About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Have a history of a substance use disorder (including alcohol)
Within the past 3 months have a major medical illness, intracranial lesion or increased intracranial pressure, prior ischemic or hemorrhagic stroke, neurologic conditions with structural cerebral damage, stroke, multiple sclerosis, traumatic brain injury, epilepsy, a personal history of a seizure, or individuals with a family history of epilepsy or seizure in a first degree relative (please note that an individual with a first-degree relative with a history of epilepsy, or one or more seizures does not need to be excluded if the cause of epilepsy or seizure(s) is non-genetic (i.e., "non-idiopathic"), Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers), moderate to severe heart disease, cardiac pacemaker, implanted devices, or implanted medication pumps
Contraindications for TMS or MRI
Have active suicidal intent, as determined by the Principal Investigator (PI) and/or is considered a moderate-high risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk))4 by the PI. (Columbia Suicide Severity Rating Scale.
Trial design
Parallel
Treatments tested in this trial
MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of closed-loop EEG guided iTBS in adult participants with MDD.
Participant retention and completion rate of 80% or more at 4 and 6 weeks of treatment in patients receiving closed-loop guided iTBS
Secondary outcomes
Change in Hamilton Depression Rating Scale (HDRS-17)
Closed-loop iTBS delivered to the peak theta rhythm will have greater improvements in depressive symptom severity as assessed with the HDRS as compared to the participants in the trough (n=20) and random (n=20) delivered iTBS.
Sponsors and contacts
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Mayo Clinic
Lead sponsor
University of Minnesota
Collaborator
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