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Trial registered on ANZCTR

Registration number

ACTRN12616001045404

Ethics application status

Approved

Date submitted

10/11/2015

Date registered

5/08/2016

Date last updated

13/06/2019

Date data sharing statement initially provided

17/04/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A clinical trial to evaluate the safety and efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to improve cognitive flexibility and emotional self-regulation in young people with autism spectrum disorder

Scientific title

A clinical trial to evaluate the safety and efficacy of high-definition transcranial direct current stimulation (HD-tDCS) using a probabilistic reversal task and a cognitive reappraisal task combined with electroencephalography to improve cognitive flexibility and emotional self-regulation in young people with autism spectrum disorders.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1175-8550

Trial acronym

N/A

Linked study record

Health condition

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

Autism Spectrum Disorders

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study involves the use of high-definition transcranial direct current stimulation (HD-tDCS) over the ventrolateral prefrontal cortex to improve cognitive flexibility and emotional self-regulation in young people with autism spectrum disorder (ASD).
The intervention frequency will be one session of 20 minutes of HD-tDCS for 4 consecutive days. The intensity of the total injected current is 1.693 milliamps (mA). It includes a ramp-up and rump-down period of 30 seconds. This is a double blind study where twenty participants will receive both active and sham (placebo) stimulation. These two stimulations conditions will be randomized across participants, and there will be a 4-week washout period in between. HD-tDCS involves a weak electrical current applied to the brain area of interest via small electrodes placed on the scalp.
A trained expert in non-invasive brain stimulation techniques with a first aid accreditation will administer the HD-tDCS.
A safety HD-tDCS protocol will be given to participants before and after each session.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The control treatment consists in the administration of sham (placebo) HD-tDCS stimulation over the ventrolateral prefrontal cortex, the same brain region used for the active treatment.
Sham treatment will be administered for 20 minutes, same as the active treatment.
TDCS sham procedures consist in switching off the stimulator after 30 s of the stimulation, this has been shown to be effective as subjects failed to discern between active and sham stimulation.

Control group

Placebo

Outcomes

Primary outcome [1]

Changes in electroencephalography components when conducting a probabilistic reversal task. Specifically, changes in feedback related negativity (FRN) component of the probabilistic reversal task will be investigated as our primary outcome measure. The version of the probabilistic reversal learning task used in this clinical trial can be found in Chase el al., 2011, Journal of Cognitive Neuroscience.

Timepoint [1]

Active HD-tDCS: Baseline, 1 day after last treatment session (day 5),
Sham (placebo) HD-tDCS: BASELINE, 1 day after last treatment session (day 5),

Primary outcome [2]

Changes in electroencephalography components when conducting a cognitive reappraisal task which measures emotional self-regulation tasks. Specifically, changes in the amplitude of the late positive potential (LPP) of the cognitive reappraisal task will be investigated as our primary outcome measures. The cognitive reappraisal task is a well validated task that has been used in many research studies to measure emotional regulation (Feeser et al., 2014). For this clinical trial we will use a similar version seen in Parvaz et al., 2012, Cognitive Affective Behavioural Neuroscience,

Timepoint [2]

Active HD-tDCS: Baseline, 1 day after last treatment session (day 5).
Sham (placebo) HD-tDCS: BASELINE, 1 day after last treatment session (day 5),

Secondary outcome [1]

Global executive functioning assessed using the Behavior Rating Inventory of Executive Function - Adult Version "Trademark" (BRIEF-A "Trademark"),

Timepoint [1]

Active HD-tDCS: Baseline, 1 day after last treatment session (day 5), 2 weeks after last treatment session (day 14).

Sham (placebo) HD-tDCS: BASELINE, 1 day after last treatment session (day 5), 2 weeks after last treatment session (day 14).

Secondary outcome [2]

Repetitive behaviours assessed using the REPETITIVE BEHAVIOR SCALE – Revised (RBS-R).

Timepoint [2]

Active HD-tDCS: Baseline, 1 day after last treatment session (day 5), 2 weeks after last treatment session (day 14).

Sham HD-tDCS: Baseline, 1 day after last treatment session (day 5), 2 weeks after last treatment session (day 14).

Secondary outcome [3]

Autism symptoms assessed using the Social Responsiveness Scale "Trademark" (SRS "Trademark") .

Timepoint [3]

Baseline, 1 week post first treatment session (day 8) and one month post first treatment session (day 30).

Eligibility

Key inclusion criteria

Right and left handed individuals with a diagnosis of autism spectrum disorder with mild intellectual ability or higher (IQ>55).
Stable medication regime for at least 4 weeks, and stable throughout duration of enrolment in study.

