ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000339752

Ethics application status

Approved

Date submitted

3/02/2022

Date registered

24/02/2022

Date last updated

12/08/2022

Date data sharing statement initially provided

24/02/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Transcranial Direct Current Stimulation for Post-Traumatic Stress Disorder

Scientific title

A randomised, sham controlled clinical trial using Transcranial Direct Current Stimulation for Post-Traumatic Stress Disorder

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Post Traumatic Stress Disorder

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Administration of transcranial Direct Current Stimulation using a Soterix Mini-CT Low-Intensity Transcranial Electrical Stimulator with bifrontal electrode montage. Anode located over the left dorsolateral prefrontal cortex and cathode over the right dorsolateral prefrontal cortex (corresponding to F3 and F4 respectively). A direct current of 2.0 milliamps delivered for 20 minutes. Electrodes located and applied for each treatment by a medically trained administrator. Treatment continuously supervised. Treatment administered once/day for 10 consecutive days (Monday to Friday).
At the completion of treatment the device records a log that shows the number of PAUSE EVENTS (number of times device PAUSED), CRITICAL EVENTS (number of times device detected POOR contact quality or outside the desired range), CRITICAL TIME (duration device was operated under POOR quality conditions), and TOTAL TIME (total duration of the session run).

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control consists of identical electrode placement. Sham is selected on Soterix device. Current is "ramped" (increased slowly to 2mAmps) over 30 seconds and then reduced to zero. This provides an identical sensation to the initiation of the experimental condition.

Control group

Placebo

Outcomes

Primary outcome [1]

Overall symptom severity, measured by the Posttraumatic Stress Disorder Checklist (PCL-5). Consists of 20 items each rated 0-4. Total score between 0-80.

Timepoint [1]

Baseline, immediately following treatment session 10 (primary timepoint) and follow-up (4 weeks from treatment session 10).

Secondary outcome [1]

Self-reported depressive symptoms, measured using the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR). Score ranges from 0-27.

Timepoint [1]

Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).

Secondary outcome [2]

Clinician rated depressive symptoms, using the Montgomery Asberg Depression Rating Scale (MADRS). This is a 10-item scale, each rated 0-6. Total score ranges from 0-60.

Timepoint [2]

Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).

Secondary outcome [3]

Self-reported side-effects using the tDCS Adverse Event Questionnaire. This has been used in previous studies examining effectiveness and safety of tDCS. It consists of 10 items each rated on a 1-4 scale for severity and 1- 4 for related to the tDCS. Examples of commonly reported side-effects include headache, tingling, itchiness and redness at the electrode sites.

Timepoint [3]

Baseline, at treatment session 5, treatment session 10 and at follow-up (4 weeks from treatment session 10).

Secondary outcome [4]

Quantitative Electroencephalogram (QEEG) measures of amplitude, power, frequency and distribution in the alpha band particularly.

Timepoint [4]

Baseline and after treatment session 10.

Secondary outcome [5]

Event-related potentials (ERP's) measured during a visual continuous performance task (to capture P3a in particular). This has been reported to be abnormal in patients with PTSD.

Timepoint [5]

Baseline and 1-4 hours after treatment session 10.

Secondary outcome [6]

The "Re-experiencing" cluster of the PCL-5.. This consists of items 1-5, each rated on a 0-4 scale. Total score 0-20.

Timepoint [6]

Baseline, immediately following treatment session 10) and follow-up (4 weeks from treatment session 10.

Secondary outcome [7]

The "Avoidance" cluster of the PCL-5. This consists of items 6-7, each rated on a 0-4 scale. Total score 0-8.

Timepoint [7]

Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).

Secondary outcome [8]

The "Negative cognition & mood" cluster of the PCL-5. This consists of items 8-14, each rated on a 0-4 scale. Total score 0-28.

Timepoint [8]

Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).

Secondary outcome [9]

The "Hypervigilance" cluster of the PCL-5. This consists of items 15-20, each rated on a 0-4 scale. Total score 0-24.

Timepoint [9]

Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).

