The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol can reduce depressive symptoms in older adults (ages 60-85) with Major Depressive Disorder (MDD) who have not tolerated or responded to antidepressant medications. The study will evaluate whether accelerated dTMS administered over 5 consecutive days is safe and well-tolerated in this population, and whether it produces greater reductions in depressive symptoms compared to placebo stimulation.
are between 60- 85 years old (on the day of randomization)
have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer than 4 weeks but less than 5 years
did not respond to/did not tolerate, or failed to achieve remission with at least one antidepressant trial of 8 week minimum duration
are willing to provide informed consent
have a metal plate in your head (such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe
have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
have a cardiac pacemaker
have an implanted medication pump
Parallel
Active Brainsway H7-Coil Deep TMS System
DeviceDeep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel dTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions. dTMS will be administered 6-8 times a day for 5 consecutive days.
Sham Brainsway H1-Coil Deep TMS System
DeviceIn addition to the active H7-coil, a sham coil is included in the H1-coil helmet. The sham treatment will be administered 6-8 times a day for 5 consecutive days.
Percentage of scheduled treatment sessions that are attended by study participants
Participant-reported comfort and feasibility based on the frequency and type of adverse events as measured using the Adverse Events Questionnaire (AEQ)
Severity of symptoms is rated from 1 to 4, with 1 being absent and 4 being severe. Whether symptoms are perceived to be relatedTMS treatment are rated from 1 to 5, with 1 being no and 5 being definitely.
The number of participants who have prematurely withdraw and reasons for withdrawal
The change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores following the final treatment on day 5 (i.e., after 5 days of H7-coil a-iTBS) in the treatment group compared to the sham group.
An effect size (Cohen's d) of 0.5 will be considered a minimally important effective size. The MADRS ranges from 0-60, with a greater score indicating greater depressive symptoms.
Response rates compared between treatment groups following 5 days of treatment, where the response rate refers to the percentage of patients who responded to a-ITBS treatment and response is defined as a ≥50% reduction in MADRS score from baseline
Response rates will be compared from baseline to after 5 day treatment and at 1 month follow-up. MADRS scores range from 0-60, with a greater score indicating greater severity of depressive symptoms.
Remission rates compared between treatment groups following 5 days of treatment, where the remission rate is defined as MADRS score <10
MADRS scores will be compared between baseline, after 5 days of treatment and at 1-month follow-up. The MADRS ranges from 0-60, with a greater score indicating greater depressive symptoms
The change in baseline slow wave and resting state activity as measured with electroencephalography (EEG) following 5 days of treatment and at 1-month follow-up
The change in functional connectivity within the default mode and central autonomic networks on Magnetic Resonance Imaging (MRI)
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