None listed
Conditions
Brief summary
This study is a randomised controlled trial investigating whether response to TBS can be substantially enhanced through the application of TBS at an individualised frequency. We hypothesised that treatment with an individualised TBS (Ind TBS) protocol will result in greater improvement in depressive symptoms, compared with standard TBS. So we will compare an individualised TBS intervention to standard TBS to evaluate its relative effectiveness in regards to antidepressant effects. Participants will take part in assessments of depression severity before, during and after four weeks of TBS and at another follow-up review at week 8. They will receive a course of 20 treatments of either Ind TBS or standard TBS. All assessments and treatments will take place at Epworth Camberwell.
Interventions
This is a double blind randomised controlled trial investigating whether the outcome of Theta Burst Transcranial Magnetic Stimulation (TBS) can be optimised by using individualised treatment frequency, determined by EEG. The clinical and neurophysiological outcome of standard TBS and invidualised TBS will be compared.
Participants will be randomly allocated to one of two treatment conditions:
• Standard TBS (Participants receive the predetermined pulse frequency consistent with standard treatme
This is a double blind randomised controlled trial investigating whether the outcome of Theta Burst Transcranial Magnetic Stimulation (TBS) can be optimised by using individualised treatment frequency, determined by EEG. The clinical and neurophysiological outcome of standard TBS and invidualised TBS will be compared. Participants will be randomly allocated to one of two treatment conditions: • Standard TBS (Participants receive the predetermined pulse frequency consistent with standard treatment protocol.) TBS will be applied on left side and delivered as 3-pulse 50-Hz bursts applied at 5 Hz (i.e. 50 Hz burst of 3 pulses delivered every 200ms) with a 2-second train of TBS repeated every 10 seconds (i.e. 2 seconds of TBS followed by an 8 second rest). Total number of pulses is 600. • Individualised TBS (Each participant undergoes treatment with TMS pulses applied at individualised frequency (in the range of 25-70 Hz) determined by EEG on left side.) TBS will be applied with their own individualised frequency. Other parameters are the same as in the standard group. Both groups will receive active treatment one session a day on weekdays for 20 treatment days. Participants will fortnightly take part in interviews for 4 weeks and another follow-up session at week 8. The interviewers will be blinded to the participant’s treatment group. The TBS treatment involves the application of magnetic stimulation to left DLPFC (Dorsolateral prefrontal cortex) by targeting on F3 location from the 10-20 EEG System at 120% of the RMT (resting motor threshold). 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. All treatments will be conducted by a fully qualified TMS nurse. Participants will be monitored at all times, and each treatment time, date and dosage will be logged on a participant's treatment sheet. EEG (Electroencephalogram) recordings will apply in the sessions for neurophysiological assessments. The duration of each treatment session will be about 15 mins including set up.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Diagnosis of major depressive disorder as a single or recurrent episode, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) with Mini-International Neuropsychiatric Interview-confirmed diagnosis. • 18-80 years of age. • Treatment resistant depression at Stage II of the Thase and Rush classification. • Montgomery–Asberg Depression Rating Scale (MADRS) score of >19 (moderate–severe depression). • No change or initiation of new antidepressant (or other psychoactive) therapy in the four weeks prior to screening. • Demonstrated capacity to give informed consent.
Exclusion criteria
• Inability to provide informed consent • Medically unstable • Concomitant neurological disorder or a history of a seizure disorder. • Patients who are pregnant or breastfeeding. • Active suicidal intent • Any psychotic disorder or current active psychotic symptoms • Patients who have intracranial implants.
Outcome results
None listed