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Evaluating the effectiveness of Theta Burst Stimulation (TBS) as a treatment for Posttraumatic Stress Disorder (PTSD) in an Australian Veteran Population – a pilot study

Evaluating the effectiveness of Theta Burst Stimulation (TBS) as a treatment for Posttraumatic Stress Disorder (PTSD) in an Australian Veteran Population – a pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001023448
Acronym
TBS for PTSD
Enrollment
6
Registered
2016-08-02
Start date
2016-10-17
Completion date
2018-07-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Posttraumatic stress disorder (PTSD) is a common and serious mental health problem that can have a profound impact on the person’s functioning and quality of life. Although we have effective treatments for PTSD, there are still many veterans who do not benefit from these approaches. New and innovative treatments are required. Phoenix Australia and the Monash Alfred Psychiatry Research Centre (MAPrc) are conducting a pilot study of a new intervention for PTSD known as Theta Burst Stimulation (TBS). Previous research has shown that people with PTSD may have an imbalance in the excitability, or ‘activity levels’, of cells in the brain. TBS involves the application of magnetic pulses to the head to try and change the activity level of cells in the brain. The aim of TBS treatment in PTSD is to improve the way different parts of the brain that are affected by PTSD communicate with each other, thereby reducing the symptoms of PTSD and leading to improvements in memory and thinking. To be potentially eligible to participate in the study, individuals must be a veteran, have a current diagnosis of PTSD, and be aged 18 years or above. Participation in the study involves a number of interviews, assessments and a course of TBS treatment given Monday to Friday, 15 minutes a day for four weeks at MAPrc in Prahran, Victoria. All eligible veterans will receive active bilateral TBS treatment. Participants will be assessed prior to, following and 3 months after treatment. A total of 15 participants will take part in this pilot project. This study was initiated by Professor David Forbes, Professor Paul Fitzgerald and Ms Jane Nursey and is funded by a Defence Health Foundation Grant for Medical Research.

Interventions

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 s

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.

Sponsors

Professor David Forbes
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026