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.
This study will investigate the effects of an accelerated intermittent theta burst protocol (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to target the anterior cingulate cortex (ACC) in older adults (aged 60-85) with Major Depressive Disorder (MDD). Twenty-four older adults with treatment-resistant MDD will participate in a single site, double-blind, randomized sham-controlled trial using an accelerated schedule of multiple dTMS sessions per day for 5 consecutive days. The primary goal of the study is to establish the feasibility of an accelerated aiTBS protocol of the ACC in older adults with treatment resistant depression, and to obtain preliminary evidence of treatment efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Deep 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.
In 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.
Rotman Research Institute at Baycrest
Toronto, Ontario, Canada
RECRUITINGPercentage of scheduled treatment sessions that are attended by study participants
Time frame: 6 weeks
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.
Time frame: 6 weeks
The number of participants who have prematurely withdraw and reasons for withdrawal
Time frame: 6 weeks
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.
Time frame: 1 week
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.
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
The change in functional connectivity within the default mode and central autonomic networks on Magnetic Resonance Imaging (MRI)
Time frame: 1 week
The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG
Time frame: 1 week
The change in baseline cognitive tests following 5 days of treatment and at 1-month follow-up (cognitive domains tested include executive function and memory),
Baseline cognitive tests will be measured using a neuropsychological test battery.
Time frame: 6 weeks
The change in baseline resting state heart rate variability (HRV) following a single TMS session and after 5 days of treatment
Time frame: 1 week
The change in baseline emotional processing as measured with an Affective Simon task following a single TMS session, after 5 days of treatment and at 1-month follow-up
The Affective Simon task will measure the number of correct responses to stimuli in the task.
Time frame: 6 weeks
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