None listed
Conditions
Brief summary
The purpose of this project is to investigate whether the use of a rapid form of transcranial magnetic stimulation (TMS), called Theta Burst Stimulation (TBS), is a successful treatment for patients with treatment resistant depression compared to the standard form of TMS that has been used to date. TMS involves the application of magnetic stimulation to your head and, given repeatedly over time this stimulation has been shown to change the activity levels in the brain. Previous experience has shown that people with depression may have an imbalance in the excitability, or ‘activity levels’, of cells in the brain. TMS appears to work by changing how excitable the cells of the brain are, which may help reduce or alleviate depressive symptoms. We are conducting this study to see if we can speed up the response to TMS using a rapid form of TMS called Theta Burst Stimulation (TBS). Theta burst stimulation (TBS) is a type of TMS where the magnetic pulses are applied in very short bursts (three pulses at a time) at a high frequency (30-50 pulses a second).
Interventions
It is a single blind randomised control trial where participants will receive either active daily repetitive Transcranial Magnetic Stimulation (rTMS) (20 treatments over 4 weeks) or active accelerated Theta Burst Stimulation (3 treatments per day on 7 treatment days over 4 weeks). The participant and the treater will be aware of the treatment condition however the person conducting weekly reviews will be blinded to the patient's treatment group. Participants will also be asked to submit a samp
It is a single blind randomised control trial where participants will receive either active daily repetitive Transcranial Magnetic Stimulation (rTMS) (20 treatments over 4 weeks) or active accelerated Theta Burst Stimulation (3 treatments per day on 7 treatment days over 4 weeks). The participant and the treater will be aware of the treatment condition however the person conducting weekly reviews will be blinded to the patient's treatment group. Participants will also be asked to submit a sample saliva for genetic analysis of potential predictors of response to TMS. Provision of the sample is voluntary and refusal to provide a sample will not affect the participant's inclusion in other study procedures. Both the rTMS and TBS treatments involve the application of magnetic stimulation to the left side dorso-lateral-prefrontal cortex (DLPFC), During 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. rTMS the stimulation occurs at 10 Hz, with each pulse train lasting 4 seconds and there is intertrain interval of 15 seconds. There are 75 trains of stimulation and each treatment lasts approximately 24 minutes. TBS will be provided as 3-pulse 50 - Hz bursts applied 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 and there are 3 treatments on each treatment day with a minimum 15 minute break between treatments. The treatment intensity for both rTMS and TBS will be 120% of resting motor threshold which is measured by administering single pulse TMS to the muscle controlling area of the brain. Adherence to the treatment schedule will be monitored by recording each treatment session on a participant's treatment sheet.
Sponsors
Professor Paul Fitzgerald
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- DSM-IV diagnosis of Major Depressive Disorder (MINI) - HAMD score of > 20 (moderate - severe depression) - no increase or initiation of new antidepressant therapy in 4 weeks prior to screening - have treatment resistant depression (stage II of Thase and Rush classification) - have had no increase or initiation of new antidepressant therapy in the four weeks prior to screening
Exclusion criteria
- unstable medical condition, neurological disorder, history of seizure disorder, pregnant or lactating - metal in the head, except in mouth, which may interfer with the magnetic field - current DSM-IV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another Axis 1 disorder
Outcome results
None listed