Trial Review

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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] 298464 0
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 313221 0
Apathy 313245 0
Condition category
Condition code
Neurological 311669 311669 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 311758 311758 0 0
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] 314704 0
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] 320371 0
Changes in resting power on electroencephalogram (EEG).
Timepoint [1] 320371 0
Resting eyes closed and eyes open EEG measured immediately before and immediately after each stimulation condition.
Primary outcome [2] 320439 0
Changes in event-related EEG activity during completion of the Monetary Incentive Delay (MID) task.
Timepoint [2] 320439 0
The MID task completed immediately before and immediately after each stimulation condition.
Secondary outcome [1] 371428 0
Total score on the Apathy Evaluation Scale Clinician version (AES-C).
Timepoint [1] 371428 0
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
60
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303007 0
University
Name [1] 303007 0
Monash University
Country [1] 303007 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road, Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 302995 0
Hospital
Name [1] 302995 0
Epworth Centre for Innovation in Mental Health, Epworth Healthcare
Address [1] 302995 0
888 Toorak Road, Camberwell, Victoria, 3124
Country [1] 302995 0
Australia
Other collaborator category [1] 282006 0
Hospital
Name [1] 282006 0
Calvary Health Care Bethlehem
Address [1] 282006 0
152 Como Parade West Parkdale VIC 3195
Country [1] 282006 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303558 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 303558 0
Ethics committee country [1] 303558 0
Australia
Date submitted for ethics approval [1] 303558 0
Approval date [1] 303558 0
03/10/2018
Ethics approval number [1] 303558 0
485/18

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

Contacts
Principal investigator
Name 94078 0
Prof Kate Hoy
Address 94078 0
Monash University, Epworth Centre for Innovation in Mental Health, 888 Toorak Road, Camberwell, Victoria, 3124
Country 94078 0
Australia
Phone 94078 0
+61 3 9805 4186
Fax 94078 0
Email 94078 0
[email protected]
Contact person for public queries
Name 94079 0
Marie-Claire Davis
Address 94079 0
Monash University, Epworth Centre for Innovation in Mental Health, 888 Toorak Road, Camberwell, Victoria, 3124
Country 94079 0
Australia
Phone 94079 0
+61 4 35 940 161
Fax 94079 0
Email 94079 0
[email protected]
Contact person for scientific queries
Name 94080 0
Kate Hoy
Address 94080 0
Monash University, Epworth Centre for Innovation in Mental Health, 888 Toorak Road, Camberwell, Victoria, 3124
Country 94080 0
Australia
Phone 94080 0
+61 3 9805 4186
Fax 94080 0
Email 94080 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseMotivationally salient cue processing measured using the monetary incentive delay (MID) task with electroencephalography (EEG): A potential marker of apathy in Huntington's disease.2022https://dx.doi.org/10.1016/j.neuropsychologia.2022.108426
EmbaseMedial prefrontal transcranial alternating current stimulation for apathy in Huntington's disease.2023https://dx.doi.org/10.1016/j.pnpbp.2023.110776
EmbaseNeurophysiological correlates of non-motor symptoms in late premanifest and early-stage manifest huntington's disease.2023https://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.