ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000870156

Ethics application status

Approved

Date submitted

12/06/2019

Date registered

19/06/2019

Date last updated

29/08/2022

Date data sharing statement initially provided

19/06/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Mild non-invasive brain stimulation for apathy in Huntington's disease

Scientific title

Transcranial alternating current stimulation for apathy in Huntington's disease

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1235-1008

Trial acronym

Linked study record

Health condition

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

Huntington's disease

Apathy

Condition category

Condition code

Neurological

Other neurological disorders

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Randomized and counterbalanced sequence of three sessions of transcranial alternating current stimulation (tACS) conducted at least 72 hours apart, with details as follows:
1) 20 minutes and 2mA at the participants peak individualised alpha frequency;
2) 20 minutes and 2mA at 2Hz (delta frequency);
3) 20 minutes of sham (placebo) with 30 seconds 'fade in' followed by an immediate 30 seconds 'fade out'.
TACS is administered using a Startstim wireless hybrid electroencephalography(EEG)/transcranial current stimulation 8-channel system (Neuroelectrics, Spain).
EEG obtained via a 50-channel Neuroscan EEG system.
All data collection (baseline measures, resting and task-related EEG) and tACS administration is conducted by Marie-Claire Davis (Registered Psychologist with practice endorsement in Clinical Neuropsychology and PhD candidate).

Intervention code [1]

Treatment: Devices

Comparator / control treatment

3) 20 minutes of sham (placebo) with 30 seconds 'fade in' followed by an immediate 30 seconds 'fade out'.

Control group

Placebo

Outcomes

Primary outcome [1]

Changes in resting power on electroencephalogram (EEG).

Timepoint [1]

Resting eyes closed and eyes open EEG measured immediately before and immediately after each stimulation condition.

Primary outcome [2]

Changes in event-related EEG activity during completion of the Monetary Incentive Delay (MID) task.

Timepoint [2]

The MID task completed immediately before and immediately after each stimulation condition.

Secondary outcome [1]

Total score on the Apathy Evaluation Scale Clinician version (AES-C).

Timepoint [1]

Baseline/session 1.

Eligibility

Key inclusion criteria

- Individuals with genetically confirmed prodromal or early stage HD, as well as individuals without HD matched for age, gender and education will be sought as participants.
- Participants with prodromal HD will need to be within approximately 12 years of expected motor onset or have a “disease burden score” (DBS) of at least 280, indices calculated using the prospective participant’s current age and number of CAG repeats on the affected allele.
- Participants with early stage manifest HD will need to have a total functional capacity (TFC) score greater than, or equal to 10 . The TFC is used to assess how much assistance a person with HD requires to perform tasks in five functional domains that decline with disease progression (i.e., occupation, finances, domestic chores, activities of daily living, and care level).

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Use of anticonvulsant medications or regular treatment with benzodiazepines (versus limited as-needed use, with none consumed within the 48 hours prior to an experimental session).
- Commencement or significant dosage alteration of other psychotropic medications (i.e., anti-depressants, anti-psychotics) during the four weeks prior to an experimental session.
- Choreiform movements that preclude tACS or EEG data collection.
- A current episode of psychiatric illness, or a current substance use or alcohol use disorder, initially assessed via the recruitment screen, and then as assessed and defined by the Mini International Neuropsychiatric Interview (MINI) 7.0.2.
- Any history of significant head injury or traumatic brain injury, as defined by a loss of consciousness greater than 30 minutes or requiring a hospital admission.
- Unstable medical illness.
- Pregnancy or breastfeeding.
- An uncorrected hearing or visual impairment (including difficulty with colour perception).
- Significant difficulties with understanding or communicating in English.
- Metallic implants within the head, a pacemaker, cochlear implant, medication pump or other electronic device within the body.

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 not concealed.

