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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
21/07/2020
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] 300985 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive compulsive disorder 317018 0
Condition category
Condition code
Mental Health 315185 315185 0 0
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] 317307 0
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] 323442 0
Change in clinical severity of OCD, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Timepoint [1] 323442 0
Assessed at baseline, 3-week, 6-week and 3-month follow-up appointments
Secondary outcome [1] 381961 0
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] 381961 0
Assessed at baseline, 3-week, 6-week and 3-month follow-up appointments
Secondary outcome [2] 381962 0
Change in event related potentials (error related negativity and N200) as measured by EEG
Timepoint [2] 381962 0
EEG recording at baseline and post-treatment (at 6 weeks)
Secondary outcome [3] 381963 0
Change in overall anxiety symptoms as measured by the Beck Anxiety Inventory.
Timepoint [3] 381963 0
Assessed at baseline, 3-week, 6-week and 3-month follow-up appointments
Secondary outcome [4] 384709 0
Change in overall depressive symptoms as measured by Quick Inventory of Depressive Symptoms – self report
Timepoint [4] 384709 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16415 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 29959 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 305431 0
University
Name [1] 305431 0
Monash University
Address [1] 305431 0
Wellington Rd, Clayton VIC 3800
Country [1] 305431 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 305823 0
None
Name [1] 305823 0
Address [1] 305823 0
Country [1] 305823 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305750 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 305750 0
246 Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 305750 0
Australia
Date submitted for ethics approval [1] 305750 0
22/04/2020
Approval date [1] 305750 0
28/05/2020
Ethics approval number [1] 305750 0
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 101462 0
Prof Paul Fitzgerald
Address 101462 0
Epworth Centre for Innovation in Mental Health
Epworth HealthCare
888, Toorak Road,
Camberwell
VIC 3124
Country 101462 0
Australia
Phone 101462 0
+61 398 054 287
Fax 101462 0
Email 101462 0
paul.fitzgerald@monash.edu
Contact person for public queries
Name 101463 0
Ms M. Prabhavi N. Perera
Address 101463 0
Epworth Centre for Innovation in Mental Health
Epworth HealthCare
888, Toorak Road,
Camberwell
VIC 3124
Country 101463 0
Australia
Phone 101463 0
+61 398 054 163
Fax 101463 0
Email 101463 0
magelage.perera@monash.edu
Contact person for scientific queries
Name 101464 0
Prof Paul Fitzgerald
Address 101464 0
Epworth Centre for Innovation in Mental Health
Epworth HealthCare
888, Toorak Road,
Camberwell
VIC 3124
Country 101464 0
Australia
Phone 101464 0
+61 398 054 287
Fax 101464 0
Email 101464 0
paul.fitzgerald@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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 other documents available
Summary results
No Results