None listed
Conditions
Brief summary
The purpose of this project is to help understand the most effective delivery methods for TMS treatment in Major Depression. Previous research suggests that administration of repetitive Transcranial Magnetic Stimulation (rTMS) in the frontal regions of the brain clearly has antidepressant effects (i.e. it helps people with depression) and that the response to rTMS is clinically significant in some patients. Most research conducted has used stimulation to a single side of the brain (left or right) using rTMS that is applied at either high (5-10 pulses per second) or low frequency (1 pulse per second). Recently we have conducted research that has suggested that we can improve the response to rTMS by combining low and high frequency stimulation types. We have done this when the stimulation is applied across both sides of the brain (high frequency on the left and low frequency on the right) and when we have applied both to the right side of the brain. Both seem more effective than stimulation applied in only one way. However, we have not compared these two methods to see if one is better than the other. That is the purpose of the current research trial.
Interventions
Priming Right Sided Transcranial Magnetic Stimulation (TMS).
TMS will be administered with a Medtronic Magpro30 magnetic stimulator using a 70mm figure of 8 coil. Prior to the commencement of treatment TMS, single pulse TMS will be used to measure the resting motor threshold (RMT) for the abductor pollicis brevis (APB) in the right hand using standard methods
20 trains of 5 seconds duration at 6 Hz and 90% of the RMT followed by 1Hz stimulation: 110% of motor threshold, 1 continuous train of
Priming Right Sided Transcranial Magnetic Stimulation (TMS). TMS will be administered with a Medtronic Magpro30 magnetic stimulator using a 70mm figure of 8 coil. Prior to the commencement of treatment TMS, single pulse TMS will be used to measure the resting motor threshold (RMT) for the abductor pollicis brevis (APB) in the right hand using standard methods 20 trains of 5 seconds duration at 6 Hz and 90% of the RMT followed by 1Hz stimulation: 110% of motor threshold, 1 continuous train of 900 pulses. Each treatment will be administered for up to four weeks, five days per week (total of 20 treatment sessions). Patients will receive an assessment at baseline, 2 and 4 weeks and the primary study analysis will be based on this data Each treatment will last approximately 20 minutes
Sponsors
Healthscope
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Have a Diagnostic and Statistical Manual -IV (DSM-IV) diagnosis of a major depressive episode. 2. Have failed to respond to adequate antidepressant medical therapy. This will be defined by at least two courses of antidepressant medication (from two medication classes) at therapeutic doses for a minimum of six weeks. Adequate daily dose will be considered to be a minimum of: 150mg of Imipramine or equivalent for tricyclic antidepressants, 20mg of Fluoxetine or equivalent for serotonin re-uptake inhibitors, 600mg of Moclobemide, 600mg of Nefazadone, 150mg of Venlafaxine, 60mg of Phenelzine or equivalent for monoamine oxidase inhibitors 3. Have a Hamilton Depression Rating Scale of > 16 (moderate – severe depression) 4. Have had no increase or initiation of new antidepressant therapy in the 4 weeks prior to screening.
Exclusion criteria
Patients who: 1. Have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating, 2. In the opinion of the investigator, are a sufficient suicidal risk to require immediate electro-convulsive therapy, 3. Have a 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