Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000906459
Ethics application status
Approved
Date submitted
1/07/2016
Date registered
8/07/2016
Date last updated
13/10/2020
Date data sharing statement initially provided
13/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can transcranial direct current stimulation enhance cognition in older adults?
Scientific title
Can transcranial direct current stimulation enhance cognition in older adults?
Secondary ID [1] 289585 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition and ageing 299340 0
Condition category
Condition code
Mental Health 299326 299326 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
tDCS involves the application of a very weak electrical current applied using two surface electrodes (anode and cathode) to the scalp. tDCS has been shown to alter the excitability of brain cells by shifting their membrane potentials in a de- or hyperpolarising direction; thus making the brain cells more or less likely to fire. Stimulation of brain cells under the anode appears to increase brain activity whereas stimulation under the cathode generally has the opposite effect. Stimulation will be delivered using the StarStim system which allows for programming of active and sham tDCS. Active tDCS will be delivered using standard EEG size electrodes placed within the Starstim system cap. The anode, or activating, electrode will be placed over F3 according to the 10-20 international system for EEG placement, which has been determined to be an accurate estimate of the left DLPFC. The cathodal, or reference, electrode will be placed over the right supraorbital space. Stimulation will be applied at 0.0057 ma/cm for 20mins. Each 20 minute stimulation will be separated by an hour break and a total of sixteen stimulation sessions will be completed within a 2 week period (Monday to Friday). Participants will receive a maximum of two 20 minute stimulation sessions within 24 hours. A/Prof Kate Hoy determines the scheduling of the sessions over the two week period according to her experience and expertise developed through 13 years of co-ordinating brain stimulation clinical trails of this nature.
Intervention code [1] 295189 0
Treatment: Devices
Comparator / control treatment
Sham (placebo) tDCS is achieved by switching off stimulation after approx. 30s; which occurs within the software of the Starstim system allowing for administrator and participant blinding. There is no evidence that 30 seconds of tDCS induces any changes in the brain. The provision of stimulation for 30 seconds allows participants to experience the initial physical sensations of tDCS, which typically fade after 30seconds, thus providing a robust sham. This is a standard method of blinding for tDCS.
Control group
Placebo

Outcomes
Primary outcome [1] 298807 0
level of cognitive impairment will be assessed using the Mini Mental State Examination (MMSE)
Timepoint [1] 298807 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Primary outcome [2] 298812 0
The Global Deterioration Scale (GDS) will be used to gauge the stage of cognitive decline of participants. It is a tool used to assess level of cognitive impairment in dementia and is separated into 7 stages. Stages 1-3 are pre-dementia and stages 4-7 are the dementia stages.
Timepoint [2] 298812 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Primary outcome [3] 298813 0
The Functional Activities Questionnaire (FAQ) will be used to determine cognitive decline ine level of ability to carry out everyday tasks such as paying bills, keeping track of current events or shopping alone.
Timepoint [3] 298813 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [1] 325280 0
TMS-EEG data:

TMS-EEG is performed by stimulating the scalp over the DLPFC while simultaneously recording brain activity via surrounding EEG electrodes. The TMS pulse produces a neurophysiological response in the underlying cortex, referred to as a TMS evoked potential (TEP), which is recorded on EEG and the TEP amplitude gives an index of cortical excitability.
Timepoint [1] 325280 0
baseline and endpoint (i.e. pre and post 16 sessions of tDCS stimulation)
Secondary outcome [2] 325334 0
episodic memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT)
Timepoint [2] 325334 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [3] 325335 0
Episodic memory will be assessed using the Brief Visuospatial Memory Test (BVMT-R)
Timepoint [3] 325335 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [4] 325336 0
Episodic memory will be assessed using the Rey Complex Figure Task
Timepoint [4] 325336 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [5] 325337 0
Working memory will be assessed using the forward and backward components of the digit span task from the Wechsler Adult Intelligence Scale battery.
Timepoint [5] 325337 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [6] 325339 0
Working memory will be assessed using an arithmetic task from the Wechsler Adult Intelligence Scale battery.
Timepoint [6] 325339 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [7] 325340 0
Executive functioning will be assessed using the Stroop test
Timepoint [7] 325340 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [8] 325342 0
Executive functioning will be assessed using a verbal fluency task. Namely, the Controlled Oral Word Association Test (COWAT)
Timepoint [8] 325342 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [9] 325344 0
Processing speed will be measured using a digit symbol coding task
Timepoint [9] 325344 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [10] 325346 0
Processing speed will be assessed using a trail making task
Timepoint [10] 325346 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment
Secondary outcome [11] 325358 0
The CogState is a composite measure of cognitive functioning. Subtests that measure reaction time and associative learning will be used.
Timepoint [11] 325358 0
Baseline and endpoint (i.e. pre and post sixteen sessions of tDCS) as well as at one month post final tDCS treatment

Eligibility
Key inclusion criteria
- 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
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- have a DSM-IV history of substance abuse or dependence in the last 6 months
- have a concomitant major and unstable medical, psychiatric or neurological illness
- are pregnant
- are currently taking medications shown to interfere with the effects of tDCS; namely benzodiazepines
- are professional drivers
- have any contraindications to brain stimulation ass assessed using the TMS/tDCS safety screen

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed; by the research assistant contacting the principal investigator who has a computer generated random sequence for treatment groups after the participant is deemed eligible and has consented for the study.
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. Microsoft Excel)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293979 0
University
Name [1] 293979 0
Monash University
Country [1] 293979 0
Australia
Primary sponsor type
Individual
Name
A/Prof Kate Hoy
Address
Monash Alfred Psychiatry Research Centre (MAPrc), Monash University
Level 4,
607 St Kilda Road,
Melbourne,
3004,
VIC
Country
Australia
Secondary sponsor category [1] 292795 0
None
Name [1] 292795 0
Address [1] 292795 0
Country [1] 292795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295397 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 295397 0
Ethics committee country [1] 295397 0
Australia
Date submitted for ethics approval [1] 295397 0
24/06/2016
Approval date [1] 295397 0
29/06/2016
Ethics approval number [1] 295397 0
257/16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67086 0
A/Prof Kate Hoy
Address 67086 0
Monash Alfred Psychiatry research centre (MAPrc)
Level 4
607 St Kilda Rd
Melbourne
Vic, 3004
Country 67086 0
Australia
Phone 67086 0
+613 9076 5034
Fax 67086 0
Email 67086 0
[email protected]
Contact person for public queries
Name 67087 0
Kate Hoy
Address 67087 0
Monash Alfred Psychiatry research centre (MAPrc)
Level 4
607 St Kilda Rd
Melbourne
Vic, 3004
Country 67087 0
Australia
Phone 67087 0
+613 9076 5034
Fax 67087 0
Email 67087 0
[email protected]
Contact person for scientific queries
Name 67088 0
Kate Hoy
Address 67088 0
Monash Alfred Psychiatry research centre (MAPrc)
Level 4
607 St Kilda Rd
Melbourne
Vic, 3004
Country 67088 0
Australia
Phone 67088 0
+613 9076 5034
Fax 67088 0
Email 67088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.