Eligibility

Key inclusion criteria

• Admitted to hospital
• Clinical diagnosis of PTSD by Consultant Psychiatrist
• Capacity for consent
• PCL-5 score above 50

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Presence of metallic objects in or around the head
• Medical disorder such as epilepsy or head injury
• High suicide risk (measured by standard Risk Assessment, requiring hourly or greater observation)

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)

Random allocation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Any differences in the active and sham groups will be compared using the independent t-test for continuous variables and chi-squared or Fisher’s exact test for categorical variables. Any pre-treatment group differences between the (dependent) outcome variables will be compared using a multiple analysis of variance (MANOVA). The effect of medication changes during the study period will also be assessed using this method. Treatment outcomes will be analysed using a 2 x 3 mixed model analysis, using an intention to treat analysis (2 treatment conditions and 3 assessment times).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

28/02/2022

Actual

26/05/2022

Date of last participant enrolment

Anticipated

24/02/2023

Actual

Date of last data collection

Anticipated

24/03/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3081 - Heidelberg West

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Austin Medical Research Foundation (AMRF)

Address [1]

Austin Hospital
145 - 163 Studley Road
Heidelberg Vic 3084
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 - 163 Studley Road
Heidelberg Vic 3084
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health HREC

Ethics committee address [1]

L8 Harold Stokes Building,
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/11/2020

Approval date [1]

09/12/2021

Ethics approval number [1]

HREC/69149/Austin-2021

Ethics committee name [2]

Departments of Defence and Veterans' Affairs HREC

Ethics committee address [2]

Campbell Park Offices
PO Box 7911
CANBERRA BC ACT 2610

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

21/03/2021

Approval date [2]

29/09/2021

Ethics approval number [2]

345-2

Summary

Brief summary

Post-Traumatic Stress Disorder (PTSD) is a common and disabling condition. It has significant costs in terms of lost productivity, treatment costs, morbidity and excess mortality (including suicide and premature death from co-morbid medical conditions). Current treatments are only effective in one third of patients. There is a pressing need for new treatments.
Transcranial Direct Current Stimulation is a novel, non-invasive method of stimulating the brain in order to produce clinical effects. It has been used widely to treat symptoms of depression. Only one small study has examined its effect on symptoms of PTSD, the results were promising. 
tDCS is an easily administered treatment with low cost and few side-effects. It can be provided using small portable devices and can be administered remotely. This can address one of the key obstacles to current neurostimulation treatments, that of access. 
The proposed study aims to investigate the impact of tDCS compared to sham tDCS in participants with severe PTSD. Participants will be recruited from the Psychological Trauma Recovery Service inpatient unit. After giving informed consent, participants will be randomised to receive either active or sham tDCS for 20 minutes/day for 10 days over 2 weeks. Measured outcomes will include symptoms of PTSD, depression, side-effects of tDCS and results of electroencephalogram (EEG) studies.
Should this study replicate the successful findings of a similar recently published trial then this treatment could be a very significant addition to the currently available treatments for PTSD.

Trial website

Trial related presentations / publications

Public notes

This study is funded by the Austin Medical Research Foundation (AMRF). It supports more than 800 researchers in hospital departments, three University of Melbourne departments and four independent research institutes at the Austin precinct.

AMRF funding is designed to ensure the best outcome for patients. Support enables established researchers to explore innovative ideas and encourages tomorrow’s future research stars. This type of support has already resulted in many advances in patient care and treatments, including for patients with cancer and those in intensive care.

https://www.austinmrf.org.au/

Contacts

Principal investigator

Name

Dr Tim Rolfe

Address

Psychological Trauma Recovery Service (PTRS)
Coral Balmoral Building
300 Waterdale Road
Heidelberg West
Victoria 3081

Country

Australia

Phone

+61418510343

Fax

[email protected]

Contact person for public queries

Name

Tim Rolfe

Address

Psychological Trauma Recovery Service (PTRS)
Coral Balmoral Building
300 Waterdale Road
Heidelberg West
Victoria 3081

Country

Australia

Phone

+61418510343

Fax

[email protected]

Contact person for scientific queries

Name

Tim Rolfe

Address

Psychological Trauma Recovery Service (PTRS)
Coral Balmoral Building
300 Waterdale Road
Heidelberg West
Victoria 3081

Country

Australia

Phone

+61418510343

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

Confidential medical records

What supporting documents are/will be available?

Doc. No.	Type	Email
14916	Study protocol	[email protected]
14917	Informed consent form	[email protected]
14918	Ethical approval	[email protected]
14919	Statistical analysis plan	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically