Mayo Clinic
The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (MDD). This is a feasibility study to test a "closed-loop" procedure which guides the timing of this FDA-cleared form of TMS. Each participant will receive an active experimental treatment, and the timing of the TMS pulses will be at one of three phases in the brain wave of interest.
This is a randomized, double-blind, 3 arm trial with a parallel design. All patients will receive an FDA cleared form of TMS called intermittent theta burst (iTBS) but will be randomized to 1) Closed-loop TMS-EEG with stimulation bursts delivered at the trough of theta waves, 2) Closed- loop TMS-EEG with stimulation bursts delivered at the peak of theta waves or 3) Closed-loop TMS-EEG random phase TMS delivery (control stimulation). Patients in all 3 study arms will wear EEG caps and undergo similar procedures to facilitate blinding. Blinded clinical raters will collect depression symptom seve…
Inclusion Criteria: * Outpatients * Voluntary patient seeking treatment with the capacity to consent * 22-60 years of age * Have Major Depressive Disorder (MDD) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57 * Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable * Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HD…
The MagVenture TMS Therapy System is based on the use of intermittent theta burst stimulation, or iTBS. This novel TMS protocol delivers treatment in only 3 minutes and is based on a patterned TMS paradigm delivered to the left-dorsolateral prefrontal cortex (LDPFC) at 120% of resting motor threshold (MT). It consists of bursts of 3 pulses at 50 Hz, with bursts repeated at 5 Hz, in a duty cycle of 2s on, 8 s off, over 3 minutes and 9 seconds, and a total of 600 pulses. For peak or trough iTBS, stimulation will consist of 3 pulses at 50 Hz delivered at intervals of their individual theta rhythm (e.g. 200 msec for a 5Hz oscillation) followed by an 8 second rest period. The pulses will be aligned to either the peak or the trough of the theta rhythm at the beginning of each pulse train. The TMS therapy will be delivered to the Left DLPFC at 120% of resting motor threshold (MT) daily for 5 days per week, for 6 weeks.
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