Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001023448
Ethics application status
Approved
Date submitted
29/07/2016
Date registered
2/08/2016
Date last updated
22/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of Theta Burst Stimulation (TBS) as a treatment for Posttraumatic Stress Disorder (PTSD) in an Australian Veteran Population – a pilot study
Scientific title
Evaluating the effectiveness of Theta Burst Stimulation (TBS) as a treatment for Posttraumatic Stress Disorder (PTSD) in an Australian Veteran Population – a pilot study
Secondary ID [1] 288969 0
None
Universal Trial Number (UTN)
Trial acronym
TBS for PTSD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder (PTSD) 298350 0
Condition category
Condition code
Mental Health 298462 298462 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a case series. Participants will receive active treatment with Theta Burst Stimulation (TBS) on a daily basis, Monday to Friday for four weeks. It will employ a repeated measures design, with participants assessed at (a) pre-treatment, (b) post-treatment, and (c) 3 months follow-up.

TBS treatment involves the application of magnetic stimulation to the prefrontal cortex (DLPFC), During TBS treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation. All stimulation will be conducted at the Monash Alfred Psychiatry Research Centre by a fully qualified and TMS certified research nurse. Participants will be monitored at all times, and each treatment time, date and dosage will be logged on a participant's treatment sheet.

TBS will be provided as 3-pulse 50 Hz bursts applied bilaterally, right then left, at 5 Hz (ie 50 Hz burst of 3 pulses delivered every 200 msec). It will involve a 2 second train of TBS followed by an 8 second rest and will run for a total of 190 seconds. Thus each treatment takes a little over 3 minutes. The treatment intensity for TBS will be 120% of resting motor threshold which is measured by administering single pulse TMS to the muscle controlling area of the brain.
Intervention code [1] 294454 0
Treatment: Devices
Comparator / control treatment
The study is an uncontrolled, pilot case series assessing the impact of TBS treatment on cognitive and mental health outcomes. All participants receive active TBS treatment within a repeated measures design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297954 0
Clinician Administered PTSD Scale (CAPS)
Timepoint [1] 297954 0
Baseline, at the conclusion of treatment and 3 month follow up
Secondary outcome [1] 322750 0
Working memory and processing speed subtests on the Wechsler Adult Intelligence Scale 4th edition (Digit span, Letter Number Sequencing, Coding and Symbol Search) and Cogstate Brief Battery
Timepoint [1] 322750 0
Baseline, at the conclusion of treatment and 3 month follow up
Secondary outcome [2] 322751 0
Hamilton Depression Rating Scale (HAMD)
Timepoint [2] 322751 0
Baseline, at the conclusion of treatment and at 3 month follow up
Secondary outcome [3] 322752 0
Emotional Regulation Questionnaire (ERQ9)
Timepoint [3] 322752 0
Baseline, at the conclusion of treatment and 3 month follow up
Secondary outcome [4] 322753 0
The Dimensions of Anger Scale - 5 (DAR-5)
Timepoint [4] 322753 0
Baseline, at the conclusion of treatment and 3 month follow up
Secondary outcome [5] 322754 0
Trail Making Test A & B (TMT) which measures information processing and complex attention
Timepoint [5] 322754 0
Baseline, at the conclusion of treatment and 3 months post treatment follow up

Eligibility
Key inclusion criteria
Potential participants will be included if they:
- Are a veteran (ex-serving member of the Australian Defence Force)
- Have a DSM 5 diagnosis of PTSD as assessed by the research team using the Clinician Administered PTSD Scale (CAPS)
- Have had no increase or initiation of new psychoactive therapy or medication intended to treat PTSD in the four weeks prior to screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they:
- Report an unstable medical condition, implanted devices such as pacemaker, medication pumps or electrodes in the heart, neurological disorder or any history of a seizure disorder or that they are currently pregnant or lactating; or
- Report a level or pattern of substance or alcohol use outside that recommended for TMS
- Are currently experiencing a severe Major Depressive Episode (as determined by the HAMD)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will be allocated to the TBS treatment condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Changes in scores on repeated continuous measures will be compared across assessment time points utilising with a Wilcoxon signed-rank test. This non-parametric statistical test is used instead of t-tests used to compare two dependant samples when population cannot be assumed to be normally distributed. This study will also examine clinically reliable change using the ClinTools software

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2016
Actual
17/10/2016
Date of last participant enrolment
Anticipated
31/07/2018
Actual
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
15
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293908 0
Government body
Name [1] 293908 0
Australian Government Department of Defence
Country [1] 293908 0
Australia
Primary sponsor type
Individual
Name
Professor David Forbes
Address
Phoenix Australia - Centre for Posttraumatic Mental Health
Level 3
Alan Gilbert Building
161 Barry St
Carlton, VIC 3053
Country
Australia
Secondary sponsor category [1] 292733 0
Individual
Name [1] 292733 0
Professor Paul Fitzgerald
Address [1] 292733 0
Monash Alfred Psychiatry Research Centre (MAPrc) Level 4, 607 St Kilda Rd
Melbourne VIC 3004
Country [1] 292733 0
Australia
Secondary sponsor category [2] 292734 0
Individual
Name [2] 292734 0
Ms Jane Nursey
Address [2] 292734 0
Phoenix Australia - Centre for Posttraumatic Mental Health
Level 3
Alan Gilbert Building
161 Barry St
Carlton, VIC 3053
Country [2] 292734 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295325 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 295325 0
Ethics committee country [1] 295325 0
Australia
Date submitted for ethics approval [1] 295325 0
05/05/2017
Approval date [1] 295325 0
10/06/2016
Ethics approval number [1] 295325 0
203/16
Ethics committee name [2] 295326 0
Department of Veterans' Affairs Human Research Ethics Committee
Ethics committee address [2] 295326 0
Ethics committee country [2] 295326 0
Australia
Date submitted for ethics approval [2] 295326 0
04/05/2016
Approval date [2] 295326 0
06/06/2016
Ethics approval number [2] 295326 0
E016/015

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

Contacts
Principal investigator
Name 65078 0
Prof David Forbes
Address 65078 0
Phoenix Australia - Centre for Posttraumatic Mental Health
University of Melbourne, Department of Psychiatry
Level 3, Alan Gilbert Building
161 Barry St,
Carlton VIC 3053
Country 65078 0
Australia
Phone 65078 0
+ 61 3 9035 5599
Fax 65078 0
Email 65078 0
[email protected]
Contact person for public queries
Name 65079 0
Jane Nursey
Address 65079 0
Phoenix Australia - Centre for Posttraumatic Mental Health
University of Melbourne, Department of Psychiatry
Level 3, Alan Gilbert Building
161 Barry St,
Carlton VIC 3053
Country 65079 0
Australia
Phone 65079 0
+61 3 9035 5599
Fax 65079 0
Email 65079 0
[email protected]
Contact person for scientific queries
Name 65080 0
Jane Nursey
Address 65080 0
Phoenix Australia - Centre for Posttraumatic Mental Health
University of Melbourne, Department of Psychiatry
Level 3, Alan Gilbert Building
161 Barry St,
Carlton VIC 3053
Country 65080 0
Australia
Phone 65080 0
+ 61 3 9035 5599
Fax 65080 0
Email 65080 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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