RecruitingACTRN12616001023448

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


Sponsor

Professor David Forbes

Enrollment

15 participants

Start Date

Oct 17, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for Australian military veterans who have been diagnosed with PTSD (post-traumatic stress disorder) and have not fully recovered with standard treatments. It tests a brain stimulation technique called Theta Burst Stimulation (TBS), which uses magnetic pulses to gently adjust the activity of brain cells involved in PTSD — aiming to reduce flashbacks, nightmares, and other symptoms. You may be eligible if: - You are an Australian Defence Force veteran (ex-serving) - You are 18 years of age or older - You have been diagnosed with PTSD according to DSM-5 criteria - You have not started any new psychiatric medication or therapy in the four weeks before screening You may NOT be eligible if: - You have an unstable medical condition, a pacemaker, implanted electrodes, or a history of seizures - You are currently pregnant or breastfeeding - You have significant problems with alcohol or substance use - You are currently experiencing a severe episode of major depression Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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,

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.


Locations(1)

VIC, Australia

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ACTRN12616001023448


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