Minimum age

16 Years

Maximum age

55 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

-Participants whose primary language is other than English.
- Pregnant women.
- Participants <16 years old.
- Participants with metal implants in their heads.
- Major medical or neurological condition

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)

Treatment allocation concealment will be achieved by using a password protected computer program, implemented by a member of the Cognitive Neuroscience Unit at Deakin University who will inform the principal investigator of the outcome via email.
The person who will determine the eligibility of the participants will be unaware of which stimulation will be given in each of the two treatment weeks.

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 assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The sample size of 40 participants will be reduced to 20. After doing the appropriate power analysis, results revealed that a sample of 20 participants provides 85% power to detect a true effect. The consultant biostatistician performing the analyses will be blind to participants’ order of allocation to treatment groups. Descriptive analyses will be used to characterise demographic and outcome variables (t-test, squared chi or ANOVAs). Mainly, a repeated measures ANOVA will be used to test the study hypothesis.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

20/04/2018

Actual

11/05/2018

Date of last participant enrolment

Anticipated

15/10/2019

Actual

5/05/2019

Date of last data collection

Anticipated

22/12/2019

Actual

7/06/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

Melbourne Burwood Campus, 221 Burwood Highway, VIC 3125

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

Melbourne Burwood Campus, 221 Burwood Highway, VIC 3125

Country

Australia

Secondary sponsor category [1]

None

Name [1]

n/a

Address [1]

n/a

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Guidelines

Ethics committee address [1]

Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/01/2018

Approval date [1]

29/01/2018

Ethics approval number [1]

Summary

Brief summary

ASD is characterized by: i) social deficits and ii) repetitive and restrictive patterns of behaviours and interests (RRPBIs). RRPBIs has been less researched in the scientific literature than the more salient social deficits. However, RRPBIs lead to severe impairments in cognitive flexibility skills and daily functioning. Some of the characteristics of RRPBIs include inflexible routines (e.g., not eating food that is coloured green or going outside without a favourite pair of shoes), rigid adherence to rules, resistance to change, obsessions, and difficulties adapting to new social contexts. Additionally, people with ASD showing highly rigid behaviour and thinking may persevere obsessively in a conversation topic or get very upset when their routine changes (e.g., always going to the shops the same way). These problems are intimately related to failures of emotional self-regulation, which is used to control one's behaviour, particularly when experiencing intrusive thoughts and negative emotions, and is thus essential for adaptive social interactions and daily functioning. Cognitive inflexibility and impairments in emotional self-regulation may also lead to increased levels of parental stress and negative parenting styles that decreases quality of life for both children and parents. 
Inflexible and perseverative behaviours can be measured using reversal learning paradigms whereas emotional self-regulation is usually measured using cognitive reappraisal tasks. These two processes are widely distributed across the brain. Recent cognitive neuroscience research has revealed that a single brain region within the frontal lobe, the ventrolateral prefrontal cortex (vlPFC) is primarily responsible for monitoring cognitive flexibility and controlling negative emotions, thoughts, and behaviours. Moreover, recent evidence from brain scanning techniques demonstrate abnormal activity within the vlPFC in ASD. Thus, the vlPFC is a clear target for neurobiological treatment of cognitive inflexibility and impairments in emotional self-regulation in ASD. 20 participants between 16–30 years with ASD will be recruited. Participants will undergo 1 day of pre-testing; 4 consecutive days of 20 minutes anodal or sham HD-tDCS stimulation (depending on order of administration); half-a-day of post-testing the day after the last stimulation session; a 2-week follow-up assessment. After a 4-week washout period, participants repeat the prior process in the opposite treatment condition they commenced with (anodal or sham HD-tDCS). The is a randomised, double-blind, crossover trial that aims to (a) investigate the safety of using HD-tDCS within ASD and (b) to investigate the efficacy of using HD-tDCS to reduce impairments in cognitive flexibility and emotional self-regulation skills among individuals with ASD. We will examine a range of clinical, neuropsychological and neurophysiological features. Participants’ experience of HD-tDCS, including any side effects will be collected.

Trial website

n/a

Trial related presentations / publications

n/a

Public notes

Contacts

Principal investigator

Name

Dr NATALIA ALBEIN-URIOS

Address

Deakin University

Melbourne Burwood Campus, 221 Burwood Highway, VIC 3125

Country

Australia

Phone

+61 92517813

Fax

natalia.albeinurios@deakin.edu.au

Contact person for public queries

Name

NATALIA ALBEIN-URIOS

Address

Deakin University

Melbourne Burwood Campus, 221 Burwood Highway, VIC 3125

Country

Australia

Phone

+61 92517813

Fax

natalia.albeinurios@deakin.edu.au

Contact person for scientific queries

Name

NATALIA ALBEIN-URIOS

Address

Deakin University

Melbourne Burwood Campus, 221 Burwood Highway, VIC 3125

Country

Australia

Phone

+61 92517813

Fax

natalia.albeinurios@deakin.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

The clinical trial data from the participants will be confidential.

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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