ANZCTR - Registration

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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

Scientific title

A longitudinal investigation of the neurophysiological changes related to cognitive performance and the effects of neuromodulation in Mild Cognitive Impairment

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mild Cognitive Impairment

Memory difficulties

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Treatment: Devices

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).

Control group

Placebo

Outcomes

Primary outcome [1]

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.

Timepoint [1]

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).

Primary outcome [2]

TMS-EEG evoked potential amplitudes will be assessed to measure changes in cortical activity within the prefrontal cortex in response to the tACS treatment.

Timepoint [2]

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).

Primary outcome [3]

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.

Timepoint [3]

One week pre-Acute Phase and 12-months post-Acute Phase (primary endpoint).

Secondary outcome [1]

Genotypes (DNA) implicated in Alzheimer's Disease will be examined as an exploratory outcome using a blood sample.

Timepoint [1]

Peripheral blood samples will be collected and stored at one week pre-Acute Phase.

Secondary outcome [2]

Epigenetic changes (methylation) and expression of genes (mRNA) will be assessed in a composite manner using a blood sample.

Timepoint [2]

One week pre-Acute Phase each year.

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.

Minimum age

50 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

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.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Device condition is coded; central randomisation by computer.

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.

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
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

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.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

22/11/2018

Date of last participant enrolment

Anticipated

22/02/2030

Actual

Date of last data collection

Anticipated

30/11/2033

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment hospital [2]

Epworth Rehabilitation Camberwell - Camberwell

Recruitment postcode(s) [1]

3004 - Prahran

Recruitment postcode(s) [2]

3004 - St Kilda Road Melbourne

Recruitment postcode(s) [3]

3124 - Camberwell

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Monash University
Wellington Rd, Clayton, VIC 3800

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Rd, Clayton, VIC 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

The Alfred Hospital
55 Commercial Rd, Melbourne, VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/05/2018

Approval date [1]

13/08/2018

Ethics approval number [1]

274/18

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Kate Hoy

Address

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

Country

Australia

Phone

+61 3 9076 5034

Fax

kate.hoy@monash.edu

Contact person for public queries

Name

Freya Stockman

Address

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

Country

Australia

Phone

+61 3 9076 9896

Fax

freya.stockman@monash.edu

Contact person for scientific queries

Name

Kate Hoy

Address

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

Country

Australia

Phone

+61 3 9076 5034

Fax

kate.hoy@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual participant data will not become available to other researchers.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Data has not yet been analysed

Documents added automatically

No additional documents have been identified.

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