ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000748910

Ethics application status

Approved

Date submitted

7/06/2020

Date registered

21/07/2020

Date last updated

2/12/2022

Date data sharing statement initially provided

21/07/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Therapeutic use of transcranial Alternating Current Stimulation for Obsessive Compulsive Disorder

Scientific title

Therapeutic use of transcranial Alternating Current Stimulation for Obsessive Compulsive Disorder

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obsessive compulsive disorder

Condition category

Condition code

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Transcranial Alternating Current (tACS) is a form of non-invasive brain stimulation that delivers a weak electrical current that alternates at a specified frequency back and forth between electrodes. The tACS device in this trial (BrightStim) consists of a purpose-built handheld battery driven unit that delivers a current controlled voltage across an active and reference electrode. The active and reference electrodes are placed within commercially supplied saline soaked sponges. We have developed this device within our research team to produce the same effects as existing commercial devices but to be programmable in a manner that the research team can preset the conditions of use with no capacity for the patients to alter this or use the device in a manner outside of our research protocol. The device has been certified for use by the Alfred Hospital Bioengineering department.
To date, there have been hundreds of studies of tACS, including in people with depression, conducted internationally. There have been no issues or problems reported in these studies over and above the known side effects.

The BrightStim stimulator is currently being used in a clinical trial in the prevention of dementia in people with mild cognitive impairment (Alfred Health Ethics Approval 274/18, CTN number CT-2018- CTN-03008-1), and has been approved for a clinical trial in depression for young people by Monash Health Human Research Ethics Committee (RES-18-0000-521A). It has also been used in other experimental studies with healthy controls by our research group, and has also been demonstrated to produce effects equivalent to those produced with a widely commercially available device in a structured assessment. No safety or other issues/problems arose in any of these studies.

Mode of action: polarisation of neurons via mild electrical current
Dosage Regime: tACS will be applied targeting the medial prefrontal cortex with a placement of electrodes at the AFz and Iz positions. Individualised alpha frequency will be determined for participants that attend a pre-treatment EEG session and stimulation will occur at this frequency. For remote participants, stimulation frequency will be set at 10Hz. Stimulation intensity is set at 1.5mA. Treatment will occur over a six-week period in both the initial and cross over study phases. During the first three weeks, participants will receive treatment twice daily (intensive treatment phase), 5 days per week. In the subsequent three weeks, they will receive treatment once daily, three days per week (consolidation phase). After this, they will be followed up for three months to evaluate whether they have achieved treatment persistent benefits. After this time, in the open label crossover phase, participants who initially received sham will receive active tACS for 6 weeks with intensive (3 weeks) and consolidation phases (3 weeks) as before.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Sham/placebo tACS is achieved by switching off stimulation after approximately 30 seconds, which occurs within the software of the BrightStim system allowing for administrator and participant blinding. There is no evidence that 30 seconds of tACS induces any changes in the brain. The provision of stimulation for 30 seconds allows participants to experience the initial physical sensations of tACS, which typically
fade after 30 seconds, thus providing a robust sham. This is a standard method of blinding for tACS.

Control group

Placebo

Outcomes

Primary outcome [1]

Change in clinical severity of OCD, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

Timepoint [1]

Assessed at baseline, 3-week, 6-week and 3-month follow-up appointments

Secondary outcome [1]

Changes in overall cognitive ability, which will be assessed using a battery of cognitive tests (composite outcome). Following are the cognitive tests that will be used:
Response inhibition – Go/NoGo task
Working memory – n-back task
Selective attention – Auditory selective attention task
Processing speed – Symbol search

Timepoint [1]

Assessed at baseline, 3-week, 6-week and 3-month follow-up appointments

Secondary outcome [2]

Change in event related potentials (error related negativity and N200) as measured by EEG

Timepoint [2]

EEG recording at baseline and post-treatment (at 6 weeks)

Secondary outcome [3]

Change in overall anxiety symptoms as measured by the Beck Anxiety Inventory.