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

Actual

20/02/2019

Date of last participant enrolment

Anticipated

31/10/2021

Actual

30/07/2021

Date of last data collection

Anticipated

31/12/2021

Actual

2/08/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Wellington Road, Clayton, Victoria, 3800

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Road, Clayton, Victoria, 3800

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Epworth Centre for Innovation in Mental Health, Epworth Healthcare

Address [1]

888 Toorak Road, Camberwell, Victoria, 3124

Country [1]

Australia

Other collaborator category [1]

Hospital

Name [1]

Calvary Health Care Bethlehem

Address [1]

152 Como Parade West Parkdale VIC 3195

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Human Research Ethics Committee

Ethics committee address [1]

55 Commercial Road, Melbourne, Victoria, 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/10/2018

Ethics approval number [1]

485/18

Summary

Brief summary

Many people with Huntington’s disease (HD) experience problems with motivation, often referred to as “apathy”. This is thought to be because of how HD affects the frontal lobes of the brain. There are currently no effective treatments for apathy in HD. 
Recent research has looked at whether non-invasive brain stimulation can improve motivation in people experiencing other neurological conditions (e.g., stroke) with some promising results. The type of brain changes caused by HD mean that a gentle, non-invasive type of brain stimulation called transcranial alternating current stimulation (tACS) may be most effective. But there are different ways that tACS can be used, and some ways may be more effective than others. 
The purpose of this project is to investigate the best way of using tACS so that it changes brain activity and improves performance on a motivation task in people with HD as well as people without HD. If we can find an effective way of using tACS, then this may help in the development of interventions for reduced motivation in HD. 
This research project requires participants to attend three separate testing sessions during which they receive 20 minutes of tACS, have their brain activity recorded via EEG, and complete a task exploring motivation. 
During each session participants receive tACS targeting a different frequency. By frequency, we mean electrical brain waves. In one session they receive tACS at a low frequency (i.e., in the “delta” frequency range). In another session they receive tACS set at a middle frequency (i.e., in the “alpha” frequency range). In a third session they will receive sham (i.e., placebo) tACS.

Trial website

http://hrgv.org.au/Research/Current%20Research/ApathyBrainStimulation.html

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Kate Hoy

Address

Monash University, Epworth Centre for Innovation in Mental Health, 888 Toorak Road, Camberwell, Victoria, 3124

Country

Australia

Phone

+61 3 9805 4186

Fax

kate.hoy@monash.edu

Contact person for public queries

Name

Marie-Claire Davis

Address

Monash University, Epworth Centre for Innovation in Mental Health, 888 Toorak Road, Camberwell, Victoria, 3124

Country

Australia

Phone

+61 4 35 940 161

Fax

marie-claire.davis@monash.edu

Contact person for scientific queries

Name

Kate Hoy

Address

Monash University, Epworth Centre for Innovation in Mental Health, 888 Toorak Road, Camberwell, Victoria, 3124

Country

Australia

Phone

+61 3 9805 4186

Fax

kate.hoy@monash.edu

Data sharing statement

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

Yes

What data in particular will be shared?

Individual participant de-identified data.

When will data be available (start and end dates)?

If and when required as part of publishing the results. Outside these circumstances, then January 2023.

Available to whom?

Researchers who agree to preserve the confidentiality of the data, provide information regarding the proposed use of the data, and pending approval from the original research team.

Available for what types of analyses?

As approved by the original research team.

How or where can data be obtained?

Access subject to approval by the original research team.

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

Source	Title	Year of Publication	DOI
Embase	Motivationally salient cue processing measured using the monetary incentive delay (MID) task with electroencephalography (EEG): A potential marker of apathy in Huntington's disease.	2022	https://dx.doi.org/10.1016/j.neuropsychologia.2022.108426
Embase	Medial prefrontal transcranial alternating current stimulation for apathy in Huntington's disease.	2023	https://dx.doi.org/10.1016/j.pnpbp.2023.110776
Embase	Neurophysiological correlates of non-motor symptoms in late premanifest and early-stage manifest huntington's disease.	2023	https://dx.doi.org/10.1016/j.clinph.2023.06.021

N.B. These documents automatically identified may not have been verified by the study sponsor.

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