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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] 304024 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 321655 0
Condition category
Condition code
Mental Health 319404 319404 0 0
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] 320345 0
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] 327265 0
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] 327265 0
Baseline, immediately following treatment session 10 (primary timepoint) and follow-up (4 weeks from treatment session 10).
Secondary outcome [1] 394394 0
Self-reported depressive symptoms, measured using the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR). Score ranges from 0-27.
Timepoint [1] 394394 0
Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).
Secondary outcome [2] 394395 0
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] 394395 0
Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).
Secondary outcome [3] 394396 0
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] 394396 0
Baseline, at treatment session 5, treatment session 10 and at follow-up (4 weeks from treatment session 10).
Secondary outcome [4] 405857 0
Quantitative Electroencephalogram (QEEG) measures of amplitude, power, frequency and distribution in the alpha band particularly.
Timepoint [4] 405857 0
Baseline and after treatment session 10.
Secondary outcome [5] 406472 0
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] 406472 0
Baseline and 1-4 hours after treatment session 10.
Secondary outcome [6] 406473 0
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] 406473 0
Baseline, immediately following treatment session 10) and follow-up (4 weeks from treatment session 10.
Secondary outcome [7] 406474 0
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] 406474 0
Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).
Secondary outcome [8] 406475 0
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] 406475 0
Baseline, immediately following treatment session 10 and follow-up (4 weeks from treatment session 10).
Secondary outcome [9] 406476 0
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] 406476 0
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?
No
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
50
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21637 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 21638 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 36566 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 308407 0
Charities/Societies/Foundations
Name [1] 308407 0
Austin Medical Research Foundation (AMRF)
Country [1] 308407 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 - 163 Studley Road
Heidelberg Vic 3084
Australia
Country
Australia
Secondary sponsor category [1] 309241 0
None
Name [1] 309241 0
Address [1] 309241 0
Country [1] 309241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308369 0
Austin Health HREC
Ethics committee address [1] 308369 0
L8 Harold Stokes Building,
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
Ethics committee country [1] 308369 0
Australia
Date submitted for ethics approval [1] 308369 0
24/11/2020
Approval date [1] 308369 0
09/12/2021
Ethics approval number [1] 308369 0
HREC/69149/Austin-2021
Ethics committee name [2] 310277 0
Departments of Defence and Veterans' Affairs HREC
Ethics committee address [2] 310277 0
Campbell Park Offices
PO Box 7911
CANBERRA BC ACT 2610
Ethics committee country [2] 310277 0
Australia
Date submitted for ethics approval [2] 310277 0
21/03/2021
Approval date [2] 310277 0
29/09/2021
Ethics approval number [2] 310277 0
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 110470 0
Dr Tim Rolfe
Address 110470 0
Psychological Trauma Recovery Service (PTRS)
Coral Balmoral Building
300 Waterdale Road
Heidelberg West
Victoria 3081
Country 110470 0
Australia
Phone 110470 0
+61418510343
Fax 110470 0
Email 110470 0
Tim.Rolfe@austin.org.au
Contact person for public queries
Name 110471 0
Tim Rolfe
Address 110471 0
Psychological Trauma Recovery Service (PTRS)
Coral Balmoral Building
300 Waterdale Road
Heidelberg West
Victoria 3081
Country 110471 0
Australia
Phone 110471 0
+61418510343
Fax 110471 0
Email 110471 0
Tim.Rolfe@austin.org.au
Contact person for scientific queries
Name 110472 0
Tim Rolfe
Address 110472 0
Psychological Trauma Recovery Service (PTRS)
Coral Balmoral Building
300 Waterdale Road
Heidelberg West
Victoria 3081
Country 110472 0
Australia
Phone 110472 0
+61418510343
Fax 110472 0
Email 110472 0
Tim.Rolfe@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidential medical records


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14916Study protocol  Tim.Rolfe@austin.org.au
14917Informed consent form  Tim.Rolfe@austin.org.au
14918Ethical approval  Tim.Rolfe@austin.org.au
14919Statistical analysis plan  Tim.Rolfe@austin.org.au



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.