Timepoint [3]

Assessed at baseline, 3-week, 6-week and 3-month follow-up appointments

Secondary outcome [4]

Change in overall depressive symptoms as measured by Quick Inventory of Depressive Symptoms – self report

Timepoint [4]

Assessed at baseline, 3-week, 6-week and 3-month follow-up appointments

Eligibility

Key inclusion criteria

• 18-65 years of age.
• Diagnosis of OCD, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
• Have not initiated new OCD treatment (pharmacological or behavioural) or increased dosage of current psychopharmacological treatment in the past 6 weeks.
• Demonstrated capacity to give informed consent.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Are currently pregnant or breastfeeding.
• Presence of metal (screws, clips) anywhere in the head, except the mouth.
• Have an unstable medical condition or a neurological disorder.
• Have been diagnosed with another personality or psychiatric disorder except depression or another anxiety disorder.
• Unable to provide informed consent

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)

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 analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The primary analysis will be conducted on YBOCS scores from baseline to week-6. ANOVA tests will be used to examine for differences between demographic and clinical characteristics between groups for continuous and categorical variables following testing for normality of the data. Mixed model analysis of the primary and secondary outcome variables will be computed to look for differences in group scores across study time points (baseline, week 3, week 6) with treatment types as the between-group and time as the within-subject factor. Concurrent medication use will be included in these analyses as covariate.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties
Other reasons/comments

Other reasons

Due to COVID-19 related restrictions. the target sample size of 40 could not be reached.

Date of first participant enrolment

Anticipated

7/08/2020

Actual

28/08/2020

Date of last participant enrolment

Anticipated

31/03/2022

Actual

7/04/2022

Date of last data collection

Anticipated

1/07/2022

Actual

25/08/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Epworth Rehabilitation Camberwell - Camberwell

Recruitment postcode(s) [1]

3124 - Camberwell

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

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]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

246 Clayton Road
Clayton
VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/04/2020

Approval date [1]

28/05/2020

Ethics approval number [1]

RES-20-0000-265A

Summary

Brief summary

Obsessive-compulsive disorder (OCD) is a common, disabling mental illness that is difficult to treat. Electroencephalographic (EEG) studies have shown numerous differences in the brain oscillatory activity in OCD patients when compared to healthy individuals. Transcranial alternating current stimulation (tACS) is a novel, safe method of delivering a weak electrical current through the brain in order to modulate the altered brain activity. The main advantage of tACS is its ability to stimulate the brain at specific frequencies that are found to be altered in OCD groups. This study aims to conduct a randomised, controlled, blinded experimental study with an open label crossover phase to explore the use of alpha tACS when compared to a placebo/sham stimulation in individuals with OCD. Participants will use a custom designed, portable tACS device to administer stimulation at their homes. The main aim is to investigate whether alpha tACS is able to cause a significant improvement in clinical severity than placebo stimulation in OCD patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Paul Fitzgerald

Address

Epworth Centre for Innovation in Mental Health
Epworth HealthCare
888, Toorak Road,
Camberwell
VIC 3124

Country

Australia

Phone

+61 398 054 287

Fax

paul.fitzgerald@monash.edu

Contact person for public queries

Name

M. Prabhavi N. Perera

Address

Epworth Centre for Innovation in Mental Health
Epworth HealthCare
888, Toorak Road,
Camberwell
VIC 3124

Country

Australia

Phone

+61 398 054 163

Fax

magelage.perera@monash.edu

Contact person for scientific queries

Name

Paul Fitzgerald

Address

Epworth Centre for Innovation in Mental Health
Epworth HealthCare
888, Toorak Road,
Camberwell
VIC 3124

Country

Australia

Phone

+61 398 054 287

Fax

paul.fitzgerald@monash.edu

Data sharing statement

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

No/undecided IPD sharing reason/comment

Procedures around making data available are still being developed. It is anticipated the results of this research project will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that participants cannot be identified, except with their permission.

It is possible that as a requirement of publishing the study in scientific journals, de-identified data may need to be placed in an open access data repository. No identifiable information that links this data back to the participants will be provided. As discussed above, procedures around availability of data have not yet been finalised.

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	Home-Based Individualized Alpha Transcranial Alternating Current Stimulation Improves Symptoms of Obsessive-Compulsive Disorder: Preliminary Evidence from a Randomized, Sham-Controlled Clinical Trial.	2023	https://dx.doi.org/10.1155/2023/9958884

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

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Documents added manually

Documents added automatically