared pre- and post-tACS across the two groups (active and placebo tACS).
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
307823
0
The primary outcome, cognitive performance, will be assessed using a comprehensive battery of composite neuropsychological tests. These composite outcomes include the TOPF, BVMT, RAVLT, Trail Making Test, forward and backward Digit Span, Verbal Fluency, Stroop, Rey Complex (Copy), Digit Symbol Coding, Rey Complex (delay/recall), BNT.
Query!
Assessment method [1]
307823
0
Query!
Timepoint [1]
307823
0
One week pre-Acute Phase, immediately post-Acute Phase, three months post-acute phase, six months post-Acute Phase, nine months post-Acute Phase and 12-months post Acute Phase (primary endpoint).
Query!
Primary outcome [2]
307824
0
TMS-EEG evoked potential amplitudes will be assessed to measure changes in cortical activity within the prefrontal cortex in response to the tACS treatment.
Query!
Assessment method [2]
307824
0
Query!
Timepoint [2]
307824
0
One week pre-Acute Phase, three months post-acute phase, six months post-Acute Phase, nine months post-Acute Phase and 12-months post Acute Phase (primary endpoint).
Query!
Primary outcome [3]
307825
0
Psycho-social well-being will be assessed using a comprehensive battery of composite self-report questionnaires including the FAQ, Geriatric Depression Scale, CTQ, LEC, PSS, NEO-PI-3, MSPSS, ECR-R, UCLA, and ADRI.
Query!
Assessment method [3]
307825
0
Query!
Timepoint [3]
307825
0
One week pre-Acute Phase and 12-months post-Acute Phase (primary endpoint).
Query!
Secondary outcome [1]
353068
0
Genotypes (DNA) implicated in Alzheimer's Disease will be examined as an exploratory outcome using a blood sample.
Query!
Assessment method [1]
353068
0
Query!
Timepoint [1]
353068
0
Peripheral blood samples will be collected and stored at one week pre-Acute Phase.
Query!
Secondary outcome [2]
353257
0
Epigenetic changes (methylation) and expression of genes (mRNA) will be assessed in a composite manner using a blood sample.
Query!
Assessment method [2]
353257
0
Query!
Timepoint [2]
353257
0
One week pre-Acute Phase each year.
Query!
Eligibility
Key inclusion criteria
(1) Meet criteria for amnestic-Mild Cognitive Impairment as defined by the International working group on mild cognitive impairment; (2) are competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study, as assessed by a clinical staff member independent of the research project; (3) are between the ages of 50 and 70; (4) are able to participate in cognitive testing in English.
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
(1) Have a DSM-IV history of substance abuse or dependence in the last 6 months; (2) have a concomitant major and unstable medical, psychiatric or neurological illness; (3) are pregnant, (4) are currently taking any medication shown to interfere with the effects of stimulation; namely benzodiazepines; or (5) have any contraindications to brain stimulation as assessed using the TMS/tACS safety screen.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Device condition is coded; central randomisation by computer.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
The study is primarily powered to detect a significant improvement in cognitive function following tACS. Single sessions of transcranial electrical stimulation have been shown to have a moderate effect size on cognition (Cohen’s d = 0.50) in older adults. Therefore, in the proposed study we are predicting that repeated sessions of tACS will result in at least a moderate to large effect size (d = 0.60); using this effect size a sample of 100 will provide greater than 95% power with an alpha of 0.05.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
22/11/2018
Query!
Date of last participant enrolment
Anticipated
22/02/2030
Query!
Actual
Query!
Date of last data collection
Anticipated
30/11/2033
Query!
Actual
Query!
Sample size
Target
100
Query!
Accrual to date
1
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
12205
0
The Alfred - Prahran
Query!
Recruitment hospital [2]
12373
0
Epworth Rehabilitation Camberwell - Camberwell
Query!
Recruitment postcode(s) [1]
24380
0
3004 - Prahran
Query!
Recruitment postcode(s) [2]
24381
0
3004 - St Kilda Road Melbourne
Query!
Recruitment postcode(s) [3]
24636
0
3124 - Camberwell
Query!
Funding & Sponsors
Funding source category [1]
300938
0
University
Query!
Name [1]
300938
0
Monash University
Query!
Address [1]
300938
0
Monash University
Wellington Rd, Clayton, VIC 3800
Query!
Country [1]
300938
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Monash University
Query!
Address
Wellington Rd, Clayton, VIC 3800
Query!
Country
Australia
Query!
Secondary sponsor category [1]
300551
0
None
Query!
Name [1]
300551
0
Nil
Query!
Address [1]
300551
0
Nil
Query!
Country [1]
300551
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
301705
0
Alfred Hospital Ethics Committee
Query!
Ethics committee address [1]
301705
0
The Alfred Hospital
55 Commercial Rd, Melbourne, VIC 3004
Query!
Ethics committee country [1]
301705
0
Australia
Query!
Date submitted for ethics approval [1]
301705
0
31/05/2018
Query!
Approval date [1]
301705
0
13/08/2018
Query!
Ethics approval number [1]
301705
0
274/18
Query!
Summary
Brief summary
There are many factors which are thought to contribute to the ability to maintain good brain health, including genetics, psychosocial and environmental factors. In addition, recent research has indicated that it may be possible to induce, or promote, brain health using non-invasive brain stimulation - namely transcranial Alternating Current Stimulation (tACS).
Therefore, the purpose of this project is to investigate brain activity that is related to cognitive performance (i.e. thinking skills) in people with mild cognitive impairment. We will conduct these investigations a number of times over a three-year period to allow us to look at any changes that may occur in brain activity and cognitive performance. We will also be looking at any psychosocial and environmental factors that might contribute to changes in brain activity and cognitive performance. Finally, we will also investigate the effects of tACS on brain activity and cognition over the same period of time. Overall, this project aims to help provide a better understanding of the reasons why some people with MCI go on to develop Alzheimer’s, whilst others do not, and ultimately help in the development of early intervention treatments for Alzheimer’s disease.
It is hypothesised that participants receiving active treatment will improve cognitive function, enhance brain activity, and strengthen functional brain connectivity after each yearly treatment course compared to those who undergo sham treatment. It is also hypothesised that there will be a lower conversion from MCI to Alzheimer’s disease in individuals receiving the active treatment over the three-year period, compared to those receiving the sham treatment. Finally, it is hypothesised that biopsychosocial factors will influence pathophysiological changes in people with MCI over time.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
87826
0
A/Prof Kate Hoy
Query!
Address
87826
0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne 3004
VIC
Epworth Centre for Innovation in Mental Health (ECIMH)
888 Toorak Rd
Melbourne 3124
VIC
Query!
Country
87826
0
Australia
Query!
Phone
87826
0
+61 3 9076 5034
Query!
Fax
87826
0
Query!
Email
87826
0
[email protected]
Query!
Contact person for public queries
Name
87827
0
Ms Freya Stockman
Query!
Address
87827
0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne 3004
VIC
Epworth Centre for Innovation in Mental Health (ECIMH)
888 Toorak Rd
Melbourne 3124
VIC
Query!
Country
87827
0
Australia
Query!
Phone
87827
0
+61 3 9076 9896
Query!
Fax
87827
0
Query!
Email
87827
0
[email protected]
Query!
Contact person for scientific queries
Name
87828
0
A/Prof Kate Hoy
Query!
Address
87828
0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne 3004
VIC
Epworth Centre for Innovation in Mental Health (ECIMH)
888 Toorak Rd
Melbourne 3124
VIC
Query!
Country
87828
0
Australia
Query!
Phone
87828
0
+61 3 9076 5034
Query!
Fax
87828
0
Query!
Email
87828
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Individual participant data will not become available to other researchers.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4104
Plain language summary
No
Data has not yet been analysed
Documents added automatically
No additional documents have been identified.
Download to PDF